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U.S. Department of Health and Human Services

Medical Device Recalls

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RadiaLux Lighted Retractor (Pink), REF: 50-101-1 2 01/12/2023 Medtronic Navigation, Inc.
Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare. 2 01/11/2023 Stradis Healthcare
Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile 2 01/11/2023 Stradis Healthcare
Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis Healthcare... 2 01/11/2023 Stradis Healthcare
Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog nu... 2 01/06/2023 Bayer Medical Care, Inc.
VIDAS CLINICAL VIDAS ESTRADIOL II 60 TESTS, CATALOG 30431-01 2 01/04/2023 Biomerieux Inc
Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714 3 12/19/2022 Young Dental Manufacturing I, LLC
Oncentra Brachy radiation therapy planning system software. 2 12/15/2022 Elekta, Inc.
STRADIS HEALTHCARE, Surgical Pk, Item No.40510TWS, oral surgery tray 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Surg, Item No.40551TMS. oral surgery tray 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Surgical Pk, Item No.40649ECS, dental 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, pack Item No.40788SMS, oral surgery tray 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Implants, Item No.41015NSI, dental tray 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, DENTAL CUSTOM PACK, Item No.41137TDS, 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Custom Pack, Item No.41213ATCP, dental 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, COTTON APPLICATOR 3" Item No.505-010, 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, SAFETY PINS, SMALL 1" Item No.515-001 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Introducer Kit Micro, Item No.525-038, cardiovascular 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, PROBE COVER W/GEL PACK, Item No.525-071, general surgery tray 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, CURVED TIP SYRINGE, Item No.60060GCTS, 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Lipo, Item No.681-254, 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001, 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Thoracic Phleb, Item No.682-1228, 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Ablation Pack, Item No.682-130, 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Phleb, Item No.682-1425, 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Vasc Vein, Item No.682-1583, 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Surgery PK, Item No.682-1728, 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Vein, Item No.682-1732, 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Angioplasty, Item No.682-1937, 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Vein RF Pack, Item No.682-1942NL1, 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1, 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Medical Vein, Item No.682-330, 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1, 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
www.StradisHealthcare.com, Endovenous Pack, Item No.682-494, 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Endo Pack, Item No.682-509, 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Vein, Item No.682-577, 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Varicosity Basic Pack, Item No.682-947, 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Femoral, Vasc, Item No.686-142, 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Angio Pack, Item No.686-199, 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Breast, Item No.693-276, 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, TIP, SURGE-O-VAC .125" GREEN, Item No.SS077225, 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Surg Pack, Item No.40450SMS, dental 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Perio Surgery, Item No. 20177RPSS 2 12/14/2022 Stradis Medical, LLC dba Stradis Healthcare
ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Num... 2 12/09/2022 Siemens Medical Solutions USA, Inc
Philips Upgrade to MR 7700 System, Model Number 782130 2 12/08/2022 Philips North America Llc
CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 8" (20.3CM) DEEP STERRAD CO... 2 11/11/2022 Carefusion 2200 Inc
CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 4" (10CM) DEEP STERRAD CO... 2 11/11/2022 Carefusion 2200 Inc
CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 5" (12.7CM) DEEP STERRAD ... 2 11/11/2022 Carefusion 2200 Inc
CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 6" (15.2CM) DEEP STERRAD ... 2 11/11/2022 Carefusion 2200 Inc
CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 7" (17.8CM) DEEP, PERFORA... 2 11/11/2022 Carefusion 2200 Inc
CareFusion V.Mueller GENESIS SMALL, SHALLOW CONT. 21 X 7" (53.3 X 17.8CM) 3" (7.6CM) DEEP STERRAD CO... 2 11/11/2022 Carefusion 2200 Inc
CareFusion V.Mueller GENESIS SMALL CONTAINER 21 X 7" (53.3 X 17.8CM) 5-1/2" (14CM) DEEP STERRAD COMP... 2 11/11/2022 Carefusion 2200 Inc
CareFusion V.Mueller GENESIS LARGE, SHALLOW CONT. 28 X 11" (71.1 X 27.9CM) 3" (7.6CM) DEEP, PERFORAT... 2 11/11/2022 Carefusion 2200 Inc
CareFusion V.Mueller GENESIS LARGE, CONTAINER 28 X 11" (71.1 X 27.9CM) 6" (15.2CM) DEEP, PERFORATED ... 2 11/11/2022 Carefusion 2200 Inc
CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP STERRAD CO... 2 11/11/2022 Carefusion 2200 Inc
CareFusion V.Mueller GENESIS QTR-LENGTH CONTAINER 12 X 8" (30.3X20.3CM) 4" (10.2CM) DEEP STERRAD COM... 2 11/11/2022 Carefusion 2200 Inc
CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 4" (10CM) DEEP STERRAD COM... 2 11/11/2022 Carefusion 2200 Inc
CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 5" (12.7CM) DEEP STERRAD C... 2 11/11/2022 Carefusion 2200 Inc
CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 6" (15.2CM) DEEP STERRAD C... 2 11/11/2022 Carefusion 2200 Inc
CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 4" (10CM) DEEP STERRAD COMP... 2 11/11/2022 Carefusion 2200 Inc
CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 5" (12.7CM) DEEP STERRAD CO... 2 11/11/2022 Carefusion 2200 Inc
CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 6" (15.2CM) DEEP STERRAD CO... 2 11/11/2022 Carefusion 2200 Inc
MEDLINE RADIOLOGY PROCEDURE PACK, REF DYNJ67150A. Convenience kit used in medical procedures. 2 11/01/2022 MEDLINE INDUSTRIES, LP - Northfield
LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The L... 3 10/26/2022 LumiraDx
stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus R... 2 10/04/2022 Wright Medical Technology, Inc.
stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus... 2 10/04/2022 Wright Medical Technology, Inc.
