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U.S. Department of Health and Human Services

Medical Device Recalls
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COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffer... 2 01/30/2026 Beckman Coulter, Inc.
Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 ... 2 12/31/2025 Ferndale Laboratories, Inc.
Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa... 2 12/18/2025 Myofunctional Research Company USA
Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: ... 2 11/26/2025 Mindray DS USA, Inc. dba Mindray North America
Brand Name: HeartMate Product Name: HeartMate II® Controller (standalone) Model/Catalog Number: 10... 2 11/14/2025 Thoratec LLC
BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100; 2 11/07/2025 Becton Dickinson & Co.
DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on... 2 10/16/2025 ConvaTec, Inc
Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTER... 2 10/16/2025 American Contract Systems Inc.
One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080. 2 08/06/2025 Intersurgical Inc
One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090. 2 08/06/2025 Intersurgical Inc
REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652... 2 06/25/2025 Beckman Coulter Inc.
Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA... 2 06/20/2025 Barco N.V.
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-6... 2 03/18/2025 Angiodynamics, Inc.
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This ... 1 01/16/2025 Olympus Corporation of the Americas
Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO 2 01/07/2025 GE Medical Systems, LLC
Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO 2 01/07/2025 GE Medical Systems, LLC
DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stoo... 2 12/12/2024 Diasorin Inc.
Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2... 2 12/11/2024 Cardinal Health 200, LLC
Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT62... 2 12/11/2024 Cardinal Health 200, LLC
DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.... 2 12/06/2024 Folsom Metal Products, Inc.
Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two siz... 2 12/06/2024 Folsom Metal Products, Inc.
The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collecti... 2 11/12/2024 Topcon Medical Systems, Inc.
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gaug... 1 11/06/2024 Elekta Instrument AB
The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantita... 2 11/06/2024 Beckman Coulter, Inc.
smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714 2 10/23/2024 Smiths Medical ASD, Inc.
The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quant... 2 10/16/2024 Beckman Coulter, Inc.
VariSoft Infusion Set, Single Use. 2 09/19/2024 Unomedical A/S
Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the va... 2 09/04/2024 Mindray DS USA, Inc. dba Mindray North America
Medline Procedure kits labeled as: 1) CIRCUMCISION SET, Pack Number CIT6335; 2) CIRCUMCISION TR... 2 08/28/2024 MEDLINE INDUSTRIES, LP - Northfield
The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depen... 2 08/08/2024 Olympus Corporation of the Americas
The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depen... 2 08/08/2024 Olympus Corporation of the Americas
The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depen... 2 08/08/2024 Olympus Corporation of the Americas
QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nuc... 2 07/12/2024 Qiagen Sciences LLC
IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100 2 07/03/2024 Angiodynamics, Inc.
Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part number 261669) (1) P/N 264... 2 06/24/2024 Dental EZ Group Star Dental Division
Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is used with an air drive ... 2 06/24/2024 Dental EZ Group Star Dental Division
Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannul... 2 04/22/2024 Alcon Research, LLC
EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in mol... 2 04/10/2024 Qiagen Sciences LLC
DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620 2 01/25/2024 Diasorin Inc.
VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products E... 2 12/07/2023 Ortho-Clinical Diagnostics, INc.
VariSoft infusion set, Model Number 1002830 1 11/21/2023 Unomedical A/S
VariSoft infusion set, Model Number 1002828 1 11/21/2023 Unomedical A/S
VariSoft infusion set, Model Number 1002827 1 11/21/2023 Unomedical A/S
remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinica... 2 09/08/2023 Remel, Inc
Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of... 2 08/23/2023 Randox Laboratories Ltd.
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the fo... 2 08/03/2023 MEDLINE INDUSTRIES, LP - Northfield
Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software 2 07/20/2023 Digisonics, Inc
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) MHC VASCUL... 2 07/20/2023 MEDLINE INDUSTRIES, LP - Northfield
ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number ... 2 05/03/2023 Siemens Healthcare Diagnostics, Inc.
Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (... 2 05/03/2023 Siemens Healthcare Diagnostics, Inc.
Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC ... 2 03/28/2023 Alcon Research, LLC
Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrilla... 2 03/03/2023 HeartSine Technologies Ltd
FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround V... 3 02/03/2023 Owens & Minor Distribution, Inc.
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens Material Numb... 2 12/15/2022 Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Materi... 2 12/15/2022 Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (S... 2 12/15/2022 Siemens Healthcare Diagnostics, Inc.
BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) N... 2 12/09/2022 Becton Dickinson & Co.
The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample pr... 2 12/07/2022 Qvella Corporation
Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. B... 1 10/14/2022 TELEFLEX LLC
Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medic... 1 10/14/2022 TELEFLEX LLC
Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical ... 1 10/14/2022 TELEFLEX LLC
Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c... 1 10/14/2022 TELEFLEX LLC
Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap,... 1 10/14/2022 TELEFLEX LLC
Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b)... 2 09/29/2022 BARCO NV
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution ... 2 09/13/2022 Isopure Corp
Fischer Cone Biopsy Excisor EXCISOR, CONE FISCHER BIOPSY WD ANGL SM (5/BX) Model Number: ... 2 08/26/2022 Mckesson Medical-Surgical Inc. Corporate Office
MORRISON MEDICAL Morrison Medical OB KIT, HARD PK SEALED W/CARDBOARD BX MORMED Catalog #0967NL 2 08/26/2022 Mckesson Medical-Surgical Inc. Corporate Office
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) 2 07/11/2022 Isopure Corp
The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known t... 2 05/20/2022 Accriva Diagnostics, Inc.
DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate a... 2 04/06/2022 DeRoyal Industries Inc
DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl al... 2 04/06/2022 DeRoyal Industries Inc
DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and iso... 2 04/06/2022 DeRoyal Industries Inc
Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2 2 03/30/2022 Ansell Healthcare Products LLC
Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S08... 2 01/11/2022 PTW NORTH AMERICA CORPORATION
Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual: ACTIV5 USER MANUAL We... 2 12/16/2021 Activbody, Inc.
MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elas... 2 12/10/2021 Mentor Texas, LP.
T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intende... 2 11/10/2021 BioCheck, Inc.
ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended fo... 2 10/26/2021 Olympus Corporation of the Americas
Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Ster... 2 10/15/2021 Intuitive Surgical, Inc.
uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to ass... 2 09/29/2021 Shanghai United Imaging Healthcare Co., Ltd.
uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professiona... 2 09/29/2021 Shanghai United Imaging Healthcare Co., Ltd.
Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-M... 1 09/25/2021 Accelerated Care Plus Corporation
BD" Mouse IgG2a Isotype Control APC X39 ASR 2 08/24/2021 Becton, Dickinson and Company, BD Biosciences
Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device t... 2 08/23/2021 Beckman Coulter Inc.
IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, ... 2 08/06/2021 Stryker Medical Division of Stryker Corporation
Isolibrium Support Surface - support surface assists in the prevention and treatment of all pressure... 2 08/06/2021 Stryker Medical Division of Stryker Corporation
Sterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - Product Usage: intended ... 2 07/08/2021 Cardinal Health 200, LLC
Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N - Product Usage: inten... 2 07/08/2021 Cardinal Health 200, LLC
Sterile Radial/Femoral Angiography Drape, Catalog Number 29529 - Product Usage: intended to be used ... 2 07/08/2021 Cardinal Health 200, LLC
Nonsterile Radial/Femoral Angiography Drape, Catalog Number 29529N - Product Usage: intended to be u... 2 07/08/2021 Cardinal Health 200, LLC
Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442N - P... 2 07/08/2021 Cardinal Health 200, LLC
Sterile Femoral Angiography Drape, Catalog Numbers: a) 29460, b) 29456 - Product Usage: intended to... 2 07/08/2021 Cardinal Health 200, LLC
Nonsterile Femoral Angiography Drape, Catalog Numbers: a) 29460NB, b) 29456NB - Product Usage: inten... 2 07/08/2021 Cardinal Health 200, LLC
Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442 - Product Usage... 2 07/08/2021 Cardinal Health 200, LLC
Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: indicated for single ... 2 06/16/2021 Covidien, LP
Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product Usage: indicated ... 2 06/16/2021 Covidien, LP
Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesth... 2 06/16/2021 Covidien, LP
HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indicated for single use on a... 2 06/16/2021 Covidien, LP
Normand Remisol Advance Data Manager is a software device that interfaces between laboratory informa... 2 06/08/2021 Normand-Info S.A.S.U.
Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: u... 2 05/12/2021 Remel Inc
LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended t... 2 05/04/2021 LeMaitre Vascular, Inc.
BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria fr... 2 04/08/2021 Becton Dickinson & Co.
BD BBL Martin-Lewis Agar 20 Ea - Product Usage: use for the isolation of pathogenic Neisseria from s... 2 04/08/2021 Becton Dickinson & Co.
LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended ... 2 04/01/2021 Diasorin Inc.
Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viv... 1 03/27/2021 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI ... 1 03/27/2021 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diag... 2 03/08/2021 Siemens Healthcare Diagnostics, Inc.
Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY... 2 03/08/2021 Tosoh Bioscience Inc
Gown Kendall Blue RG, SKU CT5000 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are... 2 02/05/2021 Cardinal Health 200, LLC
Gown Kendall Blue L, SKU CT5100, CT5101 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Go... 2 02/05/2021 Cardinal Health 200, LLC
Lab Coats SMS Large White, SKU 2302LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gown... 2 02/05/2021 Cardinal Health 200, LLC
Lab Coats SMS Medium White, SKU 2301LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gow... 2 02/05/2021 Cardinal Health 200, LLC
Lab Coats SMS 2X-Large Blue, SKU 2204LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Go... 2 02/05/2021 Cardinal Health 200, LLC
Lab Coats SMS X-Large Blue, SKU 2203LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gow... 2 02/05/2021 Cardinal Health 200, LLC
Lab Coats SMS Large Blue, SKU 2202LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns... 2 02/05/2021 Cardinal Health 200, LLC
Gown Isolation W/Ties Xl Blue, SKU 2201PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" ... 2 02/05/2021 Cardinal Health 200, LLC
Gown Isolation W/Ties Univ Blu, SKU 1200PG, 2200PG, 552200PG Cardinal Health Isolation Gown, Lab ... 2 02/05/2021 Cardinal Health 200, LLC
Gown Isolation W/Ties Xl Ylw, SKU 1101PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" G... 2 02/05/2021 Cardinal Health 200, LLC
Gown Isolation W/Ties Univ Ylw, SKU 1100PG, V1100PG, 2100PG, V2100PG, 2150PG, V2100PG Cardinal He... 2 02/05/2021 Cardinal Health 200, LLC
Lab Coats SMS 2X-Large White, SKU 2304LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" G... 2 02/05/2021 Cardinal Health 200, LLC
Gown Kendall Blue XXL, SKU CT5102 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns ar... 2 02/05/2021 Cardinal Health 200, LLC
Emission Computed Tomography System Image Process System - Product Usage: intended for general Nucle... 2 01/13/2021 Philips North America, LLC
Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model ... 2 01/13/2021 GE Healthcare, LLC
GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine ... 2 01/13/2021 GE Healthcare, LLC
GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imag... 2 01/13/2021 GE Healthcare, LLC
GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imag... 2 01/13/2021 GE Healthcare, LLC
Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model... 2 01/13/2021 GE Healthcare, LLC
Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging... 2 01/13/2021 GE Healthcare, LLC
Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation d... 2 12/16/2020 Medtronic Neuromodulation
MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Product Usage: The kit is i... 2 12/04/2020 Chromsystems Instruments & Chemicals GmbH
MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - Product Usage: The kit is in... 2 12/04/2020 Chromsystems Instruments & Chemicals GmbH
MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage: The kit is int... 2 12/04/2020 Chromsystems Instruments & Chemicals GmbH
3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The kit is intended for am... 2 12/04/2020 Chromsystems Instruments & Chemicals GmbH
VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurren... 2 12/04/2020 LivaNova USA Inc
MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indic... 2 12/02/2020 Medtronic Inc.
