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U.S. Department of Health and Human Services

Medical Device Recalls
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CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeo... 2 06/11/2024 Blue Belt Technologies, Inc
STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing o... 2 05/28/2024 Synthes (USA) Products LLC
2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F4... 2 05/17/2024 Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F4... 2 05/17/2024 Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F4... 2 05/17/2024 Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F4... 2 05/17/2024 Fresenius Medical Care Holdings, Inc.
INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup 2 05/01/2024 Innomed, Inc.
Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannul... 2 04/22/2024 Alcon Research, LLC
Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD i... 2 03/29/2024 Life Technologies Corporation
IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile. 2 03/28/2024 Medical Action Industries, Inc. 306
Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplificatio... 2 03/22/2024 Hologic, Inc.
HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend ... 1 03/22/2024 Thoratec Corp.
microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 ... 2 03/21/2024 Landauer
natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, R... 2 03/19/2024 Natus Neurology Inc
USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: R... 2 02/29/2024 United Orthopedic Corporation
USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: ... 2 02/29/2024 United Orthopedic Corporation
USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153... 2 02/29/2024 United Orthopedic Corporation
Centurion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT, REF IVS1860B; b) NEO... 1 02/25/2024 MEDLINE INDUSTRIES, LP - Northfield
Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL011CTASD; b) CATARA... 1 02/25/2024 MEDLINE INDUSTRIES, LP - Northfield
Medline Kits, trays, and packs labeled as follows: a) PORT ACCESS TRAY, REF DYNDA2863; b) PORT ... 1 02/25/2024 MEDLINE INDUSTRIES, LP - Northfield
IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549;... 2 02/16/2024 Voco GmbH
BD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro susceptibility testing. C... 2 02/08/2024 Becton Dickinson & Co.
The Prestige Coil System is a product family of embolic coils with associated delivery system compon... 2 02/08/2024 BALT USA, LLC
EZDilate Wire Guided Balloon 18-19-20. Indicated for endoscopic dilation of strictures in the alim... 2 01/31/2024 Olympus Corporation of the Americas
EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimenta... 2 01/31/2024 Olympus Corporation of the Americas
EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alime... 2 01/31/2024 Olympus Corporation of the Americas
EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures in the... 2 01/31/2024 Olympus Corporation of the Americas
EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in the alime... 2 01/31/2024 Olympus Corporation of the Americas
EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the a... 2 01/31/2024 Olympus Corporation of the Americas
GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fl... 2 01/30/2024 GE HEALTHCARE AUSTRIA GMBH & CO
Xstar Kojo Safety Slit Knife, 2.5mm 45® Bevel Up, Part Number 373025 2 01/04/2024 Beaver Visitec International, Inc.
Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000 2 12/22/2023 Landauer
Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG ... 2 11/07/2023 Alcon Research, LLC
Procedure packs: (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extract... 2 10/10/2023 Cardinal Health 200, LLC
Procedure packs: (1) Presource Portacath Pack, Cat. SANV1PIFSB, Medstar Franklin Square Med CE, S... 2 10/10/2023 Cardinal Health 200, LLC
2008T HD SYS. W/O CDX W/BIBAG BLUESTAR 1 10/06/2023 Fresenius Medical Care Holdings, Inc.
2008T HD SYS. CDX W/BIBAG BLUESTAR 1 10/06/2023 Fresenius Medical Care Holdings, Inc.
2008T HD SYS. CDX BLUESTAR 1 10/06/2023 Fresenius Medical Care Holdings, Inc.
2008T HD SYS. W/O CDX BLUESTAR 1 10/06/2023 Fresenius Medical Care Holdings, Inc.