The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft... 2 09/30/2022 Hologic, Inc
Skin markers: a. IZI MEDICAL PRODUCTS LLC Multi-Modality Markers SKIN MARKER RADIO 1.5MM 50BX Cat... 3 09/26/2022 Mckesson Medical-Surgical Inc. Corporate Office
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237. 2 09/15/2022 Philips Medical Systems (Cleveland) Inc
ZAP-X Radiosurgery System 2 09/14/2022 Zap Surgical Systems
Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE P... 2 09/07/2022 ICU Medical, Inc.
Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock Bag Spike/CL-10; ChemoL... 2 09/07/2022 ICU Medical, Inc.
INFX-8000V. For radiographic and fluoroscopic studies and intervention. 2 09/02/2022 Canon Medical System, USA, INC.
AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material... 3 08/18/2022 Siemens Medical Solutions USA, Inc
CURAD FIRST AID KIT, SKU 999037 2 08/17/2022 Family Dollar Stores, Llc.
CURAD STRNG WATRPRF STRIP 1IN 20CT, SKU 2 08/17/2022 Family Dollar Stores, Llc.
LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip 2 07/22/2022 LumiraDx
LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control 2 07/22/2022 LumiraDx
Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemo... 2 07/20/2022 Siemens Medical Solutions USA, Inc
Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic ca... 2 07/20/2022 Siemens Medical Solutions USA, Inc
RayStation 9B SP1. For radiation treatment planning. 2 07/19/2022 RAYSEARCH LABORATORIES AB
X80 RADiant Photoelectric Therapy System 2 07/19/2022 Xstrahl Limited
ProxiDiagnost N90. radiography and fluoroscopy system 2 07/12/2022 Philips Medical Systems DMC GmbH
DigitalDiagnost C90 High Performance. radiography and fluoroscopy system 2 07/12/2022 Philips Medical Systems DMC GmbH
DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system 2 07/12/2022 Philips Medical Systems DMC GmbH
DigitalDiagnost 4 High Performance. radiography and fluoroscopy system 2 07/12/2022 Philips Medical Systems DMC GmbH
DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system 2 07/12/2022 Philips Medical Systems DMC GmbH
Omnera 400A Digital Radiographic System 2 07/05/2022 Arcoma AB
Omnera 400T Digital Radiographic System 2 07/05/2022 Arcoma AB
DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of... 2 06/28/2022 CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD.
Centricity Radiology RA600 2 06/03/2022 GE Healthcare, LLC
The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during th... 2 05/27/2022 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patien... 2 05/27/2022 Ion Beam Applications S.A.
Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin... 2 05/19/2022 Radiometer Medical ApS
Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial h... 2 05/12/2022 Synthes (USA) Products LLC
Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determinatio... 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.
Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determ... 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.
ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative dete... 2 04/29/2022 Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determinat... 2 04/29/2022 Siemens Healthcare Diagnostics, Inc.
SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior rectal wall... 2 04/25/2022 Boston Scientific Corporation
SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anter... 2 04/25/2022 Boston Scientific Corporation
syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running... 2 04/22/2022 Siemens Medical Solutions USA, Inc
syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Sim Model Number 11061660. Running... 2 04/22/2022 Siemens Medical Solutions USA, Inc
syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Model Number 11061670. R... 2 04/22/2022 Siemens Medical Solutions USA, Inc
syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on s... 2 04/22/2022 Siemens Medical Solutions USA, Inc
Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001;... 2 04/20/2022 Medtronic Xomed, Inc.
ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1 2 04/14/2022 Varian Medical Systems Imaging Laboratory GmbH
Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system 2 03/30/2022 Siemens Medical Solutions USA, Inc
ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patie... 2 03/10/2022 Ion Beam Applications S.A.
RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Ver... 2 03/08/2022 RAYSEARCH LABORATORIES AB
The DARCO® Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatib... 2 02/25/2022 Wright Medical Technology, Inc.
The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten... 2 02/22/2022 BALT USA, LLC
Veradius Unity, Model #718132 2 02/17/2022 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument av... 2 02/10/2022 Synthes (USA) Products LLC
CURAD REUSABLE GEL HOT/COLD PACK 2 02/09/2022 MEDLINE INDUSTRIES, LP - Northfield
1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: ... 2 01/14/2022 Siemens Medical Solutions USA, Inc
RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics... 2 01/10/2022 Reflexion Medical, Inc.
Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAM... 2 12/29/2021 Karl Storz Endoscopy
ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radi... 2 12/29/2021 Siemens Medical Solutions USA, Inc
VIDAS Estradiol II, REF 30431-01 2 12/28/2021 bioMerieux, Inc.
Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . M... 2 12/09/2021 Philips North America 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.
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT System ... 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 - 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 - CT Vision ACQSIM CT System Number... 2 11/24/2021 Philips North America Llc
Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage... 2 11/17/2021 Fujifilm Irvine Scientific, Inc.
Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage... 2 11/17/2021 Fujifilm Irvine Scientific, Inc.
BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphili... 2 11/16/2021 Bio-Rad Laboratories, 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.
The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear ... 2 11/03/2021 Bayer Medical Care, Inc.
3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SK... 2 11/01/2021 3M Company - Health Care Business
Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and F... 2 10/21/2021 Medtronic Xomed, Inc.
Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and F... 2 10/21/2021 Medtronic Xomed, Inc.
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system 2 10/02/2021 GE Healthcare, LLC
Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic pr... 2 09/28/2021 Deerfield Imaging, Inc.
Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic pr... 2 09/28/2021 Deerfield Imaging, Inc.
Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic pr... 2 09/28/2021 Deerfield Imaging, Inc.
Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for exte... 2 09/24/2021 Elekta Inc
syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy ... 2 09/10/2021 Siemens Medical Solutions USA, Inc
Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with locali... 2 09/08/2021 Ion Beam Applications S.A.
728327 Ingenuity CT Upgrades-Computed Tomography X-ray system 2 08/18/2021 Philips North America Llc
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades 2 08/18/2021 Philips North America Llc
TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15... 2 08/12/2021 Bard Peripheral Vascular Inc
EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm 2 08/12/2021 Bard Peripheral Vascular Inc
Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthoped... 2 08/09/2021 NEOSTEO
RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B an... 2 07/23/2021 RAYSEARCH LABORATORIES AB
3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-... 3 07/21/2021 Mindray DS USA, Inc. dba Mindray North America
Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one... 2 07/16/2021 Fresenius Medical Care Holdings, Inc.
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be use... 2 07/16/2021 Fresenius Medical Care Holdings, Inc.
NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one c... 2 07/16/2021 Fresenius Medical Care Holdings, Inc.
Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI System, REF: MRT-1504 - Pr... 2 07/09/2021 Canon Medical System, USA, INC.
Nonsterile Radial/Femoral Angiography Drape, Catalog Number 29529N - Product Usage: intended to be u... 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
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use ... 2 06/30/2021 Philips North America Llc
5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyuret... 2 06/30/2021 Bard Access Systems Inc.
Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part... 2 06/15/2021 Radiometer Medical ApS
Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part. 2 06/15/2021 Radiometer Medical ApS
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, T... 2 06/14/2021 Abbott Laboratories Inc. (St Jude Medical)
WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012 2 06/14/2021 Abbott Laboratories Inc. (St Jude Medical)
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate... 2 06/14/2021 Abbott Laboratories Inc. (St Jude Medical)
ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product ... 2 06/10/2021 Brainlab AG
ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be ... 2 06/09/2021 Viewray, Inc.
The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used... 2 06/04/2021 Terumo Cardiovascular Systems Corporation
The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for... 2 06/04/2021 Terumo Cardiovascular Systems Corporation
ZVplasty 10G, 20mm, Traditional Unipedicular Kit, REF VCF-1020-1. For use in Orthopedic / spinal pr... 2 06/01/2021 Zavation
ZVPlasty, 11G, 15mm Traditional Bipedicular Kit, REF VCF-1115-2. For use in Orthopedic / spinal pro... 2 06/01/2021 Zavation
The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is mad... 2 05/26/2021 CooperSurgical, Inc.
Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization T... 2 05/20/2021 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9... 2 05/14/2021 RAYSEARCH LABORATORIES AB
NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000 2 05/10/2021 Abbott Laboratories Inc. (St Jude Medical)
ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity" and Endurity" pace... 1 05/07/2021 St. Jude Medical, Cardian Rhythm Management Division
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity" and... 1 05/07/2021 St. Jude Medical, Cardian Rhythm Management Division
Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD... 2 05/07/2021 Meridian Bioscience Inc
CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia.... 2 05/04/2021 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrh... 2 05/04/2021 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia. Addi... 2 05/04/2021 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Programmers - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P d... 2 05/04/2021 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P... 2 04/30/2021 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 S... 2 04/19/2021 Siemens Medical Solutions USA, Inc
NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-Humer... 2 04/05/2021 Nuvasive Specialized Orthopedics Inc
NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System End Cap for PRECICE In... 2 04/05/2021 Nuvasive Specialized Orthopedics Inc
Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web base... 2 04/02/2021 Fujifilm Medical Systems U.S.A., 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)
S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components th... 2 03/24/2021 Stryker Communications
Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 ... 2 03/18/2021 Epimed International, Inc.
CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radios... 2 03/17/2021 Accuray Incorporated
CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 16mm Material Number: 66-116 - Product ... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 14mm Material Number: 66-114 - Product ... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 20mm Material Number: 66-120 - Product ... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 24m Material Number: 66-124 - Product U... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 24mm Material Number: 66-224 - Product U... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 26mm Material Number: 66-226 - Product U... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 28mm Material Number: 66-228 - Product U... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 32mm Material Number: 66-232 - Product U... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 34mm Material Number: 66-234 - Product U... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 36mm Material Number: 66-236 - Product U... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 38mm Material Number: 66-238 - Product U... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 40mm Material Number: 66-240 - Product U... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 42mm Material Number: 66-242 - Product U... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 42mm Material Number: 66-342 - Product ... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 45mm Material Number: 66-345 - Product ... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 48mm Material Number: 66-348 - Product ... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 12mm Material Number: 66-112 - Product ... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - Product ... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 51mm Material Number: 66-351 - Product U... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 54mm Material Number: 66-354 - Product U... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 57mm Material Number: 66-357 - Product U... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 60mm Material Number: 66-360 - Product U... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 63mm Material Number: 66-363 - Product U... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 60mm Material Number: 66-460 - Product U... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 64mm Material Number: 66-464 - Product U... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 68mm Material Number: 66-468 - Product U... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 72mm Material Number: 66-472 - Product U... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 76mm Material Number: 66-476 - Product U... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 80mm Material Number: 66-480 - Product U... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 84mm Material Number: 66-484 - Product U... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 88mm Material Number: 66-488 - Product U... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 100mm Material Number: 66-5100 - Produc... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 105mm Material Number: 66-5105 - Produc... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 75mm Material Number: 66-575 - Product ... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 80mm Material Number: 66-580 - Product ... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 85mm Material Number: 66-585 - Product ... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 90mm Material Number: 66-590 - Product ... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 95mm Material Number: 66-595 - Product ... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 22mm Material Number: 66-122 - Product ... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 30mm Material Number: 66-230 - Product U... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 18mm Material Number: 66-118 - Product ... 2 03/11/2021 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System). 2 03/08/2021 Brainlab AG
Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY 2 03/04/2021 Barco N.V.
Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Produ... 2 03/02/2021 Shanghai United Imaging Healthcare Co., Ltd.
LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syn... 2 02/17/2021 LumiraDx
GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage... 2 02/09/2021 GE Healthcare, LLC
Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection dur... 2 02/05/2021 Cook Inc.
PBD-203-0710 BILIARY STENT, model no. PBD-203-0710 -Product Usage: Used with endoscopes for endoscop... 2 02/05/2021 Aomori Olympus Co., Ltd.
PBD-203-0707 BILIARY STENT, model no. PBD-203-0707 -Product Usage: Used with endoscopes for endoscop... 2 02/05/2021 Aomori Olympus Co., Ltd.
PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with endoscopes for endosco... 2 02/05/2021 Aomori Olympus Co., Ltd.
PBD-203-0704 BILIARY STENT, model no. PBD-203-0704 -Product Usage: Used with endoscopes for endoscop... 2 02/05/2021 Aomori Olympus Co., Ltd.
Emission Computed Tomography System Image Process System - Product Usage: intended for general Nucle... 2 01/13/2021 Philips North America, LLC
GE NM/CT 860 system Model Number H3908AD - 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
GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imag... 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
GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine ... 2 01/13/2021 GE Healthcare, LLC
Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model ... 2 01/13/2021 GE Healthcare, LLC
TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for th... 2 01/07/2021 Accuray Incorporated
TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and prec... 2 01/07/2021 Accuray Incorporated
3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003; 5mL Syringe w/Spinning Spiros, Red Cap, REF: CH... 2 12/23/2020 ICU Medical, Inc.
Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30") Appx 3.2 ml, 20 Drop ... 2 12/23/2020 ICU Medical, Inc.
30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger, REF:... 2 12/23/2020 ICU Medical, Inc.
5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 cm) Appx 9.1 ml, 20 Dro... 2 12/23/2020 ICU Medical, Inc.
MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardi... 2 12/10/2020 Shimadzu Medical Systems
Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product U... 2 12/10/2020 Shimadzu Medical Systems
Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Mad... 2 12/04/2020 Shimadzu Medical Systems
CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography Syst... 2 12/03/2020 Canon Medical System, USA, INC.
MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver pr... 2 11/24/2020 Mevion Medical Systems, Inc.
Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Nu... 2 11/23/2020 Bayer Medical Care, Inc.
ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequenc... 2 11/20/2020 Viewray, Inc.
ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Rang... 2 11/20/2020 Viewray, Inc.
RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.... 2 11/20/2020 RAYSEARCH LABORATORIES AB
XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, ... 3 11/06/2020 XTANT Medical
Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; M00545900; M00545910; M... 2 10/23/2020 Boston Scientific Corporation
Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G1503... 2 10/14/2020 Cook Inc.
Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508. T... 2 10/14/2020 Cook Inc.
Change Healthcare Radiology Solutions 14.0 2 10/08/2020 CHANGE HEALTHCARE CANADA COMPANY
Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NAMIC Cath Lab and Interv... 2 10/07/2020 Medline Industries Inc
Kit Model #650305414, MTO Left Heart with DT Boulder Com Hosp - Product Usage: NAMIC Cath Lab and In... 2 10/07/2020 Medline Industries Inc
Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Usage: NAMIC Cath Lab and... 2 10/07/2020 Medline Industries Inc
Kit Model #65193091, MTO Left Heart Kit - Product Usage: NAMIC Cath Lab and Interventional Radiology... 2 10/07/2020 Medline Industries Inc
Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage: NAMIC Cath Lab and Int... 2 10/07/2020 Medline Industries Inc
Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage: NAMIC Cath Lab and Int... 2 10/07/2020 Medline Industries Inc
Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAMIC Cath Lab and Interve... 2 10/07/2020 Medline Industries Inc
Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NAMIC Cath Lab and Interv... 2 10/07/2020 Medline Industries Inc
NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree B... 2 10/07/2020 Nuvasive Specialized Orthopedics Inc
PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, meth... 2 10/02/2020 Ultradent Products, Inc.
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.
Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and admin... 2 08/28/2020 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.
Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC, RC7221-25BC, RC7504-17... 2 08/24/2020 Klarity Medical Products LLC
DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intende... 2 08/17/2020 Synthes (USA) Products LLC
NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use in the replacement of ... 2 08/13/2020 Arrow International Inc
Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The Barricaid® ACD is indicated fo... 2 08/13/2020 Intrinsic Therapeutics, Inc.
PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and ... 2 08/10/2020 Smith & Nephew, Inc.
Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is... 2 08/07/2020 Ion Beam Applications S.A.
Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product Usage: CHEST DRAINAGE: ... 2 08/03/2020 TELEFLEX MEDICAL INC
Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - Product Usage: CHEST DRAINAGE: To eva... 2 08/03/2020 TELEFLEX MEDICAL INC
TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses 2 07/27/2020 Chengdu Ai Qin E-commerce Co., Ltd
TTDEYE (brand) Radial Pink, B16112110 - Product Usage: Colored contact lenses 2 07/27/2020 Chengdu Ai Qin E-commerce Co., Ltd
Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is ... 2 07/27/2020 Ion Beam Applications S.A.
Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Number: AC0019 GTIN / UPN: 2... 2 07/23/2020 Medtronic Sofamor Danek USA Inc
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Number: AC0016 GTIN / UPN: 2... 2 07/23/2020 Medtronic Sofamor Danek USA Inc
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Number: AC0009 GTIN / UPN: ... 2 07/23/2020 Medtronic Sofamor Danek USA Inc
Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Number: AC0007 GTIN / UPN: ... 2 07/23/2020 Medtronic Sofamor Danek USA Inc
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Number: AC0005 GTIN /UPN: 2... 2 07/23/2020 Medtronic Sofamor Danek USA Inc
Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Number: AC0012 GTIN / UPN: ... 2 07/23/2020 Medtronic Sofamor Danek USA Inc
MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to pat... 2 07/22/2020 Mevion Medical Systems, Inc.
Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision... 2 07/21/2020 Medtronic Xomed, Inc.
Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - ... 2 07/14/2020 Shimadzu Medical Systems
TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) a... 2 07/10/2020 Abbott
uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ trai... 2 07/08/2020 Shanghai United Imaging Healthcare Co., Ltd.
Elekta Unity, Image-Guided Radiation Therapy System 2 06/30/2020 Elekta, Inc.
MEVION S250i, MEVION S250; Proton Radiation Treatment System 2 06/22/2020 Mevion Medical Systems, Inc.
BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system wit... 2 06/11/2020 Becton, Dickinson and Company, BD Biosciences
RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation therapy and medical onc... 2 06/10/2020 RAYSEARCH LABORATORIES AB
RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical... 2 06/10/2020 RAYSEARCH LABORATORIES AB
RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and medical oncology which... 2 06/10/2020 RAYSEARCH LABORATORIES AB
RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medica... 2 06/10/2020 RAYSEARCH LABORATORIES AB
RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical... 2 06/10/2020 RAYSEARCH LABORATORIES AB
RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology whic... 2 06/10/2020 RAYSEARCH LABORATORIES AB
RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medic... 2 06/10/2020 RAYSEARCH LABORATORIES AB
RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology whi... 2 06/10/2020 RAYSEARCH LABORATORIES AB
RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radiation therapy and medic... 2 06/10/2020 RAYSEARCH LABORATORIES AB
RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medic... 2 06/10/2020 RAYSEARCH LABORATORIES AB
RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology whi... 2 06/10/2020 RAYSEARCH LABORATORIES AB
RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical oncology whi... 2 06/10/2020 RAYSEARCH LABORATORIES AB
RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medic... 2 06/10/2020 RAYSEARCH LABORATORIES AB
RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Product Usage: For radiation... 2 06/10/2020 RAYSEARCH LABORATORIES AB
RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy and medical oncology whic... 2 06/10/2020 RAYSEARCH LABORATORIES AB
Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digi... 2 06/09/2020 Canon Medical System, USA, INC.
Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digi... 2 06/09/2020 Canon Medical System, USA, INC.
Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digi... 2 06/09/2020 Canon Medical System, USA, INC.
RadiForce RX360, model 0FTD2346 - Product Usage: is a color LCD monitor indicated for use in display... 2 06/08/2020 Eizo Corporation
RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Product Usage: is indicated f... 2 06/08/2020 Eizo Corporation
Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicate... 2 06/05/2020 Elekta, Inc.
Genicon Natura Model 210-105-251, 5mm diameter, 150mm length (1 cannula) - Product Usage: The univer... 2 06/05/2020 Genicon, Inc.
Genicon GENILook Model 200-105-252, 5mm diameter, 150mm length (2 cannula) - Product Usage: The univ... 2 06/05/2020 Genicon, Inc.
Genicon Natura Model 210-005-052, 5mm diameter, 70mm length (two cannula, threaded) - Product Usage:... 2 06/05/2020 Genicon, Inc.
Genicon Natura Model 210-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usage... 2 06/05/2020 Genicon, Inc.
Genicon GENILook Model 200-005-151, 5mm diameter, 100mm length (one cannula, threaded) - Product Usa... 2 06/05/2020 Genicon, Inc.
Genicon GENILook Model 200-005-152, 5mm diameter, 100mm legnth (2 cannula, threaded) - Product Usage... 2 06/05/2020 Genicon, Inc.
Genicon GENILook Model 200-005-153; 5mm diameter, 100mm length (three cannula) - Product Usage: The ... 2 06/05/2020 Genicon, Inc.
Genicon GENILook Model 200-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usa... 2 06/05/2020 Genicon, Inc.
Genicon GENILook Model 200-105-151, 5mm diameter, 100mm length (one cannula) - Product Usage: The un... 2 06/05/2020 Genicon, Inc.
Genicon GENILook Model 200-105-152, 5mm diameter, 100mm length (2 cannula) - Product Usage: The univ... 2 06/05/2020 Genicon, Inc.
Genicon GENILook Model 200-105-251, 5mm diameter, 150mm length (1 cannula) - Product Usage: The univ... 2 06/05/2020 Genicon, Inc.
Genicon Natura Model 210-005-051; 5mm diameter, 70mm length (one cannula, threaded) - Product Usage:... 2 06/05/2020 Genicon, Inc.
Genicon Natura Model 210-005-151; 5mm diameter, 100mm length (one cannula, threaded) - Product Usage... 2 06/05/2020 Genicon, Inc.
Genicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, threaded) - Product Usage... 2 06/05/2020 Genicon, Inc.
4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, ... 2 06/05/2020 Biocare Medical, LLC
AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product U... 2 06/03/2020 Agfa N.V.
Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079... 2 05/22/2020 Argon Medical Devices, Inc
Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808. 2 05/22/2020 GE Healthcare, LLC
Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09... 2 05/14/2020 Ra Medical Systems, Inc.
Philips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guida... 2 05/08/2020 Philips North America, LLC
Philips Zenition 70, System code 718133 - Product Usage: The devices are used for radiological guida... 2 05/08/2020 Philips North America, LLC
Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611 Ball... 2 05/08/2020 Cook Inc.