6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usag... 2 12/02/2020 Chromsystems Instruments & Chemicals GmbH
MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is use... 2 12/02/2020 Chromsystems Instruments & Chemicals GmbH
MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is us... 2 12/02/2020 Chromsystems Instruments & Chemicals GmbH
Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring... 2 12/01/2020 Invacare Corporation
Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 069715768... 2 11/12/2020 Shanghai United Imaging Healthcare Co., Ltd.
Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used a... 2 11/05/2020 Microbiologics Inc
SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate with PE Film -... 2 10/22/2020 Sobel Westex
4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in kits labeled as foll... 2 09/25/2020 North American Rescue LLC.
Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in man... 2 09/25/2020 Stryker Medical Division of Stryker Corporation
Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device SPECT: To detect o... 2 09/02/2020 Siemens Medical Solutions USA, Inc.
E.cam or Symbia systems that use foresight detectors - Product Usage: To detect or image the distrib... 2 08/27/2020 Siemens Medical Solutions USA, Inc.
Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 880000... 2 08/18/2020 Shanghai United Imaging Healthcare Co., Ltd.
uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated b... 2 08/13/2020 Shanghai United Imaging Healthcare Co., Ltd.
uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by ... 2 08/13/2020 Shanghai United Imaging Healthcare Co., Ltd.
Remisol Advance running Software Version 1.12 The Normand Info Remisol Advance Data Manager colle... 2 07/31/2020 Normand-Info S.A.S.U.
MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument ... 2 07/10/2020 DiaSorin Molecular LLC
MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for t... 2 07/10/2020 DiaSorin Molecular LLC
MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: i... 2 07/10/2020 DiaSorin Molecular LLC
Isolation Droplet Bundle Kit 2 06/26/2020 ROi CPS LLC
Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD ; 30004 LokomatPro L6.2 120V Kombi; 300... 2 06/23/2020 Hocoma AG
Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Ma... 2 05/13/2020 The Magstim Company Limited
Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major Depres... 2 05/13/2020 The Magstim Company Limited
PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units), P1028888-001 PSU (u... 2 04/23/2020 bioMerieux, Inc.
Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R0... 2 04/15/2020 Shanghai United Imaging Healthcare Co., Ltd.
Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell l... 2 04/14/2020 Life Technologies Corporation
Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell... 2 04/14/2020 Life Technologies Corporation
Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from non-small cel... 2 04/14/2020 Life Technologies Corporation
Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lu... 2 04/14/2020 Life Technologies Corporation
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patie... 2 04/13/2020 Merit Medical Systems, Inc.
The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG ... 2 04/06/2020 Qualigen Inc
Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser System is desig... 2 04/01/2020 Ra Medical Systems, Inc.
LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/... 2 04/01/2020 Physio-Control, Inc.
Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin S... 2 03/20/2020 Siemens Healthcare Diagnostics, Inc.
Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin ... 2 03/20/2020 Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL). Product Usa... 2 03/20/2020 Siemens Healthcare Diagnostics, Inc.
Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of tot... 2 03/20/2020 Siemens Healthcare Diagnostics, Inc.
Dimension Vista® Total Bilirubin Flex® reagent cartridge -In vitro Diagnostic for the determinatio... 2 03/20/2020 Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ... 2 03/20/2020 Siemens Healthcare Diagnostics, Inc.
Iliac Screws, multiple sizes, Article Nos. B36020500 B36020570 B36020580 B36020590 B36027500 ... 2 03/11/2020 Medicrea International
Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B3600454... 2 03/11/2020 Medicrea International
LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The cir... 2 03/04/2020 Organ Recovery Systems, Inc.
Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Serv... 2 03/03/2020 Normand-Info S.A.S.U.
IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D) (600 tests) an... 2 02/24/2020 Siemens Healthcare Diagnostics, Inc.
IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product Usage: For in v... 2 02/24/2020 Siemens Healthcare Diagnostics, Inc.
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centri... 2 01/19/2020 Isopure Corp
Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended... 2 12/12/2019 The Binding Site Group, Ltd.
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of sin... 1 11/01/2019 Philips Medical Systems (Cleveland) Inc
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of sin... 1 11/01/2019 Philips Medical Systems (Cleveland) Inc
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of sin... 1 11/01/2019 Philips Medical Systems (Cleveland) Inc
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of sin... 1 11/01/2019 Philips Medical Systems (Cleveland) Inc
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of sin... 1 11/01/2019 Philips Medical Systems (Cleveland) Inc
BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor Part/Catalo... 2 10/07/2019 Becton Dickinson & Company
The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemi... 2 09/30/2019 Beckman Coulter Inc.
Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulatin... 2 08/07/2019 Integra LifeSciences Corp.
Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 10L GP Bath Model Number: FSGPD10 2 06/21/2019 Thermo Fisher Scientific (Asheville) LLC
Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 20L GP Bath Model Number: FSGPD20 2 06/21/2019 Thermo Fisher Scientific (Asheville) LLC
Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 5L GP Bath Model Number: FSGPD05 2 06/21/2019 Thermo Fisher Scientific (Asheville) LLC
Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear M... 2 05/03/2019 GE Healthcare, LLC
NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT syst... 2 05/03/2019 GE Healthcare, LLC
NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for general Nuclear Medicine im... 2 05/03/2019 GE Healthcare, LLC
NM/CT 850 Product Usage: The GE NM/CT 850 system is intended for general Nuclear Medicine imagin... 2 05/03/2019 GE Healthcare, LLC
NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging syste... 2 05/03/2019 GE Healthcare, LLC
Discovery NM/CT 670 ES Product Usage: The GE Discovery NM/CT 670 system is a medical tool intende... 2 05/03/2019 GE Healthcare, LLC
Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intend... 2 05/03/2019 GE Healthcare, LLC
Discovery NM/CT 670 CZT, Model/Catalogue/Code H3906CT Product Usage: The GE Discovery NM/CT 670 ... 2 05/03/2019 GE Healthcare, LLC
Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear ima... 2 05/03/2019 GE Healthcare, LLC
NM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use... 2 05/03/2019 GE Healthcare, LLC
cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Cat... 2 04/10/2019 Roche Diagnostics Corporation
COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein A-1 ver.2... 2 04/10/2019 Roche Diagnostics Corporation
Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary... 3 03/28/2019 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729-00 02340-98729-00 ... 2 03/09/2019 Reckitt Benckiser LLC
Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89455-00 02340-89456-... 2 03/09/2019 Reckitt Benckiser LLC
ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY fo... 2 12/22/2018 Tosoh Bioscience Inc
Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing o... 2 12/13/2018 GE Healthcare, LLC
Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. N... 3 11/30/2018 Helena Laboratories, Inc.
EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 Advanced XL ... 2 11/03/2018 Qiagen Sciences LLC
Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplements ... 3 10/26/2018 Acumedia Manufacturers, Inc.
Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazone for the selective iso... 3 10/26/2018 Acumedia Manufacturers, Inc.
Dimension® Ammonia Flex® reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnost... 2 10/11/2018 Siemens Healthcare Diagnostics, Inc.
Dimension Vista® Ammonia Flex® reagent cartridge / AMM Dimension: The AMM method is an in vitro dia... 2 10/11/2018 Siemens Healthcare Diagnostics, Inc.
Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is used for co... 2 10/10/2018 Reckitt Benckiser LLC
Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89... 2 09/24/2018 Reckitt Benckiser LLC
VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Pro... 3 09/17/2018 Ortho-Clinical Diagnostics
IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The IsoFlex LAL support surfa... 2 09/15/2018 Stryker Medical Division of Stryker Corporation
VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage For in vitro diagnostic... 3 09/14/2018 Ortho-Clinical Diagnostics
Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immu... 2 08/24/2018 Tecan US, Inc.
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and... 3 08/23/2018 Euro Diagnostica AB
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoant... 3 08/23/2018 Euro Diagnostica AB
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and... 3 08/23/2018 Euro Diagnostica AB
is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detec... 3 08/23/2018 Euro Diagnostica AB
BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 9... 2 07/06/2018 Smiths Medical ASD Inc.
VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use o... 2 06/29/2018 BioMerieux SA
The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinic... 2 06/12/2018 BioMerieux SA
The VITEK® 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clini... 2 06/12/2018 BioMerieux SA
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implanta... 2 06/12/2018 St Jude Medical Inc.
PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, inten... 2 06/12/2018 St Jude Medical Inc.
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pa... 2 06/12/2018 St Jude Medical Inc.
Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, ... 2 06/12/2018 St Jude Medical Inc.
Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM121... 2 06/12/2018 St Jude Medical Inc.
Assurity MRI Model Numbers: PM1272, PM2272 Implantation of a single-chamber pulse generator, dual-c... 2 06/12/2018 St Jude Medical Inc.
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devic... 2 06/12/2018 St Jude Medical Inc.
PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devices are implantable pace... 2 06/12/2018 St Jude Medical Inc.
Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Si... 2 06/08/2018 Siemens Medical Solutions USA, Inc.
nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by trained p... 2 05/31/2018 NordicNeuroLab AS
AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112 2 05/30/2018 WRP Asia Pacific Sdn Bhd
iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated ... 2 05/18/2018 Beckman Coulter Inc.
Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151 2 05/15/2018 CooperSurgical, Inc.
ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for... 2 05/08/2018 Hyphen BioMed
ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-depe... 2 05/08/2018 Hyphen BioMed
ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative screening assay intended f... 2 05/08/2018 Hyphen BioMed
BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-771... 2 05/04/2018 Beckman Coulter Inc.
MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune com... 2 04/24/2018 Diagnostic Hybrids, Inc.
Halyard Closed Suction System for Adults, Multi-Access®Port®Closed®Suction®System®for®Adults. Used ... 2 04/18/2018 Halyard Health, Inc
Halyard Closed Suction System for Adults, Turbo- cleaning®Closed®Suction®System®for®Adults,®Double®S... 2 04/18/2018 Halyard Health, Inc
Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or sem... 2 04/18/2018 Halyard Health, Inc
Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid ... 2 04/11/2018 The Magstim Company Limited
Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: 105-007867-00 (20L cont... 2 04/09/2018 Mindray DS USA, Inc. dba Mindray North America
Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer; Part Numbers: (1) 105-00... 2 04/09/2018 Mindray DS USA, Inc. dba Mindray North America
Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)1019030200607... 2 03/30/2018 Life Technologies Corporation
Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas Module 3 i... 3 03/28/2018 Mindray DS USA, Inc. dba Mindray North America
U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032... 2 03/19/2018 United Orthopedic Corporation
U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total K... 2 03/19/2018 United Orthopedic Corporation
ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection ... 2 03/15/2018 Hyphen BioMed
ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of hepari... 2 03/15/2018 Hyphen BioMed
VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United S... 2 02/08/2018 Cyberonics, Inc
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following: ... 1 02/01/2018 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following: a. Evera MR... 1 02/01/2018 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following: a. Visia A... 1 02/01/2018 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR ICD DF1 (Pro... 1 02/01/2018 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Labeled as the following: ... 1 02/01/2018 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Labeled as the following: ... 1 02/01/2018 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following: a. Vi... 1 02/01/2018 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following: a. Evera S DR ICD... 1 02/01/2018 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance Data Manage... 2 12/13/2017 Normand Informatique
CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 ... 2 12/06/2017 GE Medical Systems Information Technologies, Inc.
Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 0036570... 2 12/06/2017 Roche Diabetes Care, Inc.
Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To detect or image the distri... 2 11/16/2017 Siemens Medical Solutions USA, Inc.
Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To detect or image the distr... 2 11/16/2017 Siemens Medical Solutions USA, Inc.
iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolutio... 2 10/04/2017 Optovue, Inc.
iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. I... 2 10/04/2017 Optovue, Inc.
iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) i... 2 10/04/2017 Optovue, Inc.
Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implantable cardioverter defib... 2 09/28/2017 Sorin Group Italia SRL - CRF
Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, Implantable cardioverter defibrill... 2 09/28/2017 Sorin Group Italia SRL - CRF
Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, Implantable cardioverter defibrill... 2 09/28/2017 Sorin Group Italia SRL - CRF
Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implantable cardioverter defi... 2 09/28/2017 Sorin Group Italia SRL - CRF
Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN 08031527015484, Implantable cardioverter defibr... 2 09/28/2017 Sorin Group Italia SRL - CRF
Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implantable cardioverter defib... 2 09/28/2017 Sorin Group Italia SRL - CRF
eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated is... 2 09/12/2017 bioMerieux, Inc.