(1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Fr... 2 09/29/2023 Siemens Medical Solutions USA, Inc
QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18131-000; b) 18131-KIT; c) 18131-SET; radiation... 2 09/12/2023 Landauer
QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 18135-000; b) 18135-KIT; c) 18135-SET; radiation... 2 09/12/2023 Landauer
Calibrate (unexposed) nanoDot D2DNS, Model Numbers: a) 18140-000; b) 18140-KIT; c) 18140-SET;... 2 09/12/2023 Landauer
Constancy (80 kVp) nanoDot D2DNN, Model Numbers: a) 18150-000 (EMEA number VKITCON002); b) 1815... 2 09/12/2023 Landauer
Constancy (Cs-137) nanoDot D2DNN, Model Numbers: a) 18155-000 (EMEA number VKITCON001); b) 1815... 2 09/12/2023 Landauer
NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Dots; b) BC30083, descr... 2 09/12/2023 Landauer
NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR readers 2 09/12/2023 Landauer
Reader, nanoDot adapter, EU Model Number VINLADA003; radiation monitoring dosimeter used with the mi... 2 09/12/2023 Landauer
nanoDot D2DNS, for custom calibrate, OTO, Model Number 03033-OTO; radiation monitoring dosimeter use... 2 09/12/2023 Landauer
nanoDot D2DNS, for custom calibrate, OTO, Model Numbers 03034-OTO; radiation monitoring dosimeter us... 2 09/12/2023 Landauer
nanoDot D2DNN, Model Numbers: a) 03051-1MO; b) 03051-3MO; c) 03051-OTO; d) 03051-SMO; radia... 2 09/12/2023 Landauer
nanoDot D2DNN, Model Numbers: a) 03053-1MO; b) 03053-1WK ; c) 03053-3MO; d) 03053-OTO; e)... 2 09/12/2023 Landauer
nanoDot D2DNS, Model Numbers: a) 03055-1MO; b) 03055-3MO; c) 03055-OTO; d) 03055-SMO; rad... 2 09/12/2023 Landauer
nanoDot D2DNS, Model Numbers: a) 03056-000 (EMEA number VINLNAN002); b) 03056-1MO; c) 03056-3... 2 09/12/2023 Landauer
nanoDot D2DNS, Model Numbers: a) 03057-1MO; b) 03057-3MO; c) 03057-OTO; d) 03057-SMO; rad... 2 09/12/2023 Landauer
nanoDot D2DXN, Model Numbers: a) 03060-1MO; b) 03060-3MO; c) 03060-OTO; d) 03060-SMO; radia... 2 09/12/2023 Landauer
nanoDot D2DXN, Model Numbers: a) 03061-1MO; b) 03061-3MO; c) 03061-OTO; d) 03061-SMO; radia... 2 09/12/2023 Landauer
nanoDot D2DXS, Model Numbers: a) 03062-1MO; b) 03062-3MO; c) 03062-OTO; d) 03062-SMO; radia... 2 09/12/2023 Landauer
nanoDot D2DXS, Model Numbers: a) 03063-1MO; b) 03063-3MO; c) 03063-OTO; d) 03063-SMO; radia... 2 09/12/2023 Landauer
Calibrate (80 kVp) screened nanoDot D2DNS, Model Number 03064-OTO; radiation monitoring dosimeter us... 2 09/12/2023 Landauer
Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 03065-OTO; radiation monitoring dosimeter us... 2 09/12/2023 Landauer
QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitoring dosimeter used with... 2 09/12/2023 Landauer
QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitoring dosimeter used with... 2 09/12/2023 Landauer
nanoDot kit (contains nanoDot A, B, C), Model Number 03500-000; radiation monitoring dosimeter used ... 2 09/12/2023 Landauer
nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used w... 2 09/12/2023 Landauer
nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; radiation monitoring dosimeter used w... 2 09/12/2023 Landauer
nanoDot C - item 3 of 3 for 03500-000, Model Number 03503-000; radiation monitoring dosimeter used w... 2 09/12/2023 Landauer
Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 04217-000 (EMEA number VINLNAN003); b) 0421... 2 09/12/2023 Landauer
QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 04218-000 (EMEA number VINLNAN004); b) 04218-KIT; ... 2 09/12/2023 Landauer
Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 04224-000 (EMEA number VINLNAN006); b) 0422... 2 09/12/2023 Landauer
QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 04225-000 (EMEA number VINLNAN005); b) 04225-KIT; ... 2 09/12/2023 Landauer
nanoDot D2DNN , Model Numbers: a) 04293-000; b) 04293-KIT; radiation monitoring dosimeter used ... 2 09/12/2023 Landauer
nanoDot D2DNS, Model Numbers: a) 18100-000; b) 18100-1MO; c) 18100-2MO; d) 18100-KIT; radia... 2 09/12/2023 Landauer
nanoDot D2DNN, Model Numbers: a) 18105-000; b) 18105-KIT; radiation monitoring dosimeter used w... 2 09/12/2023 Landauer
Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18120-000; b) 18120-KIT; c) 18120-SET; ra... 2 09/12/2023 Landauer
Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18121-000; b)18121-KIT; c) 18121-SET; rad... 2 09/12/2023 Landauer
Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 18125-000; b) 18125-KIT; c) 18125-SET; ra... 2 09/12/2023 Landauer
QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18130-000; b) 18130-KIT; c) 18130-SET; radiation... 2 09/12/2023 Landauer
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
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL L... 2 07/20/2023 MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) RADIAL ART... 2 07/20/2023 MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) IV SECUR... 2 07/20/2023 MEDLINE INDUSTRIES, LP - Northfield
RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control m... 3 06/07/2023 Mechatronics USA
RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality c... 3 06/07/2023 Mechatronics USA
VentStar Anesthesia WT (P)180, MP00374 1 05/17/2023 Draeger Medical, Inc.