System AXIOM Aristos FX Plus - A dedicated x-ray system with a flat panel detector which allows the ... 2 05/05/2020 Siemens Medical Solutions USA, Inc
System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat panel detector which a... 2 05/05/2020 Siemens Medical Solutions USA, Inc
Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definitio... 2 05/05/2020 Varian Medical Systems, Inc.
Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco sy... 2 04/29/2020 Elekta Inc
Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: gene... 2 04/28/2020 Philips North America, LLC
ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatmen... 2 04/27/2020 Viewray, Inc.
PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT 2 04/24/2020 Merit Medical Systems, Inc.
R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124; REF/UDI: 257-2010D(01)... 2 04/16/2020 Epimed International
R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI: 257-1810D(01)... 2 04/16/2020 Epimed International
Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System ... 2 04/10/2020 Abbott
aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00 2 04/06/2020 AAP Implantate Ag
BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, ... 2 04/02/2020 Bard Peripheral Vascular 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.
MiniMed Paradigm 511 pump 2 03/26/2020 Medtronic Inc.
MiniMed Paradigm 512 pump 2 03/26/2020 Medtronic Inc.
Medtronic MiniMed Paradigm Veo pump , model numbers MMT-554CM and MMT-754CM 2 03/26/2020 Medtronic Inc.
Medtronic MiniMed Paradigm Veo Insulin pump , model numbers MMT-554 and MMT-754 2 03/26/2020 Medtronic Inc.
Medtronic MiniMed Paradigm pump , model number MMT-723 2 03/26/2020 Medtronic Inc.
MiniMed Paradigm pump , model number MMT-712 2 03/26/2020 Medtronic Inc.
Medtronic MiniMed Paradigm pump , model number MMT-712E 2 03/26/2020 Medtronic Inc.
Medtronic MiniMed Paradigm pump , model numbers MMT 515 and MMT-715 2 03/26/2020 Medtronic Inc.
Medtronic MiniMed Paradigm pump , model number MMT-522 2 03/26/2020 Medtronic Inc.
Medtronic MiniMed Paradigm pump , model number MMT-722 2 03/26/2020 Medtronic Inc.
Medtronic MiniMed Paradigm pump , model number MMT-522K 2 03/26/2020 Medtronic Inc.
Medtronic MiniMed Paradigm pump , model number MMT-722K 2 03/26/2020 Medtronic Inc.
Medtronic MiniMed Paradigm pump , model number MMT-523 2 03/26/2020 Medtronic Inc.
Medtronic MiniMed Paradigm pump , model number MMT-523K 2 03/26/2020 Medtronic Inc.
Medtronic MiniMed Paradigm pump , model number MMT-723K 2 03/26/2020 Medtronic Inc.
RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0... 2 03/26/2020 RAYSEARCH LABORATORIES AB
NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety (Patient S... 2 03/22/2020 Hill-Rom Inc.
AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Produ... 2 03/18/2020 Agfa N.V.
Stryker Connected OR Cart,120 V Ref Cat. #240-099-155, Qty 1, Rx Only, Manufactured for: Stryker, 59... 2 03/05/2020 Stryker Corporation
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.
Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protect... 2 02/24/2020 Breas Medical, Inc.
ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM A... 2 02/20/2020 Siemens Medical Solutions USA, Inc
Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospital... 2 02/20/2020 Siemens Medical Solutions USA, Inc
VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and... 2 02/10/2020 Philips North America, LLC
Centurion- Pathology Container 1150ST STERILE GRADUATED CONTAINER, 32 OZ. 17070 AI OR CARDIAC STER... 2 02/05/2020 Centurion Medical Products Corporation
Centurion-Suture Trays SUT10140 SUTURE TRAY SUT10290 LACERATION TRAY SUT10705 SUTURING TRAY SUT1... 2 02/05/2020 Centurion Medical Products Corporation
Centurion-Surgical Tray MNS10255 DELIVERY TRAY MNS10255 DELIVERY TRAY MNS10310 MEATOTOMY TRAY MN... 2 02/05/2020 Centurion Medical Products Corporation
Centurion- Dressing Change Kits DYNDC1182B PICC INSERTION TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC... 2 02/05/2020 Centurion Medical Products Corporation
Centurion-_General Surgery Trays DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 DYNDA1178 ICIO TRAY DYNDA1... 2 02/05/2020 Centurion Medical Products Corporation
Centurion-Pitcher Kit GR100150ST GRADUATED PITCHER STERILE 1000 CC Y 2018121090 GR1200ST STERILE 1... 2 02/05/2020 Centurion Medical Products Corporation
Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. U... 2 02/05/2020 Zimmer Biomet, Inc.
Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer ... 2 01/23/2020 Arrow International Inc
LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that c... 2 01/16/2020 Physio-Control, Inc.
Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-... 2 01/07/2020 Stryker GmbH
There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexit... 2 01/02/2020 Nucletron BV
Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of rout... 2 12/31/2019 Villa Sistemi Medicali S.P.A.
Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is a remote c... 2 12/31/2019 Villa Sistemi Medicali S.P.A.
Apollo DRF, Model Number 9784220831 - Product Usage: The remote controlled table Apollo DRF is an X-... 2 12/31/2019 Villa Sistemi Medicali S.P.A.
Apollo EZ, Model Number 9784152036 - Product Usage: The Apollo EZ remote-controlled table is X-ray e... 2 12/31/2019 Villa Sistemi Medicali S.P.A.
iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite ... 2 12/31/2019 Deerfield Imaging, Inc.
RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.... 2 12/23/2019 RAYSEARCH LABORATORIES AB
CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usa... 2 12/20/2019 Abbott Medical
Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent System devices are designe... 2 12/20/2019 Cardinal Health Inc.
ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated - Product Usage: The electroencephalo... 2 12/20/2019 LIFELINES NEURO COMPANY
Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 007... 2 12/19/2019 Medtronic Navigation, Inc.