VNS Therapy® AspireHC® Generator, VNS Therapy® AspireSR® Generator. Model No. 106. Product Usage... 2 08/11/2017 Cyberonics, Inc
VNS Therapy® AspireHC® Generator, VNS Therapy® AspireSR® Generator. Model No. 105. Product Usage... 2 08/11/2017 Cyberonics, Inc
Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicat... 1 08/10/2017 Cook Medical Incorporated
Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system combines magnetic resonan... 2 08/02/2017 GE Medical Systems, LLC
Converters(R) Tiburon(R) Arthroscopy Drape, REF 9414, STERILE EO, Qty. 1, Cardinal Health, Waukegan,... 2 07/07/2017 Cardinal Health 200, LLC
Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, Qty. 1, Cardina... 2 07/07/2017 Cardinal Health 200, LLC
The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 C... 3 06/29/2017 Medtest Holdings, Inc.
Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the ... 3 06/01/2017 Acumedia Manufacturers, Inc.
Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Nu... 2 05/22/2017 Perkinelmer Life Sciences, Inc.
OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARA... 2 05/18/2017 Sorin Group Italia SRL - CRF
INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARAD... 2 05/18/2017 Sorin Group Italia SRL - CRF
PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT-D 9750, SonR 8770, RF ... 2 05/18/2017 Sorin Group Italia SRL - CRF
ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (... 2 05/03/2017 Abbott Laboratories
BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglob... 3 04/26/2017 Becton Dickinson & Co.
Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Ox... 2 04/10/2017 Draegar Medical Systems, Inc.
Delta XL, Catalog Number: MS18596 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four... 2 04/10/2017 Draegar Medical Systems, Inc.
Kappa, Catalog Number: MS18853 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Ox... 2 04/10/2017 Draegar Medical Systems, Inc.
IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 10381181, 1038... 2 03/09/2017 Siemens Healthcare Diagnostics, Inc
IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Pr... 2 03/09/2017 Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG m... 2 03/09/2017 Siemens Healthcare Diagnostics, Inc
Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip).... 2 03/03/2017 Parker Medical
Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (... 2 01/24/2017 Roche Diagnostics Operations, Inc.
Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko Clinical Chem... 2 01/13/2017 The Binding Site Group, Ltd.
MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS® easyMAG® system is an... 1 01/13/2017 BioMerieux SA
Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 The Siemens Biograph mCT and Biograph mCT F... 2 01/10/2017 Siemens Medical Solutions USA Inc.
Biograph mCT X-3R, Material Number 10248673 The Siemens Biograph mCT and Biograph mCT Flow systems... 2 01/10/2017 Siemens Medical Solutions USA Inc.
Biograph mCT S(64)-4R, Material Number 10248672 The Siemens Biograph mCT and Biograph mCT Flow sys... 2 01/10/2017 Siemens Medical Solutions USA Inc.
Biograph mCT S(40)-4R, Material Number 10248671 The Siemens Biograph mCT and Biograph mCT Flow sys... 2 01/10/2017 Siemens Medical Solutions USA Inc.
Biograph mCT Flow Edge-4R, Material Number 10528955 The Siemens Biograph mCT and Biograph mCT Flow... 2 01/10/2017 Siemens Medical Solutions USA Inc.
Biograph mCT S(64)-3R, Material Number 10248669 The Siemens Biograph mCT and Biograph mCT Flow sys... 2 01/10/2017 Siemens Medical Solutions USA Inc.
Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT and Biograph mCT Flow sys... 2 01/10/2017 Siemens Medical Solutions USA Inc.
Biograph mCT-X w/TrueV Upgrade, Material Number 10250745 The Siemens Biograph mCT and Biograph mCT... 2 01/10/2017 Siemens Medical Solutions USA Inc.
BIOGRAPH mCT 20 Excel, Material Number 10507786 The Siemens Biograph mCT and Biograph mCT Flow sys... 2 01/10/2017 Siemens Medical Solutions USA Inc.
Biograph mCT X-4R, Material Number 10248670 The Siemens Biograph mCT and Biograph mCT Flow systems... 2 01/10/2017 Siemens Medical Solutions USA Inc.
Biograph mCT Flow 40-4R, Material Number 10529159 The Siemens Biograph mCT and Biograph mCT Flow s... 2 01/10/2017 Siemens Medical Solutions USA Inc.
Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" CRT -D SureScan", ... 2 01/07/2017 Medtronic Inc., Cardiac Rhythm and Heart Failure
EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determinat... 3 12/22/2016 PerkinElmer Health Sciences, Inc.
Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code 44965 NS; C-Se... 2 12/08/2016 Halyard Health, Inc
LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chem... 2 11/21/2016 Diasorin Inc.
VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides per sales unit) and 83... 2 10/17/2016 Ortho-Clinical Diagnostics
Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the bod... 2 10/08/2016 Siemens Medical Solutions USA, Inc.
Symbia T Series SPECT + CT Product Usage 1) SPECT: To Detect or image the distribution of radion... 2 10/08/2016 Siemens Medical Solutions USA, Inc.
BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, Plastic Non-Surgical Is... 2 09/30/2016 Cardinal Health
The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that ... 2 09/15/2016 Circulatory Technology Inc
e.cam and Symbia E gamma camera systems with patient beds To detect or image the distribution of ... 2 09/08/2016 Siemens Medical Solutions USA, Inc.
SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular Micros... 2 09/01/2016 Nidek Inc
AlignRT® Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to positio... 2 08/25/2016 Vision RT Ltd
1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product Usage: The HYDRO LeMai... 2 08/16/2016 LeMaitre Vascular, Inc.
1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J Product Usage: ... 2 08/16/2016 LeMaitre Vascular, Inc.
1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile REF # 1010-00 Product Usage: The HYDRO LeMait... 2 08/16/2016 LeMaitre Vascular, Inc.
BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains CD3 FIT... 3 08/09/2016 Becton, Dickinson and Company, BD Biosciences
VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No.... 2 07/23/2016 Ortho-Clinical Diagnostics
Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE... 2 07/11/2016 Varian Medical Systems, Inc.
Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE; Radiolog... 2 07/11/2016 Varian Medical Systems, Inc.
Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system... 2 05/04/2016 Toshiba American Medical Systems Inc
Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemo... 2 04/26/2016 Hardy Diagnostics
Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the halo syste... 2 04/19/2016 Ossur H / F
Ossur Lil Angel Vest P3 Kodel. Pediatric sized vest is a support structure used with the halo syste... 2 04/19/2016 Ossur H / F
Ossur Lil Angel Vest P3 Sorbatex. Pediatric sized vest is a support structure used with the halo sys... 2 04/19/2016 Ossur H / F
Ossur Lil Angel Vest P3 Lambswool. Pediatric sized vest is a support structure used with the halo sy... 2 04/19/2016 Ossur H / F
Ossur Lil Angel Vest P2 Lambswool. Pediatric sized vest is a support structure used with the halo s... 2 04/19/2016 Ossur H / F
Ossur Lil Angel Vest P2 Sorbatex. Pediatric sized vest is a support structure used with the halo s... 2 04/19/2016 Ossur H / F
IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21, LKE21(D), LKE25 SMN: 10381132, 107028... 2 03/24/2016 Siemens Healthcare Diagnostics, Inc
IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D) SMN: 10... 2 03/24/2016 Siemens Healthcare Diagnostics, Inc
Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 10489099 Product Usage:... 2 03/24/2016 Siemens Healthcare Diagnostics, Inc
Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762 SMN: 1... 2 03/08/2016 Siemens Healthcare Diagnostics, Inc
Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack Catalog Number: 04634452 SMN... 2 03/08/2016 Siemens Healthcare Diagnostics, Inc
Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference) Catalog Number: 0463... 2 03/08/2016 Siemens Healthcare Diagnostics, Inc
VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC 1 VERSYS 8 INCH BEADE... 2 02/22/2016 Zimmer Biomet, Inc.
VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" T... 2 02/22/2016 Zimmer Biomet, Inc.
VERSYS 7.5 INCH BEADED FC prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" T... 2 02/22/2016 Zimmer Biomet, Inc.
VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" T... 2 02/22/2016 Zimmer Biomet, Inc.
CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes ... 2 02/22/2016 Zimmer Biomet, Inc.
CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes ... 2 02/22/2016 Zimmer Biomet, Inc.
PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile ... 2 02/22/2016 Zimmer Biomet, Inc.
NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, knee, patellofemorotibi... 2 02/22/2016 Zimmer Biomet, Inc.
CR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral LPS Flex Porous Femoral prosthesis, knee, ... 2 02/22/2016 Zimmer Biomet, Inc.
NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat Fem NexGen Knee LPS Po... 2 02/22/2016 Zimmer Biomet, Inc.
NexGen Knee LPS Porous FEM NexGen Knee LPS Option FEM NexGen Knee Lock FEM prosthesis, knee, pate... 2 02/22/2016 Zimmer Biomet, Inc.
NexGen Knee CR Porous FEM NexGen Knee CR Precoat FEM prosthesis, knee, patellofemorotibial, semi-c... 2 02/22/2016 Zimmer Biomet, Inc.
NexGen LPS-FLEX Option Femoral NexGen LPS-FLEX Precoat Femoral prosthesis, knee, patellofemorotibi... 2 02/22/2016 Zimmer Biomet, Inc.
NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous FEM prosthesis, knee, ... 2 02/22/2016 Zimmer Biomet, Inc.
LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/... 2 02/22/2016 Zimmer Biomet, Inc.
The e.cam Dual Signature Gamma Camera system. Used to detect or image the distribution of radionucl... 2 01/21/2016 Siemens Medical Solutions USA, Inc.
Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme o... 2 01/07/2016 Siemens Healthcare Diagnostics Inc
RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-1111; Rx o... 2 12/31/2015 RenovoRx, Inc.
MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed 640G insulin pump syst... 2 12/17/2015 Medtronic MiniMed Inc.
MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model No. MMT-1711 and MMT-1712 The MiniMed 620G and Min... 2 12/17/2015 Medtronic MiniMed Inc.
Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource Bergen), Kroger, Medli... 2 12/16/2015 Bestmed, LLC
GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system combines magnetic reso... 2 11/10/2015 GE Healthcare
Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B -... 2 11/09/2015 Biocare Medical, LLC
e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or image the di... 2 11/04/2015 Siemens Medical Solutions USA, Inc.