Ventstar Coax 230, MP03376 1 05/17/2023 Draeger Medical, Inc.
Ventstar Coax 180, MP03374 1 05/17/2023 Draeger Medical, Inc.
Ventstar Coax, MP03373 1 05/17/2023 Draeger Medical, Inc.
VentStar Coax (P) 150, MP00379 1 05/17/2023 Draeger Medical, Inc.
VentStar Bag Set (N) 110, MP00383 1 05/17/2023 Draeger Medical, Inc.
VentStar Watertrap (N) 180, MP00363 1 05/17/2023 Draeger Medical, Inc.
VentStar Basic (N) 180, MP00353 1 05/17/2023 Draeger Medical, Inc.
VentStar Anesthesia (N) 180, MP00333 1 05/17/2023 Draeger Medical, Inc.
VentStar breathing bag Set (P) 110, MP00384 1 05/17/2023 Draeger Medical, Inc.
VentStar Watertrap (P) 180 w/oLL, MP00362 1 05/17/2023 Draeger Medical, Inc.
VentStar Watertrap (P) 180, MP00361 1 05/17/2023 Draeger Medical, Inc.
VentStar Basic (P)180, MP00351 1 05/17/2023 Draeger Medical, Inc.
VentStar Basic (P)250, MP00352 1 05/17/2023 Draeger Medical, Inc.
Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC ... 2 03/28/2023 Alcon Research, LLC
NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and... 1 02/24/2023 Draeger Medical, Inc.
NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01... 1 02/24/2023 Draeger Medical, Inc.
Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A 2 02/22/2023 Cardinal Health 200, LLC
Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553E 2 02/22/2023 Cardinal Health 200, LLC
Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG #: 01-5798B 2 02/22/2023 Cardinal Health 200, LLC
Sterile Procedural Trays, labeled as the following: a. SPINAL b. SPINE CDS c. TOTAL ORTHO CDS d. ... 2 02/06/2023 MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR... 2 02/06/2023 MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR BASIN SET UP b. SINGLE ... 2 02/06/2023 MEDLINE INDUSTRIES, LP - Northfield
Mammotome MammoStar Biopsy Site Identified, REF STAR1401 2 01/30/2023 Carbon Medical Technologies, Inc.
Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M C... 2 01/04/2023 Windstone Medical Packaging, Inc.
Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in catara... 2 01/04/2023 Beaver Visitec International, Inc.
2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis the... 2 12/20/2022 Fresenius Medical Care Holdings, Inc.