MICRO-PSD HDR, Catalog Number: PSD-HB5N - Product Usage: pre-calibrated PSD sensors are intended for... 2 12/19/2019 Angiodynamics, Inc.
MICRO-PSD Electron, Catalog Number: PSD-EE5N - Product Usage: pre-calibrated PSD sensors are intende... 2 12/19/2019 Angiodynamics, Inc.
OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Number: ORB-60F - Product Us... 2 12/19/2019 Angiodynamics, Inc.
OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - Product Usage: pre-calibrated PSD... 2 12/19/2019 Angiodynamics, Inc.
MICRO-PSD EXTERNAL BEAM PHOTON, Catalog Number: PSD-PE5N - Product Usage: pre-calibrated PSD sensors... 2 12/19/2019 Angiodynamics, Inc.
Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-elect... 2 12/12/2019 Neuronetrix Solutions, LLC dba Cognision
MRIdian Linac Radiation Therapy System Model 10000 and 20000 2 12/12/2019 Viewray, Inc.
Monaco Radiation Treatment Planning System (RTP) System 2 12/12/2019 Elekta Inc
BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagno... 2 12/12/2019 Leica Microsystems, Inc.
Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Usage: The Habib EUS R... 2 12/11/2019 Boston Scientific Corporation
Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS R... 2 12/11/2019 Boston Scientific Corporation
Radiofrequency Grounding Pad, REF RF-DGP-L 2 12/10/2019 Abbott Medical
The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric, non-complia... 2 11/21/2019 Nucryo Vascular Inc.
ORTHOFIX Catalogue Number: ref: 99-36501, RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM- STERILE, ... 2 11/14/2019 Orthofix Srl
PERI DIST VOLAR/DORSAL T/DORSAL DELTA RADIAL, Item Nos. 00234801303 00234801304 00234801306 002... 2 11/07/2019 Zimmer Biomet, Inc.
Coorad Morrey Total Elbow, Item Nos. 32810502501 32810502701 32810502900 32810503000 32810600012... 2 11/07/2019 Zimmer Biomet, Inc.
SM DIS VOL/DORS RAD LAT COL PLATE, Item Nos. 47235801404 47235802102 47235802103 47235802104 472... 2 11/07/2019 Zimmer Biomet, Inc.
(1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 cl... 2 11/05/2019 Argon Medical Devices, Inc
Minimed Model 503 Remote Transmitter (MMT-503, MMT-503EU, MMT-503NA, MMT-503US) for use with the Min... 1 11/04/2019 Medtronic 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
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of sin... 1 11/01/2019 Philips Medical Systems (Cleveland) Inc
OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly... 3 10/18/2019 Xintec Corp
Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Pr... 3 10/02/2019 CooperSurgical, Inc.
SHERPA NX ACTIVE GUIDING CATHETER, 6F RRAD, .070", REF SA6RRAD. for cardiovascular use 1 10/01/2019 Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F M RADIAL, .070", REF SA6MRADIAL. for cardiovascular use 1 10/01/2019 Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT, LONG TIP, .070", REF SA6ERADLLT. for cardiovascul... 1 10/01/2019 Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT, .070", REF SA6ERADL. for cardiovascular use 1 10/01/2019 Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD RIGHT SHORT TIP, .070", REF SA6ERADRST. for cardiovascu... 1 10/01/2019 Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT SH, .070", REF SA6ERADLSH. for cardiovascular use ... 1 10/01/2019 Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD RIGHT, .070", REF SA6ERADR. for cardiovascular use 1 10/01/2019 Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT, SHORT TIP, .070", REF SA6ERADLST. for cardiovascu... 1 10/01/2019 Medtronic Vascular
Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco sys... 2 09/25/2019 Elekta Inc
Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco syst... 2 09/25/2019 Elekta Inc
The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft ... 2 09/24/2019 GETINGE US SALES LLC
Monaco Radiation Treatment Planning System (RTP) System 2 08/28/2019 Elekta, Inc.
Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with patient tables as follow... 2 08/24/2019 Siemens Medical Solutions USA, Inc
SOMATOM Definition AS, Model Number 8098027 - Product Usage: Computed tomography systems intended to... 2 08/14/2019 Siemens Medical Solutions USA, Inc
SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed tomography systems intended... 2 08/14/2019 Siemens Medical Solutions USA, Inc
SOMATOM Drive, Model Number 10431700 - Product Usage: Computed tomography systems intended to genera... 2 08/14/2019 Siemens Medical Solutions USA, Inc
SOMATOM Confidence, Model Number 10590100 - Product Usage: Computed tomography systems intended to g... 2 08/14/2019 Siemens Medical Solutions USA, Inc
SOMATOM Edge Plus, Model Number 10267000 - Product Usage: Computed tomography systems intended to ge... 2 08/14/2019 Siemens Medical Solutions USA, Inc
SOMATOM Force, Model Number 10742326 - Product Usage: Computed tomography systems intended to genera... 2 08/14/2019 Siemens Medical Solutions USA, Inc
SOMATOM Definition Flash, Model Number 10430603 - Product Usage: Computed tomography systems intende... 2 08/14/2019 Siemens Medical Solutions USA, Inc
Lantis 8.3 Commander, Model # 8148178 - Product Usage: Lantis Treatstation is to allow the radiation... 2 08/06/2019 Siemens Medical Solutions USA, Inc