KimVent* Closed Suction System for Adults, 12 F, T-Piece (Product Code 2155); KimVent* Closed Suctio... 2 08/31/2015 Halyard Health, Inc
KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Elbow (Product Code 206); KimVent* Clos... 2 08/31/2015 Halyard Health, Inc
KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Manifold (Product Code 201) A tracheob... 2 08/31/2015 Halyard Health, Inc
KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Y-Adapter (Product Code 195); KimVent* ... 2 08/31/2015 Halyard Health, Inc
KimVent* Multi-Access Port Replacement Catheter for Adults, Endotracheal,16 F (Product Code 240165-5... 2 08/31/2015 Halyard Health, Inc
KimVent* Multi-Access Port Closed Suction System for Adults,Tracheostomy, DSY, MDI, 14 F (Product Co... 2 08/31/2015 Halyard Health, Inc
KimVent* Multi-Access Port Replacement Catheter for Adults,Tracheostomy, 14 F (Product Code 2401453-... 2 08/31/2015 Halyard Health, Inc
KimVent* Multi-Access Port Closed Suction System for Adults, Endotracheal, DSY, 14 F (Product Code 2... 2 08/31/2015 Halyard Health, Inc
KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 2271418) A t... 2 08/31/2015 Halyard Health, Inc
KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece (Product Code 22705); KimVen... 2 08/31/2015 Halyard Health, Inc
KimVent* Closed Suction Systems for Adults, 14 F, Qwik Clip (Product Code 2273) A tracheobronchial ... 2 08/31/2015 Halyard Health, Inc
KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE (Product Code 227); KimVent* Tur... 2 08/31/2015 Halyard Health, Inc
NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, 14F (Product Code 2V2210... 2 08/31/2015 Halyard Health, Inc
NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, Directional Tip, 14F (Pr... 2 08/31/2015 Halyard Health, Inc
KimVent* Closed Suction System for Adults, 14 F, DSE, DT (Product Code 22109) A tracheobronchial su... 2 08/31/2015 Halyard Health, Inc
KimVent* Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 22108); KimVent* Closed Suct... 2 08/31/2015 Halyard Health, Inc
KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE, MDI (Product 8224); KimVent* Wet Pak*... 2 08/31/2015 Halyard Health, Inc
KimVent* Closed Suction System for Adults, 14 F, DSE (Product Code 2210); KimVent* Closed Suction Sy... 2 08/31/2015 Halyard Health, Inc
KimVent* Wet Pak* Closed Suction System for Adults, 14 F, Elbow (Product Code 2276); KimVent* Wet Pa... 2 08/31/2015 Halyard Health, Inc
KimVent* Closed Suction System for Adults, 14 F, Elbow, D-Tip (Product Code 2219) A tracheobronchia... 2 08/31/2015 Halyard Health, Inc
KimVent* Closed Suction System for Adults, 12 F, Elbow (Product Code 216); KimVent* Closed Suction ... 2 08/31/2015 Halyard Health, Inc
NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, Directional Tip, 14F (Product Code 2... 2 08/31/2015 Halyard Health, Inc
NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece  MDI Adapter, 14F (Product Cod... 2 08/31/2015 Halyard Health, Inc
NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, 14F (Product Code 2V220135); NovaPlu... 2 08/31/2015 Halyard Health, Inc
KimVent* Closed Suction System for Adults, 14 F, MDI, T-Piece, 12 in Tracheostomy (Product Code 2201... 2 08/31/2015 Halyard Health, Inc
KimVent* Turbo-Cleaning Closed Suction System for Adults, 10 F, T-Piece (Product Code 227105) A tra... 2 08/31/2015 Halyard Health, Inc
KimVent* Closed Suction System for Adults, 12 F, T-Piece,12 in Tracheostomy (Product Code 215135); ... 2 08/31/2015 Halyard Health, Inc
KimVent* Closed Suction System for Adults, 14 F, D-Tip, T-Piece (Product Code 22059); KimVent* Close... 2 08/31/2015 Halyard Health, Inc
KimVent* Wet Pak* Closed Suction System for Adults, 14 F, T-Piece (Product Code 22056); KimVent* Wet... 2 08/31/2015 Halyard Health, Inc
KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DT, T-Piece (Product Code 220569) A trach... 2 08/31/2015 Halyard Health, Inc
KimVent* Closed Suction System for Adults, 14 F, T-Piece, MDI (Product Code 8308) A tracheobronchia... 2 08/31/2015 Halyard Health, Inc
KimVent* Wet Pak* Closed Suction System for Pediatrics, 10 F, Y Adapter (Product Code 8281) A trach... 2 08/31/2015 Halyard Health, Inc
COULTER ISOTON 4 Diluent, Catalog No. 8547148. The diluent provides the ability to analyze portions... 2 08/28/2015 Beckman Coulter Inc.
HUDSON RCI, Sheridan SHER-I BRONCH Accessory Pack, Rx Only, Sterile. Used to aspirate liquids or... 1 08/20/2015 Teleflex Medical
Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate packaged: 10 places/slee... 2 07/29/2015 Hardy Diagnostics
Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 plat... 2 07/29/2015 Hardy Diagnostics
Hardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x100mm monoplate packaged... 2 07/29/2015 Hardy Diagnostics
Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & B ... 2 07/16/2015 Alere Scarborough, Inc. dba Binax, Inc.
The VariSource iX series afterloader systems are computer controlled remote electro/mechanical syste... 2 06/26/2015 Varian Medical Systems Inc
Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenu... 2 06/26/2015 ITC-Nexus Dx
The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit... 2 06/26/2015 Diamedix Corporation
TomoMobile, Hi-Art System, H-0000-0003, TomoTherapy 1240 Deming Way, Madison, WI 53717 The TomoT... 2 06/26/2015 Accuray Incorporated
IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Mater... 2 06/25/2015 Siemens Healthcare Diagnostics, Inc.
Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver Single... 1 06/24/2015 Teleflex Medical
LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is f... 2 06/24/2015 Cook Inc.
I-Portal® NOTC and VNG; a device used to measure, record, or visually display the involuntary moveme... 2 06/12/2015 Neuro Kinetics, Inc.
M/L Taper with Kinectiv® Technology. prosthesis, hip, semi-constrained (metal uncemented acetabular... 1 06/08/2015 Zimmer, Inc.
Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A. 2 05/29/2015 Smiths Medical ASD, Inc.
Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay, performed on the Ale... 2 05/26/2015 Alere Scarborough, Inc. dba Binax, Inc.
COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. For use as an isotonic buffered diluent... 2 05/15/2015 Beckman Coulter Inc.
Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear ... 2 05/13/2015 Philips Medical Systems (Cleveland) Inc
Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella) Cat no: G327... 2 04/14/2015 Hardy Diagnostics
E.CAM emission computed tomography system used to detect or image the distribution of radionuclides ... 2 03/19/2015 Siemens Medical Solutions USA, Inc.
Symbia E is a multi-purpose SPECT system used to detect or image the distribution of radionuclides i... 2 03/19/2015 Siemens Medical Solutions USA, Inc.
GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations. ... 2 03/13/2015 GE Healthcare
The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing, staging and res... 2 02/10/2015 Siemens Medical Solutions USA, Inc.
The Siemens Symbia T series is intended to aid in detecting, localizing, diagnosing, staging and res... 2 02/10/2015 Siemens Medical Solutions USA, Inc.
Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometri... 2 01/20/2015 BD Biosciences, Systems & Reagents
CDC Anaerobe 5% Sheep Blood Agar CDC Anaerobe 5% Sheep Blood Agar is an enriched, nonselective cu... 2 01/14/2015 Becton Dickinson & Co.
e.cam -emission computed tomography system Used to detect or image the distribution of radionucli... 2 01/06/2015 Siemens Medical Solutions USA, Inc.
