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U.S. Department of Health and Human Services

Medical Device Recalls
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VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST... 1 04/25/2024 Biomerieux Inc
TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dis... 2 04/25/2024 Howmedica Osteonics Corp.
TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dis... 2 04/25/2024 Howmedica Osteonics Corp.
TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dis... 2 04/25/2024 Howmedica Osteonics Corp.
TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip di... 2 04/25/2024 Howmedica Osteonics Corp.
TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip d... 2 04/25/2024 Howmedica Osteonics Corp.
TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip di... 2 04/25/2024 Howmedica Osteonics Corp.
TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dis... 2 04/25/2024 Howmedica Osteonics Corp.
TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip d... 2 04/25/2024 Howmedica Osteonics Corp.
TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip disl... 2 04/25/2024 Howmedica Osteonics Corp.
TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip di... 2 04/25/2024 Howmedica Osteonics Corp.
TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dis... 2 04/25/2024 Howmedica Osteonics Corp.
TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip d... 2 04/25/2024 Howmedica Osteonics Corp.
Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Versi... 2 04/24/2024 Electro Medical Systems SA
Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction ... 1 04/24/2024 ROUTE 92 MEDICAL INC
Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introdu... 1 04/24/2024 ROUTE 92 MEDICAL INC
Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interv... 1 04/24/2024 ROUTE 92 MEDICAL INC
Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction ... 1 04/24/2024 ROUTE 92 MEDICAL INC
Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of inte... 1 04/24/2024 ROUTE 92 MEDICAL INC
Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 ... 2 04/18/2024 Siemens Medical Solutions USA, Inc
Identity Imprint PS Tibial Tray Size 4: Lot 540287 2 04/17/2024 Conformis, Inc.
Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (so... 1 04/17/2024 Philips Respironics, Inc.
Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric ... 1 04/17/2024 Philips Respironics, Inc.
Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. 1 04/17/2024 Philips Respironics, Inc.
Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients... 1 04/17/2024 Philips Respironics, Inc.
Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.... 1 04/17/2024 Philips Respironics, Inc.
LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. ... 1 04/17/2024 Philips Respironics, Inc.
Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (s... 1 04/17/2024 Philips Respironics, Inc.
Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithi... 2 04/16/2024 Siemens Healthcare Diagnostics, Inc.
Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wa... 2 04/12/2024 Cook Incorporated
EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutrition directly into the... 2 04/11/2024 Boston Scientific Corporation
EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the ... 2 04/11/2024 Boston Scientific Corporation
EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into th... 2 04/11/2024 Boston Scientific Corporation
EndoVive 20Fr Push Safety PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach ... 2 04/11/2024 Boston Scientific Corporation
EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomac... 2 04/11/2024 Boston Scientific Corporation
ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35 2 04/04/2024 Abbott GmbH
Alinity i Anti-HCV Reagent Kit, List Number 08P0521 2 04/04/2024 Abbott GmbH
BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology ... 2 03/29/2024 Becton Dickinson & Co.
BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology ... 2 03/29/2024 Becton Dickinson & Co.
Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and f... 2 03/29/2024 Baxter Healthcare Corporation
Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to ... 2 03/28/2024 Boston Scientific Corporation
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050 1 03/26/2024 Boston Scientific Corporation
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS 1 03/19/2024 Smiths Medical ASD Inc.
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS 1 03/19/2024 Smiths Medical ASD Inc.
IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF S... 2 02/23/2024 Alphatec Spine, Inc.
VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF P... 1 02/23/2024 Ventec Life Systems, Inc.
These wipes are saturated with 0.65% bleach solution. These wipes are antimicrobial, disinfectant wi... 2 02/22/2024 MEDLINE INDUSTRIES, LP - Northfield
Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and mi... 2 02/22/2024 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and min... 2 02/22/2024 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and min... 2 02/22/2024 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray (Kit) A ... 2 02/16/2024 B. Braun Medical, Inc.
HENRY SCHEIN® CRITERION® ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281) 2 02/16/2024 AMD Medicom Inc.
PATTERSON® PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573) 2 02/16/2024 AMD Medicom Inc.
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC compo... 2 02/16/2024 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC c... 2 02/16/2024 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line ... 2 02/16/2024 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used i... 2 02/16/2024 Canon Medical System, USA, INC.
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC compo... 2 02/16/2024 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC c... 2 02/16/2024 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic m... 2 02/15/2024 BioFire Diagnostics, LLC
The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that i... 2 02/14/2024 Quidel Corporation
BD BBL Sensi Disc Cefixime - 5 ug®, used for semi-quantitative in vitro susceptibility testing. Cata... 2 02/08/2024 Becton Dickinson & Co.
BD BBL Sensi Disc Cefotaxime - 30 ug®, used for semi-quantitative in vitro susceptibility testing. C... 2 02/08/2024 Becton Dickinson & Co.
BD BBL Sensi Disc Cefpodoxime - 10 ug, used for semi-quantitative in vitro susceptibility testing. C... 2 02/08/2024 Becton Dickinson & Co.
BD BBL Sensi Disc Cefepime - 30 ug®, used for semi-quantitative in vitro susceptibility testing. Ca... 2 02/08/2024 Becton Dickinson & Co.