DeRoyal CATARACT PACK, REF 89-9241.04 2 12/15/2022 DeRoyal Industries Inc
DeRoyal CATARACT PACK, REF 89-9241.03 2 12/15/2022 DeRoyal Industries Inc
DeRoyal CATARACT PACK, REF 89-8859.08 2 12/15/2022 DeRoyal Industries Inc
DeRoyal CATARACT PACK, REF 89-8650.10 2 12/15/2022 DeRoyal Industries Inc
DeRoyal CATARACT PACK, REF 89-10040.01 2 12/15/2022 DeRoyal Industries Inc
GEO-MED CATARACT PACK, REF 89-5790.08 2 12/15/2022 DeRoyal Industries Inc
DeRoyal CATARACT PACK, REF 89-7135.10 2 12/15/2022 DeRoyal Industries Inc
DeRoyal CATARACT PACK CSM, REF 89-6863 2 12/15/2022 DeRoyal Industries Inc
DeRoyal CATARACT PACK, REF 89-10086.05 2 12/15/2022 DeRoyal Industries Inc
Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical A... 2 12/08/2022 Medical Action Industries, Inc. 306
NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgica... 2 12/03/2022 Medacta Usa Inc
regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kit 2 11/23/2022 ROi CPS LLC
regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit 2 11/23/2022 ROi CPS LLC
18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, m... 1 11/15/2022 Insulet Corporation
Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. C... 2 11/03/2022 Baxter Healthcare Corporation
BAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. Convenience kit used in surgical procedures. 2 11/01/2022 MEDLINE INDUSTRIES, LP - Northfield
BAUSCH + LOMB CATARACT TRAY, REF LYN023FACTB. Convenience kit used in surgical procedures. 2 11/01/2022 MEDLINE INDUSTRIES, LP - Northfield
BAUSCH + LOMB CATARACT PACK, REF VAL009CTSGA. Convenience kit used in surgical procedures. 2 11/01/2022 MEDLINE INDUSTRIES, LP - Northfield
Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products);... 3 09/26/2022 Baxter Healthcare Corporation
Various eye packs, cataract packs 2 09/08/2022 American Contract Systems, Inc.
a. McKesson DISINFECTANT, GLUTARALDEHYDE 28DAY (4GL/CS) MGM68, Model Number: 68-102800. b. MET... 2 08/26/2022 Mckesson Medical-Surgical Inc. Corporate Office
MedSource IV Start kit, 8inch Extension Set IV START KIT, W/SITE LOC/8" EX100/CS Model Number:... 2 08/26/2022 Mckesson Medical-Surgical Inc. Corporate Office
Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOS... 2 07/12/2022 Alcon Research, LLC
Drager SafeStar 55, Catalog No. MP01790 1 06/10/2022 Draeger Medical, Inc.
I.V. Start Kit Catalog 8172 2 05/28/2022 Busse Hospital Disposables, Inc.
I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822 2 05/28/2022 Busse Hospital Disposables, Inc.
Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO 1 05/19/2022 Abbott Vascular
The following first aid kits and cabinets containing components Medi-First XS Non-Aspirin, Product #... 2 05/11/2022 Certified Safety Mfg Inc
ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery. 2 04/26/2022 Carl Zeiss Meditec AG
Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item N... 2 04/26/2022 ROi CPS LLC
Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number:... 2 04/26/2022 ROi CPS LLC
Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item N... 2 04/26/2022 ROi CPS LLC
NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the fo... 2 04/22/2022 NeuMoDx Molecular Inc
Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site 2 04/18/2022 Resource Optimization & Innovation LLC
Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YE... 2 04/06/2022 Philips North America LLC
Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS 2 04/06/2022 Philips North America LLC
Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive C... 2 03/31/2022 Microbiologics Inc
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A S... 2 03/01/2022 Microbiologics Inc
Destino Twist 14F (also branded as Guidestar 14F) 2 02/17/2022 Oscor Inc.
Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration st... 2 01/10/2022 Philips North America Llc
Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cata... 2 12/21/2021 Beaver Visitec International, Inc.
Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in cataract, corneal, or re... 2 12/21/2021 Beaver Visitec International, Inc.
Malosa Core Phaco Pack 2- Medical Refractive Kit intended to be used to aid in cataract, corneal, or... 2 12/21/2021 Beaver Visitec International, Inc.
Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to aid in cataract, corne... 2 12/21/2021 Beaver Visitec International, Inc.
Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or... 2 12/21/2021 Beaver Visitec International, Inc.
Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or ... 2 12/21/2021 Beaver Visitec International, Inc.
REGARD Basic Cataract tray 2 11/18/2021 ROi CPS LLC
Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cataract surgery. REF#: ... 2 11/16/2021 Beaver Visitec International, Inc.
bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes Cataract Surgical Kits tha... 2 11/16/2021 Beaver Visitec International, Inc.
bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#3... 2 11/16/2021 Beaver Visitec International, Inc.
bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surgical Kits that contain ... 2 11/16/2021 Beaver Visitec International, Inc.
RAPTAR Laser Range Finders 2 10/22/2021 Potomac River Group, Corp.