The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only attenuation co... 2 01/06/2015 Siemens Medical Solutions USA, Inc.
The Siemens Symbia T series is intended for use by appropriately trained health care professionals t... 2 01/06/2015 Siemens Medical Solutions USA, Inc.
The Siemens Symbia S series is intended for use by appropriately trained health care professionals t... 2 01/06/2015 Siemens Medical Solutions USA, Inc.
GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC, H3000YD, H2508P... 2 12/16/2014 GE Healthcare, LLC
GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia I... 2 12/16/2014 GE Healthcare, LLC
Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, ... 2 12/16/2014 GE Healthcare, LLC
Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Models H3100RC, H3... 2 12/16/2014 GE Healthcare, LLC
Optima NM/CT 640, Models H3100YA, H3100YC. Product Usage: The GE Optima NM/CT 640 system is in... 2 12/16/2014 GE Healthcare, LLC
Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for verificati... 2 12/16/2014 Varian Medical Systems, Inc.
Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth supplemen... 2 12/12/2014 Remel Inc
Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit. The ... 2 12/12/2014 Invacare Corporation
Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A growth sup... 2 11/10/2014 Remel Inc
Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patients ... 2 11/08/2014 Zimmer, Inc.
Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient D... 2 10/28/2014 Merge Healthcare, Inc.
IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD. For in... 2 10/23/2014 Siemens Healthcare Diagnostics
ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage: Th... 2 10/09/2014 Bio-Detek, Inc.
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900... 2 10/09/2014 Bio-Detek, Inc.
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part nu... 2 10/09/2014 Bio-Detek, Inc.
ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8900-4013 Product Usa... 2 10/09/2014 Bio-Detek, Inc.
Dimension Vista® Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the cal... 2 10/06/2014 Siemens Healthcare Diagnostics, Inc.
The Symbia T Series consists of the T16, T6, T2, and T. The Symbia T integrates state-of-the-art SPE... 2 09/29/2014 Siemens Medical Solutions USA, Inc.
The Symbia Intevo series consists of the Intevo 16, Intevo 6 and Intevo 2. This manual also describe... 2 09/29/2014 Siemens Medical Solutions USA, Inc.
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Electrodes ... 2 09/17/2014 Bio-Detek, Inc.
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These M... 2 09/17/2014 Bio-Detek, Inc.
CENTRAL LINE FULL BODY DRAPE CUSTOMED CONTENTS: (1) WRAPPER 30" X 30" (2) MASK SURGICAL W/ VI... 1 08/29/2014 Customed, Inc
Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/ Components) NWP2INS... 2 08/11/2014 Integra LifeSciences Corp.
Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Medtronic Min... 2 08/10/2014 Medtronic MiniMed Inc.
Symbia E camera system. Emission Computed Tomography System used to detect or image the distributio... 2 07/11/2014 Siemens Medical Solutions USA, Inc.
e.cam camera system. Emission Computed Tomography System used to detect or image the distribution o... 2 07/11/2014 Siemens Medical Solutions USA, Inc.
BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in v... 3 07/11/2014 Becton Dickinson & Co.
LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system which uses multi proje... 2 06/24/2014 LAP of America Laser Applications, LLC
Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used t... 2 06/20/2014 SeaSpine Inc
CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control ... 2 06/03/2014 LAP of America Laser Applications, LLC
Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC (37603), Activa PC+S (... 2 04/29/2014 Medtronic Neuromodulation
Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips ... 2 04/26/2014 Philips Medical Systems (Cleveland) Inc
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. ... 2 04/24/2014 Varian Medical Systems, Inc.
Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc. 3910 Brickway Blvd. Sa... 2 03/26/2014 Trivascular, Inc
DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provid... 2 03/25/2014 Velocity Medical Solutions, LLC
DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product Usage: Limb holders a... 2 03/14/2014 DeRoyal Industries Inc
CELLTRACKS ANALYZER II® (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II® is a se... 2 03/13/2014 Veridex, LLC
GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system... 2 03/13/2014 GE Healthcare, LLC
GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. For Dual-Head Variable Angle ... 2 03/13/2014 GE Healthcare, LLC
Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The int... 2 03/13/2014 GE Healthcare, LLC
bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/... 2 03/12/2014 Biomerieux Inc
GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the... 2 03/06/2014 GE Healthcare, LLC
Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyoph... 2 02/26/2014 Remel Inc
MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm, REF 3... 2 02/10/2014 Ecolab Inc
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96",... 2 02/10/2014 Ecolab Inc
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 244 cm, ... 2 02/10/2014 Ecolab Inc
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x 244 cm, 5"... 2 02/10/2014 Ecolab Inc
MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 ... 2 02/10/2014 Ecolab Inc
Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standar... 2 02/07/2014 Integra LifeSciences Corp.
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient D... 2 01/22/2014 GE Healthcare, LLC
GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM) is intended to provide... 2 01/14/2014 GE Healthcare, LLC
Integra Small Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 3... 2 01/03/2014 Integra LifeSciences Corp.
Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 3... 2 01/03/2014 Integra LifeSciences Corp.
CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer semi-constrained ce... 2 12/30/2013 Zimmer, Inc.
Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterpr... 2 12/27/2013 Integra LifeSciences Corp.
Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contai... 2 12/18/2013 Remel Inc
MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated isolati... 2 12/18/2013 Roche Diagnostics Operations, Inc.
Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1. " Examination an... 2 12/17/2013 Karl Storz Endoscopy America Inc
Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs,... 1 12/13/2013 GE Healthcare, LLC
NexGen® Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Tibial Baseplates are par... 2 12/11/2013 Zimmer, Inc.
NexGen Complete Knee Solution Porous Patella Drill Guide-26mm dia./10mm thickness Non sterile, Rx ... 2 12/06/2013 Zimmer, Inc.
NexGen Complete Knee Solution Porous Patella Drill Guide-29mm dia./10mm thickness Non sterile, Rx ... 2 12/06/2013 Zimmer, Inc.

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