BD BBL Sensi Disc Cefaclor - 30 ug®, used for semi-quantitative in vitro susceptibility testing. Cat... 2 02/08/2024 Becton Dickinson & Co.
BD BBL Sensi Disc Aztreonam - 30 ug®, used for semi-quantitative in vitro susceptibility testing. C... 2 02/08/2024 Becton Dickinson & Co.
BD BBL Sensi Disc Azithromycin -15 ®g, Catalog Number 231682®used for semi-quantitative in vitro sus... 2 02/08/2024 Becton Dickinson & Co.
BD BBL Sensi Disc Augmentin - 3®g, Catalog Number 291270®used for semi-quantitative in vitro suscept... 2 02/08/2024 Becton Dickinson & Co.
BD BBL Sensi Disc Ampicillin with Sulbactam 10/10 ®g, Catalog Number 231660. Used for semi-quantit... 2 02/08/2024 Becton Dickinson & Co.
BD BBL Sensi Disc Ampicillin - 10 ®g, Catalog No. 230705 and 231264; 2 ®g, Catalog No. 231263. Used ... 2 02/08/2024 Becton Dickinson & Co.
Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ®g, Catalog No. 231628 and 231629.® These discs... 2 02/08/2024 Becton Dickinson & Co.
BD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro susceptibility testing. C... 2 02/08/2024 Becton Dickinson & Co.
BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Cat... 2 02/08/2024 Becton Dickinson & Co.
BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Ca... 2 02/08/2024 Becton Dickinson & Co.
BD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro susceptibility testing. Ca... 2 02/08/2024 Becton Dickinson & Co.
BD BBL Sensi Disc Cefuroxime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Cat... 2 02/08/2024 Becton Dickinson & Co.
BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing... 2 02/08/2024 Becton Dickinson & Co.
BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. C... 2 02/08/2024 Becton Dickinson & Co.
BD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro susceptibility testing.... 2 02/08/2024 Becton Dickinson & Co.
BD BBL Sensi Disc Doripenem- 15 ug, used for semi-quantitative in vitro susceptibility testing. Cata... 2 02/08/2024 Becton Dickinson & Co.
BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Cata... 2 02/08/2024 Becton Dickinson & Co.
BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catal... 2 02/08/2024 Becton Dickinson & Co.
BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Ca... 2 02/08/2024 Becton Dickinson & Co.
BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Cata... 2 02/08/2024 Becton Dickinson & Co.
BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro susceptibility testing. ... 2 02/08/2024 Becton Dickinson & Co.
BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Ca... 2 02/08/2024 Becton Dickinson & Co.
BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catal... 2 02/08/2024 Becton Dickinson & Co.
BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantitative in vitro susceptib... 2 02/08/2024 Becton Dickinson & Co.
BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalo... 2 02/08/2024 Becton Dickinson & Co.
BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vi... 2 02/08/2024 Becton Dickinson & Co.
Neurovascular embolization device. The Optima Coil System is a series specialized coils that are ins... 2 02/08/2024 BALT USA, LLC
Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subseq... 2 02/07/2024 Olympus Corporation of the Americas
Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems... 2 02/05/2024 CooperSurgical, Inc.
FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56 2 02/02/2024 G & H Wire Company
Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Num... 2 01/26/2024 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter with ENFit, 18Fr., 48in Long, REF EN004... 2 01/25/2024 C.R. Bard Inc
Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter with ENFit, 14Fr., 48in Long, REF EN004... 2 01/25/2024 C.R. Bard Inc
Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter with ENFit", 12Fr., 48in Long, REF EN00... 2 01/25/2024 C.R. Bard Inc
Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter with ENFit, 10Fr., 36in Long, REF EN004... 2 01/25/2024 C.R. Bard Inc
Bard® PreVent® Anti-Reflux Filter with ENFit, REF EN0046000 2 01/25/2024 C.R. Bard Inc
Bard® Nasogastric Sump Tube and PreVent® Anti-Reflux Filter and Lopez Valve® with ENFit, 12Fr., 48in... 2 01/25/2024 C.R. Bard Inc
Bard® Nasogastric Sump Tube and PreVent® Anti-Reflux Filter and Lopez Valve® with ENFit, 18Fr., 48in... 2 01/25/2024 C.R. Bard Inc
Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter with ENFit, 16Fr., 48in Long, REF EN004... 2 01/25/2024 C.R. Bard Inc
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS I... 2 01/19/2024 Ortho-Clinical Diagnostics, Inc.
INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040 2 01/17/2024 PHASE SCIENTIFIC INTERNATIONAL LIMITED
FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Ope... 2 01/16/2024 Abbott Diabetes Care, Inc.
ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abb... 2 01/09/2024 Abbott Laboratories
Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated c... 2 01/09/2024 Abbott Laboratories
Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated i... 2 01/09/2024 Abbott Laboratories
Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic an... 2 01/05/2024 WOM World Of Medicine AG
Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 28... 2 01/05/2024 Boston Scientific Corporation
Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807 2 01/04/2024 Beaver Visitec International, Inc.
KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as m... 2 01/03/2024 Keystone Industries
SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of... 3 01/02/2024 Randox Laboratories Ltd.
The System is designed as a modular system with components that include an Overhead Tube Suspension ... 2 12/14/2023 GE Hangwei Medical Systems, Co. LTD
The System is designed as a modular system with components that include an Overhead Tube Suspension ... 2 12/14/2023 GE Hangwei Medical Systems, Co. LTD
The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (R... 2 12/08/2023 BioReference Health, LLC
VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products E... 2 12/07/2023 Ortho-Clinical Diagnostics, INc.
vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequ... 2 12/05/2023 Vyaire Medical
vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequ... 2 12/05/2023 Vyaire Medical
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular ... 2 12/01/2023 BioFire Diagnostics, LLC
with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accesso... 2 11/27/2023 Breas Medical, Inc.
SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Nu... 2 11/25/2023 PATH
SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part N... 2 11/25/2023 PATH
SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 10009... 2 11/25/2023 PATH
AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide sucti... 2 11/21/2023 Avanos Medical, Inc.
AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in p... 2 11/16/2023 Beckman Coulter Biomedical Division
Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators. 2 11/07/2023 Percussionaire Corporation
LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitati... 2 11/03/2023 Magellan Diagnostics, Inc.
DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10 2 10/23/2023 Universal Meditech Inc.
Astral 100 and Astral 150 ventilators 1 10/23/2023 ResMed Ltd.
Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource PBDS Cat. POC... 2 10/10/2023 Cardinal Health 200, LLC
Meera Mobile Operating Table-to support and position the patient immediately before, during and afte... 2 10/04/2023 Getinge Usa Sales Inc
Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part N... 1 09/28/2023 Philips Respironics, Inc.
Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator 1 09/20/2023 Hamilton Medical, Inc.
Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator 1 09/20/2023 Hamilton Medical, Inc.
Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator 1 09/20/2023 Hamilton Medical, Inc.
Hamilton-MR1, REF: 161010, Intensive Care Ventilator 1 09/20/2023 Hamilton Medical, Inc.
Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator 1 09/20/2023 Hamilton Medical, Inc.
Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator 1 09/20/2023 Hamilton Medical, Inc.
Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Car... 2 09/19/2023 Abbott Medical
Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q Neutrino HF C... 2 09/19/2023 Abbott Medical
Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Info... 2 09/19/2023 Philips North America Llc
Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between... 2 09/12/2023 Keystone Industries
Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used ... 1 09/09/2023 Mallinckrodt Manufacturing LLC
Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-... 2 08/30/2023 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL chol... 2 08/29/2023 Siemens Healthcare Diagnostics, Inc.
Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total pro... 2 08/29/2023 Siemens Healthcare Diagnostics, Inc.
Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of ... 2 08/29/2023 Siemens Healthcare Diagnostics, Inc.
Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative determination of triglyceri... 2 08/29/2023 Siemens Healthcare Diagnostics, Inc.
LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Syst... 2 08/28/2023 Alphatec Spine, Inc.
Atellica® CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cho... 2 08/28/2023 Siemens Healthcare Diagnostics, Inc.
Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of... 2 08/28/2023 Siemens Healthcare Diagnostics, Inc.
Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL chole... 2 08/28/2023 Siemens Healthcare Diagnostics, Inc.
Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total b... 2 08/28/2023 Siemens Healthcare Diagnostics, Inc.
SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual pro... 2 08/25/2023 Stryker Corporation
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diag... 2 08/24/2023 Siemens Healthcare Diagnostics, Inc.
Carina Sub-Acute Care Ventilator 1 08/18/2023 Draeger Medical, Inc.
ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and int... 2 08/08/2023 Siemens Medical Solutions USA, Inc
ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and intervention... 2 08/08/2023 Siemens Medical Solutions USA, Inc
ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interv... 2 08/08/2023 Siemens Medical Solutions USA, Inc
ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone ... 2 08/03/2023 Materialise N.V.
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the fo... 2 08/03/2023 MEDLINE INDUSTRIES, LP - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the fo... 2 08/03/2023 MEDLINE INDUSTRIES, LP - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the fo... 2 08/03/2023 MEDLINE INDUSTRIES, LP - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the fo... 2 08/03/2023 MEDLINE INDUSTRIES, LP - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the fo... 2 08/03/2023 MEDLINE INDUSTRIES, LP - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the fo... 2 08/03/2023 MEDLINE INDUSTRIES, LP - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the fo... 2 08/03/2023 MEDLINE INDUSTRIES, LP - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the fo... 2 08/03/2023 MEDLINE INDUSTRIES, LP - Northfield
Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-Int... 2 07/28/2023 Olympus Corporation of the Americas
Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm ... 2 07/28/2023 Olympus Corporation of the Americas
Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga Intended for... 2 07/28/2023 Olympus Corporation of the Americas
Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex Needle, 12mm L, 1.8mm OD-I... 2 07/28/2023 Olympus Corporation of the Americas
Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm... 2 07/28/2023 Olympus Corporation of the Americas
Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD, Serrated Cup-Intended ... 2 07/28/2023 Olympus Corporation of the Americas
Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval Cup-Intended for... 2 07/28/2023 Olympus Corporation of the Americas
Always-On Tip Tracked Instruments (SPiN Drive® instruments) Brush, 15mm L, 1.8mm OD Intended for us... 2 07/28/2023 Olympus Corporation of the Americas
QIAstat-Dx® Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucl... 2 07/21/2023 Qiagen GmbH
HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pres... 1 07/21/2023 Hamilton Medical, Inc.
HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and... 1 07/21/2023 Hamilton Medical, Inc.
HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory... 1 07/21/2023 Hamilton Medical, Inc.
HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support t... 1 07/21/2023 Hamilton Medical, Inc.
VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For ... 3 07/21/2023 Ortho-Clinical Diagnostics, Inc.
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VAD/PICC... 2 07/20/2023 MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) EP PACER P... 2 07/20/2023 MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CH... 2 07/20/2023 MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPH... 2 07/20/2023 MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) SILVER CRO... 2 07/20/2023 MEDLINE INDUSTRIES, LP - Northfield
COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells 2 07/12/2023 Beckman Coulter, Inc.
VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products... 2 07/11/2023 Ortho-Clinical Diagnostics
Oxylog 3000 Plus emergency and transport ventilator 1 07/08/2023 Draeger Medical, Inc.
EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP I... 2 06/30/2023 Phadia US Inc
Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies ... 2 06/30/2023 Phadia US Inc
Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by d... 2 06/29/2023 DRE Medical Group Inc
bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator 2 06/15/2023 Vyaire Medical
bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator 2 06/15/2023 Vyaire Medical
Alinity i Anti-TPO Reagent Kit, List Number 09P3521 3 06/08/2023 Abbott Ireland Limited
Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ... 1 06/08/2023 BearCare, Inc.
BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended... 2 06/02/2023 Becton Dickinson & Co.
Trilogy Evo Universal Ventilator, Model Number DS2000X11B 1 06/02/2023 Philips Respironics, Inc.
The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays ... 2 06/02/2023 BioReference Health, LLC
VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Dat... 2 05/30/2023 Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glyca... 2 05/24/2023 Ortho-Clinical Diagnostics, Inc.
Set2Go Ventilation 12 (A), MP07968 1 05/17/2023 Draeger Medical, Inc.
PDS® Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME.... 2 05/10/2023 Ethicon, Inc.
VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qual... 2 05/04/2023 Ortho-Clinical Diagnostics, Inc.
VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitat... 2 05/04/2023 Ortho-Clinical Diagnostics, Inc.
VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitati... 2 05/04/2023 Ortho-Clinical Diagnostics, Inc.
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.
ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography sys... 2 05/02/2023 Siemens Medical Solutions USA, Inc
ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventi... 2 04/27/2023 Siemens Medical Solutions USA, Inc
MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device 2 04/19/2023 Medacta Usa Inc
VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the A... 2 04/18/2023 Ortho-Clinical Diagnostics, Inc.
BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD 2 04/12/2023 Bio-Rad Laboratories, Inc.
BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD 2 04/12/2023 Bio-Rad Laboratories, Inc.
Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, ... 1 04/03/2023 Philips Respironics, Inc.
Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200... 1 04/03/2023 Philips Respironics, Inc.
Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B 1 04/03/2023 Philips Respironics, Inc.
Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305 2 04/01/2023 Fujifilm Irvine Scientific, Inc.
Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative meas... 2 03/15/2023 Siemens Healthcare Diagnostics, Inc.
BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human ci... 2 03/06/2023 Aniara Diagnostica LLC
stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device ... 2 03/01/2023 Stryker GmbH
NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and... 1 02/24/2023 Draeger Medical, Inc.
Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of individuals 1 02/24/2023 Baxter Healthcare Corporation
Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the c... 1 02/24/2023 Baxter Healthcare Corporation
Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care ... 1 02/24/2023 Baxter Healthcare Corporation
Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the ca... 1 02/24/2023 Baxter Healthcare Corporation
Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of fo... 2 02/21/2023 Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the quantitative determinatio... 2 02/21/2023 Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative determination of ... 2 02/21/2023 Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determination of f... 2 02/21/2023 Siemens Healthcare Diagnostics, Inc.
Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of fo... 2 02/21/2023 Siemens Healthcare Diagnostics, Inc.
Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination ... 2 02/21/2023 Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for th... 2 02/17/2023 Siemens Healthcare Diagnostics, Inc.
iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE 2 02/13/2023 Conformis, Inc.
Identity Shoulder System Resection Planer 35mm Resection Planer 2 02/06/2023 Zimmer, Inc.
Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 CDS b. C-SECTION CDS c... 2 02/06/2023 MEDLINE INDUSTRIES, LP - Northfield
Mammotome MammoStar Biopsy Site Identified, REF STAR1401 2 01/30/2023 Carbon Medical Technologies, Inc.
Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) ... 1 01/27/2023 Universal Meditech Inc.
CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760 2 01/25/2023 MEDLINE INDUSTRIES, LP - Northfield
IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyz... 2 01/11/2023 Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Systems Analyz... 2 01/11/2023 Siemens Healthcare Diagnostics, Inc.
Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA105... 1 01/06/2023 Philips Respironics, Inc.
Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA... 1 01/06/2023 Philips Respironics, Inc.