United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Cat... 2 10/14/2021 Uoc Usa Inc
Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A 2 10/08/2021 Philips North America LLC
Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A 2 10/08/2021 Philips North America LLC
Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304 2 10/08/2021 Philips North America LLC
Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A 2 10/08/2021 Philips North America LLC
Zoll, REF 8700-000872-40, SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Lu... 2 10/06/2021 ZOLL Circulation, Inc.
Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New L... 2 10/06/2021 ZOLL Circulation, Inc.
Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer ... 2 10/06/2021 ZOLL Circulation, Inc.
Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New... 2 10/06/2021 ZOLL Circulation, Inc.
Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.) 2 10/06/2021 ZOLL Circulation, Inc.
Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.) 2 10/06/2021 ZOLL Circulation, Inc.
Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.) 2 10/06/2021 ZOLL Circulation, Inc.
Zoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.) 2 10/06/2021 ZOLL Circulation, Inc.
Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.) 2 10/06/2021 ZOLL Circulation, Inc.
TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag... 2 10/04/2021 Johnson & Johnson Surgical Vision Inc
NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H96564038... 2 09/24/2021 Medline Industries Inc
CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitativ... 2 09/03/2021 Versea Diagnostics LLC
Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, ... 2 09/03/2021 Philips North America LLC
Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperth... 1 07/23/2021 Eight Medical International BV
SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Nonconti... 1 07/13/2021 Philips Respironics, Inc.
Myriad-LX Light Source-for delivery of light to the surgical field to enhance visualization of tissu... 2 06/09/2021 Nico Corp.
SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help p... 2 06/09/2021 Sunstar Americas, Inc.
Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope. 2 05/11/2021 Haag-Streit USA Inc
InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a thre... 2 04/27/2021 Nextremity Solutions
InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage: Intended as a thr... 2 04/27/2021 Nextremity Solutions
SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA 2 04/09/2021 Sunstar Americas, Inc.
VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP00363 - Product... 2 03/05/2021 Draeger Medical, Inc.
VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets Order Number: MP00353 - Product Us... 2 03/05/2021 Draeger Medical, Inc.
VentStar Anesthesia (N) 180 - Drager Breathing Circuits/Anesthesia Sets Order Number: MP00333 - Prod... 2 03/05/2021 Draeger Medical, Inc.
SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 - Product U... 2 03/05/2021 Sunstar Americas, Inc.
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
Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, I... 2 12/28/2020 ROi CPS LLC
Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red) 2 12/21/2020 Nova Ortho-Med Inc
Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: Th... 2 12/11/2020 Remote Diagnostic Technologies Ltd.
Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the... 2 11/25/2020 Intuitive Surgical, Inc.
Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters ... 2 11/12/2020 Maquet Cardiovascular Us Sales, Llc
Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A,... 2 10/23/2020 Philips North America, LLC
Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles, Model Numbers M1741A, M1742... 2 10/23/2020 Philips North America, LLC
CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: indicated for over-the-cou... 3 09/23/2020 OraSure Technologies, Inc.
Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M... 2 08/13/2020 Philips North America, LLC
PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and ... 2 08/10/2020 Smith & Nephew, Inc.
TTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact lenses 2 07/27/2020 Chengdu Ai Qin E-commerce Co., Ltd
TTDEYE (brand) Diamonds Starlight, B16112203 - Product Usage: Colored contact lenses 2 07/27/2020 Chengdu Ai Qin E-commerce Co., Ltd
enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is in... 2 07/10/2020 Bausch & Lomb Surgical, Inc.
PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Usage: intended to be use... 2 07/10/2020 TeDan Surgical Innovations LLC
PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used... 2 07/10/2020 TeDan Surgical Innovations LLC
PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used... 2 07/10/2020 TeDan Surgical Innovations LLC
PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usa... 2 06/16/2020 BIOSENSE WEBSTER
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: ... 2 06/16/2020 BIOSENSE WEBSTER
Infant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child Reduced Energy Defibri... 2 06/11/2020 Physio-Control, Inc.
A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Plate-Cage 3... 2 06/11/2020 Acuity Surgical Devices, LLC
A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbo... 2 06/11/2020 Acuity Surgical Devices, LLC
FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP... 2 05/28/2020 Inpeco S.A.
Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1... 2 05/28/2020 Inpeco S.A.
Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10),... 2 05/28/2020 Inpeco S.A.
Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in th... 2 05/28/2020 Philips North America, LLC
Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product U... 2 05/28/2020 Philips North America, LLC
Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compa... 2 05/27/2020 Philips North America, LLC
Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the... 2 05/20/2020 Philips North America, LLC
HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartS... 2 05/20/2020 Philips North America, LLC
The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 00... 2 05/07/2020 ICU Medical, Inc.
Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definitio... 2 05/05/2020 Varian Medical Systems, Inc.
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intended for IPS ... 2 05/01/2020 Ivoclar Vivadent AG
Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX ... 2 04/20/2020 Fresenius Medical Care Holdings, Inc.
Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell... 2 04/14/2020 Life Technologies Corporation
Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell l... 2 04/14/2020 Life Technologies Corporation
Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lu... 2 04/14/2020 Life Technologies Corporation
Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist S... 2 03/30/2020 Trilliant Surgical, LLC
Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name:... 2 03/20/2020 Fresenius Medical Care Holdings, Inc.
D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and... 2 03/17/2020 TeDan Surgical Innovations LLC
D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and... 2 03/17/2020 TeDan Surgical Innovations LLC
DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These products are intende... 2 03/17/2020 TeDan Surgical Innovations LLC
DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intende... 2 03/17/2020 TeDan Surgical Innovations LLC
HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M... 2 03/13/2020 Philips North America, LLC
Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/D... 2 02/21/2020 Philips North America, LLC
Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI code... 2 02/19/2020 Philips North America LLC
Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017 2 02/19/2020 Philips North America LLC
Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist (Step) Drills, G... 2 02/19/2020 Nobel Biocare Usa Llc
Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting ... 2 01/30/2020 Arthrex, Inc.
2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - Product Usage:Sterile T... 2 01/29/2020 Synthes, Inc.
2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile T... 2 01/29/2020 Synthes, Inc.
2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile T... 2 01/29/2020 Synthes, Inc.
2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - Product Usage:Sterile T... 2 01/29/2020 Synthes, Inc.
2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile T... 2 01/29/2020 Synthes, Inc.
Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) 2 01/24/2020 Palodex Group Oy
Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036 2 01/21/2020 Polymer Technology Systems, Inc.
Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System and is used... 2 01/07/2020 Stryker GmbH
Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.T. CONTROL and S.M.A.R.... 2 12/20/2019 Cardinal Health 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 PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - Product Usage: pre-calibrated PSD... 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.
MICRO-PSD EXTERNAL BEAM PHOTON, Catalog Number: PSD-PE5N - Product Usage: pre-calibrated PSD sensors... 2 12/19/2019 Angiodynamics, Inc.
HeartStart XL+ Defibrillator/Monitor, Model 861290 2 12/05/2019 Philips North America, LLC
HeartStart XL+ Defibrillator/Monitor, Model 861290 2 11/19/2019 Philips North America, LLC
Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as... 2 11/15/2019 Angiodynamics Inc. (Navilyst Medical Inc.)
Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY ... 2 10/23/2019 Brainlab AG
OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting... 2 10/13/2019 OrthoPediatrics Corp
IV START KIT IV8440 2 10/09/2019 Centurion Medical Products Corporation
Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758 2 09/20/2019 Philips North America LLC
HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightw... 2 09/06/2019 Philips North America, LLC
Endotrac EPF/EGR Push Blade, Catalog Number 3053-1 The EPF system is designed for the treatment ... 2 08/28/2019 Stryker GmbH
Endintrak® 2 Hook Blade, Angled, Catalog Number 4058A-1 The EPF system is designed for the treat... 2 08/28/2019 Stryker GmbH
Endotrac EPF/EGR Hook Blade, Angled, Catalog Number 3055A-1 The EPF system is designed for the t... 2 08/28/2019 Stryker GmbH
Endotrac EPF/EGR Triangle Blade, Angled, Catalog Number 3054A-1 The EPF system is designed for t... 2 08/28/2019 Stryker GmbH
Endotrac ECTR Hook Blade, Angled, Catalog Number 2055A-1 The EPF system is designed for the trea... 2 08/28/2019 Stryker GmbH
Endotrac ECTR Triangle Blade, Angled, Catalog Number 2054A-1 The EPF system is designed for the ... 2 08/28/2019 Stryker GmbH
Endintrak 2 Hook Blade, Catalog Number 4058-1 The EPF system is designed for the treatment of pl... 2 08/28/2019 Stryker GmbH
Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is designed for the treatment ... 2 08/28/2019 Stryker GmbH
Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 The EPF system is designed for the treatm... 2 08/28/2019 Stryker GmbH
Endotrac ECTR Hook Blade, Catalog Number 2055-1 The EPF system is designed for the treatment of ... 2 08/28/2019 Stryker GmbH
Endotrac ECTR Triangle Blade, Catalog Number 2054-1 The EPF system is designed for the treatment... 2 08/28/2019 Stryker GmbH
Endotrac ECTR Push Blade, Catalog Number 2053-1 The EPF system is designed for the treatment of ... 2 08/28/2019 Stryker GmbH
Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed for the treatment of pl... 2 08/28/2019 Stryker GmbH
TransWarmer Warming Infant Transport Mattress, Model no. 20421 Product Usage: The TransWarmer® ... 2 08/24/2019 CooperSurgical, Inc.