Lantis Commander, Model # 4503178 - Product Usage: Lantis Treatstation is to allow the radiation t... 2 08/06/2019 Siemens Medical Solutions USA, Inc
Lantis system (pre-2003), Model #5835991 - Product Usage: Lantis Treatstation is to allow the radiat... 2 08/06/2019 Siemens Medical Solutions USA, Inc
Lantis 6.1 Commander, Model # 5493072 - Product Usage: Lantis Treatstation is to allow the radiation... 2 08/06/2019 Siemens Medical Solutions USA, Inc
STERILE FLUORO SSP TRAY Kit Code: MNS11605 - Product Usage: This kit is used for arthrogram injectio... 2 08/06/2019 Centurion Medical Products Corporation
Half Apron, Product Number Half Apron, Part Numbers REHALF*, REHALF3 Product Usage: Products are... 2 07/30/2019 Burlington Medical, LLC
Cap, Product Number Cap, Part Numbers CAP1, CAP2 Product Usage: Products are designed to protect... 2 07/30/2019 Burlington Medical, LLC
Hood, Product Number Hood, Part Numbers HOOD1, HOOD2 Product Usage: Products are designed to pro... 2 07/30/2019 Burlington Medical, LLC
Porta Shield, Product Number Porta Shield, Part Numbers PTS2, PTS3, PTS4 Product Usage: Products... 2 07/30/2019 Burlington Medical, LLC
Thyroid Collar Oversize, Product Number TS3, Part Numbers RBTS3-R, RETS3-R, RLTS3-R, RLTS3-SEP, RLTS... 2 07/30/2019 Burlington Medical, LLC
GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images th... 2 07/30/2019 GE Healthcare, LLC
Frontal Stretch Buckle Closure Apron, Product Number A-10, Part Numbers REA10A, REA10B, REA10C, REA1... 2 07/30/2019 Burlington Medical, LLC
Frontal Apron Velcro Closure, Product Number F-17, Part Numbers REF17A, REF17B, REF17C, REF17D, REF1... 2 07/30/2019 Burlington Medical, LLC
Frontal Support Belt Apron, Product Number F-15, Part Numbers REF15*F, REF15*M, REF15B, REF15XLM ... 2 07/30/2019 Burlington Medical, LLC
Frontal Quick Drop OR Apron, Product Number 601, Part Numbers ECRE601A, ECRE601B, ECRE601C, ECRE601X... 2 07/30/2019 Burlington Medical, LLC
1 pc Full Wrap Support Belt Apron, Product Number F111, Part Numbers MTREF111*F, MTREF111E, MTREF111... 2 07/30/2019 Burlington Medical, LLC
2 pc Full Wrap Vest & Kilt, Product Number VK, Part Numbers ECREVKA, ECREVKB, ECREVKC, ECREVKXLM, EC... 2 07/30/2019 Burlington Medical, LLC
Vest, Single Item, Product Number Vest, Part Numbers ECREVESTD, ECREVESTF, ECREVESTXLF, REVEST*M, RE... 2 07/30/2019 Burlington Medical, LLC
2 pc Full Overlap Vest & Kilt, Single Item, Product Number FVK, Part Numbers REFVK*F, REFVK*M, REFVK... 2 07/30/2019 Burlington Medical, LLC
2 pc Full Wrap Vest & Kilt Back-Saver , Product Number PVK, Part Numbers REPVK*F, REPVK*M, REPVKE, ... 2 07/30/2019 Burlington Medical, LLC
Peak Vest, Single Item, Product Number PVest, Part Numbers REPVEST*M, SEPVESTE, SEPVEST*F Produc... 2 07/30/2019 Burlington Medical, LLC
Kilt, Single Item, Product Number Kilt, Part Numbers ECREKILTF, ECREKILTXLF, REKILTA, REKILTB, REKIL... 2 07/30/2019 Burlington Medical, LLC
Thyroid Collar, Magnetic Closure, Product Number TS5, Part Numbers RBTS5-R, RBTS5-T2T, RLTS5-R, RLTS... 2 07/30/2019 Burlington Medical, LLC
1 pc Full Wrap Back Relief Apron, Product Number B52 Front & Back Apron, Part Numbers SEB52*F, UEB52... 2 07/30/2019 Burlington Medical, LLC
Thyroid Collar, Velcro Closure, Product Number TS2, Part Numbers RBTS2-R, RETS2-R, RLTS2PED, RLTS2-R... 2 07/30/2019 Burlington Medical, LLC
Thyroid Collar, Buckle Closure, Product Number TS4, Part Numbers RBTS4-R, RBTS4-T2T, RETS4-R, RLTS4-... 2 07/30/2019 Burlington Medical, LLC
Sleeve, Product Number Sleeve, Part Numbers RESL, SL 3 L, SL 3 M, SL 3 S, L 3 X, SL 3 XS, UESL Pr... 2 07/30/2019 Burlington Medical, LLC
Frontal Apron with Quick Drop Velcro Closure (no elastic), Product Number 401, Part Numbers RE401*M ... 2 07/30/2019 Burlington Medical, LLC
Front/Back Apron with Stretch Velcro Closure, Product Number EURO, Part Numbers ECSEEUROA, ECSEEUROB... 2 07/30/2019 Burlington Medical, LLC
AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 8... 2 07/30/2019 Agfa N.V.
Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System 2 07/27/2019 Elekta Inc
IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The i... 2 07/25/2019 Medical Intelligence Medizintechnik Gmbh
GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod ... 2 07/25/2019 Xcision Medical Systems, LLC
Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging... 2 07/16/2019 Elekta, Inc.
Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the ... 2 07/12/2019 Zimmer Biomet, Inc.
Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDr... 2 07/12/2019 Zimmer Biomet, Inc.
Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner... 1 07/11/2019 GE Healthcare, LLC
Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner t... 1 07/11/2019 GE Healthcare, LLC
Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product... 2 07/11/2019 Canon Medical System, USA, INC.
Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Comp... 2 07/03/2019 Philips Medical Systems (Cleveland) Inc
ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single) 2 07/03/2019 Bio-Detek, Inc.
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan ... 2 07/03/2019 RAYSEARCH LABORATORIES AB

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