Philips Garbin Ventilator, Model Number 1058180B 1 01/06/2023 Philips Respironics, Inc.
VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of i... 2 01/04/2023 Ortho-Clinical Diagnostics, Inc.
Vivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN;... 2 12/22/2022 GE Medical Systems, LLC
Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN... 2 12/22/2022 GE Medical Systems, LLC
Vivid q N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal... 2 12/22/2022 GE Medical Systems, LLC
Vivid i N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/O... 2 12/22/2022 GE Medical Systems, LLC
Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN... 2 12/22/2022 GE Medical Systems, LLC
Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140... 2 12/22/2022 GE Medical Systems, LLC
Vivid S6 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/... 2 12/22/2022 GE Medical Systems, LLC
Vivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/... 2 12/22/2022 GE Medical Systems, LLC
Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in ... 3 12/20/2022 Howmedica Osteonics Corp.
Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714 3 12/19/2022 Young Dental Manufacturing I, LLC
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (S... 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 (600T)- US. Siemens Material Numb... 2 12/15/2022 Siemens Healthcare Diagnostics, Inc.
Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST 1 12/08/2022 Remel Inc
Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST 1 12/08/2022 Remel Inc
Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST 1 12/08/2022 Remel Inc
Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST 1 12/08/2022 Remel Inc
Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST 1 12/08/2022 Remel Inc
Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST 1 12/08/2022 Remel Inc
Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST 1 12/08/2022 Remel Inc
Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST 1 12/08/2022 Remel Inc
Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST 1 12/08/2022 Remel Inc
IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and I... 2 12/02/2022 Siemens Healthcare Diagnostics, Inc.
GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY PNEUMONITIS t... 2 11/30/2022 Greer Laboratories, Inc.
GREER DIA - KIT ANTIGEN M. FAENI, 2.0mL 20 MG/ML, Analyte Specific Reagent, Item: K62, HYPERSENSITIV... 2 11/30/2022 Greer Laboratories, Inc.
PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong Soft Catheter, Closed T... 2 11/23/2022 Pajunk Medical Systems, L.P.
Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implem... 2 11/21/2022 Smiths Medical ASD Inc.
BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and suscepti... 2 11/14/2022 Becton Dickinson & Co.
Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the... 2 11/11/2022 Spectranetics Corporation
VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic ... 2 11/10/2022 Ortho-Clinical Diagnostics, Inc.
Disc Preparation instruments contained in the following products: CI-11050-08102515 Longer IdentiT... 2 11/08/2022 Alphatec Spine, Inc.
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare Bed Rev. A-J... 1 10/31/2022 Baxter Healthcare Corporation
Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for VersaCare Bed Rev. K, P... 1 10/31/2022 Baxter Healthcare Corporation
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product... 1 10/31/2022 Baxter Healthcare Corporation
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed, Product... 1 10/31/2022 Baxter Healthcare Corporation
Hillrom Centrella Hospital Bed with WatchCare Incontinence Management System, Product code/Part numb... 1 10/31/2022 Baxter Healthcare Corporation
sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuo... 2 10/28/2022 SenTec AG
LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The L... 3 10/26/2022 LumiraDx
ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000 2 10/21/2022 Siemens Medical Solutions USA, Inc
DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001 2 10/18/2022 Synthes (USA) Products LLC
SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910 2 10/18/2022 Synthes (USA) Products LLC
SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512 2 10/18/2022 Synthes (USA) Products LLC
SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes S... 2 10/18/2022 Synthes (USA) Products LLC
N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material N... 2 10/14/2022 SIEMENS HEALTHCARE DIAGNOSTICS INC
N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Materi... 2 10/14/2022 SIEMENS HEALTHCARE DIAGNOSTICS INC
Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002 2 10/12/2022 LUMINOSTICS, INC dba CLIP HEALTH
Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing cont... 2 10/12/2022 Baxter Healthcare Corporation
Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and... 2 10/12/2022 Baxter Healthcare Corporation
Prismaflex HF Set: HF1000 (product code 107140), HF1400 (product code 107142). For use in providin... 2 10/12/2022 Baxter Healthcare Corporation
Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107... 2 10/12/2022 Baxter Healthcare Corporation
Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and ren... 2 10/12/2022 Baxter Healthcare Corporation
Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to prov... 2 10/06/2022 B Braun Medical Inc
Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001 2 10/06/2022 Synthes (USA) Products LLC
Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 T... 2 09/28/2022 Cook Incorporated
Puritan Bennett 560 Ventilator, PB560, CFN 4096600 2 09/22/2022 Covidien Llc
The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti H... 2 09/19/2022 Randox Laboratories Ltd.
Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endos... 2 09/19/2022 Diversatek Healthcare
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35-180 ORDER NUMBER (GPN... 2 09/09/2022 Cook Incorporated
Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for ... 1 09/09/2022 Philips Respironics, Inc.
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBE... 2 09/09/2022 Cook Incorporated
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMB... 2 09/09/2022 Cook Incorporated
Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructiv... 1 09/09/2022 Philips Respironics, Inc.
Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructiv... 1 09/09/2022 Philips Respironics, Inc.
Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstr... 1 09/09/2022 Philips Respironics, Inc.
Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with ob... 1 09/09/2022 Philips Respironics, Inc.
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G... 2 09/09/2022 Cook Incorporated
Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation... 1 09/09/2022 Philips Respironics, Inc.
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) ... 2 09/09/2022 Cook Incorporated
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):... 2 09/09/2022 Cook Incorporated
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER ... 2 09/09/2022 Cook Incorporated
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER... 2 09/09/2022 Cook Incorporated
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-80 ORDER NUMBER ... 2 09/09/2022 Cook Incorporated
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-150 ORDER NUMB... 2 09/09/2022 Cook Incorporated
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER NUMBE... 2 09/09/2022 Cook Incorporated
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBE... 2 09/09/2022 Cook Incorporated
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-80 ORDER NUMBER... 2 09/09/2022 Cook Incorporated
INFX-8000V. For radiographic and fluoroscopic studies and intervention. 2 09/02/2022 Canon Medical System, USA, INC.
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programmin... 2 09/02/2022 Boston Scientific Corporation
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with B... 2 09/02/2022 Boston Scientific Corporation
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with B... 2 09/02/2022 Boston Scientific Corporation
Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measu... 2 08/29/2022 Siemens Healthcare Diagnostics, Inc.
FISHER SCIENTIFIC Sure-Vue PIPETTE, RPR DISPENSING (500/PK) Catalog # 23038015 2 08/26/2022 Mckesson Medical-Surgical Inc. Corporate Office
FISHER SCIENTIFIC Aseptic Control® LUBRICATING JELLY PAP TEST 4OZ(12/PK) Catalog #22998006 2 08/26/2022 Mckesson Medical-Surgical Inc. Corporate Office
FISHER SCIENTIFIC Fisherbrand SWAB, ROUND BOTTOM CLR (50/PK)FSHSCI Catalog # 1490712 2 08/26/2022 Mckesson Medical-Surgical Inc. Corporate Office
Ethicon SURGIFLO Hemostatic Matrix Kit with Thrombin (6/CS) Ref: 2994 Mfg: FERROSAN MEDICAL DE... 2 08/26/2022 Mckesson Medical-Surgical Inc. Corporate Office
FISHER SCIENTIFIC Fisherbrand SWAB TRANS STUARTS DBL 50BX Catalog #1490721 2 08/26/2022 Mckesson Medical-Surgical Inc. Corporate Office
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440 2 08/25/2022 Boston Scientific Corporation
ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208 2 08/24/2022 Materialise USA LLC
Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, mo... 2 08/24/2022 Getinge Usa Sales Inc
Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator ... 1 08/22/2022 Getinge Usa Sales Inc
HAMILTON-C6 Intensive Care Ventilator, REF: 160021 1 08/19/2022 Hamilton Medical AG
AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material... 3 08/18/2022 Siemens Medical Solutions USA, Inc
Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iro... 2 08/04/2022 Siemens Healthcare Diagnostics, Inc.
SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid... 1 07/29/2022 North American Diagnostics
LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control 2 07/22/2022 LumiraDx
LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip 2 07/22/2022 LumiraDx
SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for coun... 2 07/22/2022 Stryker Instruments Div. of Stryker Corporation
Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma.... 2 07/20/2022 Randox Laboratories Ltd.
Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic ca... 2 07/20/2022 Siemens Medical Solutions USA, Inc
Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemo... 2 07/20/2022 Siemens Medical Solutions USA, Inc
Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determin... 3 07/15/2022 R & D Systems, Inc.
Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Acc... 3 07/14/2022 Agilent Technologies, Inc.
Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the car... 2 07/13/2022 Breas Medical, Inc.
Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS® ECi/ECiQ/3600 Immunodiag... 2 07/12/2022 Ortho-Clinical Diagnostics, Inc.
epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of ... 2 07/12/2022 Siemens Healthcare Diagnostics Inc
Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopi... 2 07/07/2022 Siemens Medical Solutions USA, Inc
Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels i... 2 07/06/2022 Siemens Healthcare Diagnostics, Inc.
Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels ... 2 07/06/2022 Siemens Healthcare Diagnostics, Inc.
Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600 2 07/06/2022 Siemens Medical Solutions USA, Inc
Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A 2 06/30/2022 Skytron, Div. The KMW Group, Inc
Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000 2 06/27/2022 Siemens Medical Solutions USA, Inc
Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire... 1 06/23/2022 Getinge Usa Sales Inc
Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entir... 1 06/23/2022 Getinge Usa Sales Inc
Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and int... 2 06/07/2022 Siemens Medical Solutions USA, Inc
Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interv... 2 06/07/2022 Siemens Medical Solutions USA, Inc
Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b... 1 06/06/2022 GE Healthcare, LLC
Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr®om C... 1 06/06/2022 GE Healthcare, LLC
BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which... 2 06/01/2022 Becton, Dickinson and Company, BD Biosciences
BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the Anti-Kappa antibody, whic... 2 06/01/2022 Becton, Dickinson and Company, BD Biosciences
In-Line ventilator adaptor 1 05/30/2022 Baxter Healthcare Corporation
In-Line ventilator adaptor 1 05/30/2022 Baxter Healthcare Corporation
I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822 2 05/28/2022 Busse Hospital Disposables, Inc.
Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenie... 2 05/17/2022 Windstone Medical Packaging, Inc.
Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test 1 05/12/2022 Woodside Acquisitions Inc.
Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test 1 05/12/2022 Woodside Acquisitions Inc.
ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collecti... 2 05/11/2022 PROTERIXBIO
Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. F... 2 05/06/2022 Philips North America Llc
Diagnostic Kit SARS-cCo V Antigen Rapid Test 2 05/06/2022 USA Medical, LLC
Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test 1 05/03/2022 SML Distribution, LLC
ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determinat... 2 04/29/2022 Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determinat... 2 04/29/2022 Siemens Healthcare Diagnostics, Inc.
Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determ... 2 04/29/2022 Siemens Healthcare Diagnostics, Inc.
Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determinatio... 2 04/29/2022 Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative dete... 2 04/29/2022 Siemens Healthcare Diagnostics, Inc.
Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determinatio... 2 04/29/2022 Siemens Healthcare Diagnostics, Inc.
Puritan Bennett 980 Series Ventilator 1 04/25/2022 Medtronic formerly Covidien
The Sight OLO device is a computer vision based platform for blood analysis. The platform combines ... 2 04/21/2022 SIGHT DIAGNOSTICS LTD
Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended... 2 04/21/2022 Siemens Medical Solutions USA, Inc
Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). In... 2 04/21/2022 Siemens Medical Solutions USA, Inc
Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM).... 2 04/21/2022 Siemens Medical Solutions USA, Inc
Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276) 1 04/18/2022 Respironics California, LLC
Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 10536... 1 04/18/2022 Respironics California, LLC
Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outs... 1 04/18/2022 Respironics California, LLC
Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked 2 04/15/2022 Acon Biotech (Hangzhou) Co., Ltd.
Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384 2 04/15/2022 Breas Medical, Inc.
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101 2 04/08/2022 Conformis, Inc.
First SIGN SARS-CoV-2 Antigen Test 2 04/07/2022 WHPM Inc.
ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are fo... 2 04/07/2022 Abbott Laboratories
Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile... 2 04/07/2022 Brius Technologies Inc.
Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom... 2 04/07/2022 Brius Technologies Inc.
Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , R... 2 04/07/2022 Brius Technologies 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
Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal pati... 2 04/04/2022 Draeger Medical, Inc.
Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pedia... 2 04/04/2022 Draeger Medical, Inc.
Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive C... 2 03/31/2022 Microbiologics Inc
MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, M... 2 03/31/2022 Medtronic MiniMed
Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 ... 2 03/28/2022 Siemens Healthcare Diagnostics, Inc.
BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [AL... 2 03/18/2022 Biomet, Inc.
BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged... 2 03/18/2022 Biomet, Inc.
BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item # 1318-12-126, DVR C... 2 03/18/2022 Biomet, Inc.
BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [I... 2 03/18/2022 Biomet, Inc.
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is inten... 1 03/18/2022 Philips Respironics, Inc.
STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immu... 1 03/16/2022 SD Biosensor, Inc.
Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity... 2 03/11/2022 Abbott Laboratories, Inc
Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114... 1 03/10/2022 Lusys Laboratories, Inc.
LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test) 1 03/10/2022 Lusys Laboratories, Inc.
COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111 1 03/10/2022 Lusys Laboratories, Inc.
Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format 2 03/04/2022 Remel Inc
Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without a... 2 03/04/2022 Philips North America Llc
Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System produc... 2 03/04/2022 Philips North America Llc
Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile 2 02/28/2022 ROi CPS LLC
Philips Respironics V60 Plus Ventilator Part Number 1138747 1 02/25/2022 Respironics California, LLC
Philips Respironics V60 Ventilator Part Number 1053617 1 02/25/2022 Respironics California, LLC
meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The ImmunoCard S... 2 02/24/2022 MEDLINE INDUSTRIES, LP - Northfield
bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. Th... 1 02/16/2022 Vyaire Medical
E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit 1 02/09/2022 E25Bio, Inc.
QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel (Live Culture).... 2 02/08/2022 Microbiologics Inc
CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal ... 2 01/31/2022 Immuno-Mycologics, Inc
ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60 1 01/29/2022 Empowered Diagnostics LLC
CovClear COVID-19 Rapid Antigen Test, ATG 900-031 1 01/29/2022 Empowered Diagnostics LLC
API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized syste... 2 01/25/2022 Biomerieux Inc
Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator ... 1 01/22/2022 Philips Respironics, Inc.
Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ... 1 01/22/2022 Philips Respironics, Inc.
1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: ... 2 01/14/2022 Siemens Medical Solutions USA, Inc
Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration st... 2 01/10/2022 Philips North America Llc
Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluorosco... 2 01/10/2022 Philips North America Llc
Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in prep... 2 01/06/2022 Howmedica Osteonics Corp.
Atellica CH ®2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determi... 2 12/29/2021 Siemens Healthcare Diagnostics, Inc.
RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/pac... 2 12/27/2021 Biomerieux Inc
FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test 2 12/27/2021 Migo Trading LLC
Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovasc... 2 12/22/2021 Philips North America Llc
Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator 2 12/16/2021 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72 2 12/16/2021 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or c... 2 12/15/2021 Clark Laboratories, Inc.
Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) an... 2 12/15/2021 Boston Scientific Corporation
Puritan Bennett 980 Series Ventilator, 980X1ENDIUU 1 12/09/2021 Covidien, LP
Puritan Bennett 980 Series Ventilator, 980X1ENNISB 1 12/09/2021 Covidien, LP
Puritan Bennett 980 Series Ventilator, 980X1JADIJJ 1 12/09/2021 Covidien, LP
Puritan Bennett 980 Series Ventilator, 980X1PLDIPC 1 12/09/2021 Covidien, LP
Puritan Bennett 980 Series Ventilator, 980X2ESDIEC 1 12/09/2021 Covidien, LP
Puritan Bennett 980 Series Ventilator, 980X3ENDIUU 1 12/09/2021 Covidien, LP
Puritan Bennett 980 Series Ventilator, 980X3JADIJJ 1 12/09/2021 Covidien, LP
Puritan Bennett 980 Series Ventilator, 980X1ENDIPC 1 12/09/2021 Covidien, LP
Puritan Bennett 980 Series Ventilator,980X1ENAIQC 1 12/09/2021 Covidien, LP
Puritan Bennett 980 Series Ventilator, 980U3ESDIUU 1 12/09/2021 Covidien, LP
Puritan Bennett 980 Series Ventilator, 980U1ESDIUC 1 12/09/2021 Covidien, LP
Puritan Bennett 980 Series Ventilator, 980U1ENASAA 1 12/09/2021 Covidien, LP
Puritan Bennett 980 Series Ventilator, 980S3ENDICU 1 12/09/2021 Covidien, LP
Puritan Bennett 980 Series Ventilator, 980S1ENDICU 1 12/09/2021 Covidien, LP
Puritan Bennett 980 Series Ventilator, 980A1ENNISB 1 12/09/2021 Covidien, LP
Puritan Bennett 980 Series Ventilator, 980A3ENNISB 1 12/09/2021 Covidien, LP
O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model prepar... 2 12/06/2021 Orchestrate Orthodontic Technologies, Inc.
Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device ... 2 12/03/2021 Northgate Technologies, Inc.
BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blo... 2 11/30/2021 BioFire Diagnostics, LLC
BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System- Dual port -... 2 11/24/2021 Becton Dickinson Infusion Therapy Systems Inc.
Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic im... 2 11/24/2021 Siemens Medical Solutions USA, Inc
Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic i... 2 11/24/2021 Siemens Medical Solutions USA, Inc
Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic i... 2 11/24/2021 Siemens Medical Solutions USA, Inc
Artis Q.zen floor with software VD12-angiography systems developed for single and biplane diagnostic... 2 11/24/2021 Siemens Medical Solutions USA, Inc
Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnost... 2 11/24/2021 Siemens Medical Solutions USA, Inc
Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnos... 2 11/24/2021 Siemens Medical Solutions USA, Inc
Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic... 2 11/24/2021 Siemens Medical Solutions USA, Inc
Artis zee multi-purpose with software VD12-angiography systems developed for single and biplane diag... 2 11/24/2021 Siemens Medical Solutions USA, Inc
Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnosti... 2 11/24/2021 Siemens Medical Solutions USA, Inc
Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic i... 2 11/24/2021 Siemens Medical Solutions USA, Inc
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System Number: 8824... 2 11/24/2021 Philips North America Llc
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GXL 16 Slice System Numbe... 2 11/24/2021 Philips North America Llc
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System Number: 88... 2 11/24/2021 Philips North America Llc
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ACQSIM CT System Number... 2 11/24/2021 Philips North America Llc
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT System ... 2 11/24/2021 Philips North America Llc
Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test syst... 2 11/18/2021 Roche Diagnostics Operations, Inc.
VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring ... 3 11/17/2021 Ortho-Clinical Diagnostics, Inc.
BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphili... 2 11/16/2021 Bio-Rad Laboratories, Inc.
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.
Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 7220... 2 11/09/2021 Philips North America Llc
ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866 2 11/03/2021 Siemens Healthcare Diagnostics, Inc
Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861 2 11/03/2021 Siemens Healthcare Diagnostics, Inc
Pneupac paraPac plus 300 ventilator kit, REF P300NGB 3 10/22/2021 Smiths Medical ASD Inc.
HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory profe... 2 10/19/2021 Instrumentation Laboratory
HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfraction... 2 10/19/2021 Instrumentation Laboratory
HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfraction... 2 10/19/2021 Instrumentation Laboratory
Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, ster... 2 10/19/2021 Bard Peripheral Vascular Inc
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monito... 2 10/15/2021 Ortho Clinical Diagnostics Inc
Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pe... 2 10/14/2021 Draeger Medical, Inc.
Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neona... 2 10/14/2021 Draeger Medical, Inc.
smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number DPSHC0081 2 10/13/2021 Smiths Medical ASD Inc.
smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091 2 10/13/2021 Smiths Medical ASD Inc.
BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375 2 09/16/2021 Leica Microsystems, Inc.
The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular a... 2 09/14/2021 Philips North America Llc

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