The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly throug... 2 08/08/2019 Ra Medical Systems 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
Lantis Commander, Model # 4503178 - Product Usage: Lantis Treatstation is to allow the radiation t... 2 08/06/2019 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 system (pre-2003), Model #5835991 - Product Usage: Lantis Treatstation is to allow the radiat... 2 08/06/2019 Siemens Medical Solutions USA, Inc
SenTec Standard Starter Set with and without Service Gas (2 changers each) - Product Usage: Is indic... 2 08/05/2019 SenTec AG
SenTec Neonatal Starter Set with and without Service Gas (2 Chargers each) - Product Usage: is indic... 2 08/05/2019 SenTec AG
Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M353... 2 07/05/2019 Philips North America, LLC
Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution 2 07/05/2019 Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement. ... 2 06/19/2019 Zimmer Biomet, Inc.
2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: ... 3 06/01/2019 Fresenius Medical Care Renal Therapies Group, LLC
T7 Driver Solid AO (Part Number 110018541) Product Usage: The Biomet Headless Compression Screws... 2 05/09/2019 Zimmer Biomet, Inc.
T7 Driver Cannulated AO (Part Number 110018531) Product Usage: The Biomet Headless Compression S... 2 05/09/2019 Zimmer Biomet, Inc.
Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: ... 2 04/23/2019 Fenwal Inc
Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma... 2 04/09/2019 Beaver Visitec
Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B Product ... 2 03/27/2019 Accelerate Diagnostics Inc
Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas an... 2 03/26/2019 Randox Laboratories Ltd.
Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization du... 2 02/27/2019 Alcon Research Laboratories Ltd.
MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices 2 02/02/2019 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
VentStar Anesthesia WT(P) 180, Catalog Number MP00374 Breathing Circuits/Anesthesia Sets without... 1 01/24/2019 Draeger Medical, Inc.
VentStar Watertrap (P) 180, Catalog Number MP00361 Breathing Circuits/Anesthesia Sets without a ... 1 01/24/2019 Draeger Medical, Inc.
VentStar Basic (P) 250, Catalog Number MP00352 Breathing Circuits/Anesthesia Sets without a Wate... 1 01/24/2019 Draeger Medical, Inc.
VentStar Basic 180, Catalog Number MP00349 Breathing Circuits/Anesthesia Sets without a Water tr... 1 01/24/2019 Draeger Medical, Inc.
VentStar Basic 250, Catalog Number MP00350 Breathing Circuits/Anesthesia Sets without a Water tra... 1 01/24/2019 Draeger Medical, Inc.
VentStar Basic (P) 180, Catalog Number MP00351 Breathing Circuits/Anesthesia Sets without a Wate... 1 01/24/2019 Draeger Medical, Inc.
enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation f... 2 12/18/2018 Bausch & Lomb Surgical, Inc.
HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of Hear... 2 12/13/2018 Philips North America LLC
St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONL... 2 12/10/2018 St. Jude Medical, Inc.
CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable non-sterile bracket wi... 2 12/07/2018 CIVCO Medical Instruments Co., Inc.
CIVCO Needle Guide Starter Kit, REF numbers P12924-01 and P12924-02, Reusable non-sterile bracket wi... 2 12/07/2018 CIVCO Medical Instruments Co., Inc.
CIVCO Needle Guide Starter Kit, REF 674-037, Reusable non-sterile bracket with sterile needle guides... 2 12/07/2018 CIVCO Medical Instruments Co., Inc.
CIVCO Needle Guide Starter Kit, REF 674-038, Reusable non-sterile bracket with sterile needle guide ... 2 12/07/2018 CIVCO Medical Instruments Co., Inc.
CIVCO Needle Guide Starter Kit, REF 674-039, Reusable non-sterile bracket with sterile needle guides... 2 12/07/2018 CIVCO Medical Instruments Co., Inc.
CIVCO Needle Guide Starter Kit, REF numbers P12920-01 and P12920-02, Reusable non-sterile bracket w... 2 12/07/2018 CIVCO Medical Instruments Co., Inc.
Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Mode... 2 11/14/2018 Johnson & Johnson Surgical Vision Inc
BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare ... 2 10/31/2018 Becton Dickinson & Co.
BD Max Instrument, Catalog Number 441916 441927 (refurbished instrument) - Product Usage: The BD MAX... 2 10/31/2018 Becton Dickinson & Co.
Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is... 2 10/18/2018 Philips Electronics North America Corp.
OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label ... 2 10/03/2018 Johnson & Johnson Surgical Vision Inc
2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Up... 2 09/19/2018 Fresenius Medical Care Renal Therapies Group, LLC
2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium U... 2 09/19/2018 Fresenius Medical Care Renal Therapies Group, LLC
VidiStar(TM) PACS & DICOM Viewer Software system 2 09/06/2018 Hitachi Healthcare Americas Corp Informatics Division
2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component. S... 2 07/20/2018 IMPLANTCAST GMBH
AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog Number: FG-000150 The... 2 07/13/2018 AESDEX
AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000100. The Cardica C... 2 07/13/2018 AESDEX
microTargeting" STar" Drive System (Motorized), Product Number ST-DS-ME 2 07/05/2018 FHC, Inc.
microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA 2 07/05/2018 FHC, Inc.
microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME 2 07/05/2018 FHC, Inc.
microTargeting" Drive System, Product Number MT-DS-01 2 07/05/2018 FHC, Inc.
microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB 2 07/05/2018 FHC, Inc.
microTargeting" Drive System Distributed by Medtronic, Product Number FC1006 2 07/05/2018 FHC, Inc.
microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601 2 07/05/2018 FHC, Inc.
microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001 2 07/05/2018 FHC, Inc.
microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002 2 07/05/2018 FHC, Inc.
microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8), 2 07/05/2018 FHC, Inc.
microTargeting" Drive System, Product Number 66-ZD-MD 2 07/05/2018 FHC, Inc.
microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DB 2 07/05/2018 FHC, Inc.
microTargeting" Drive System, Product Number MT-DS 2 07/05/2018 FHC, Inc.
microTargeting" Drive System, Product Number 66-ZD-MD-01 2 07/05/2018 FHC, Inc.
microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA 2 07/05/2018 FHC, Inc.
VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use o... 2 06/29/2018 BioMerieux SA
Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 The power supply unit ... 2 06/29/2018 Toshiba American Medical Systems Inc
Part #: SAM XT-M, Model: Tactical Black or Military 2 06/14/2018 The Seaberg Company Inc
HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automate... 2 05/30/2018 Philips Electronics North America Corporation
Philips HeartStart FRx AED. 2 05/23/2018 Philips Electronics North America Corp.
Philips HeartStart (HS1) Onsite/Home AED 2 05/23/2018 Philips Electronics North America Corp.
iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated ... 2 05/18/2018 Beckman Coulter Inc.
Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cuttin... 2 05/14/2018 Coltene Whaledent Inc
LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Sho... 2 05/08/2018 DePuy Mitek, Inc., a Johnson & Johnson Co.
BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-771... 2 05/04/2018 Beckman Coulter Inc.
iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated ... 2 04/27/2018 Beckman Coulter Inc.
EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product Number HEM3335, ... 2 04/26/2018 Covidien LLC
EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 4.8MM, Product Number HEM3348, ... 2 04/26/2018 Covidien LLC
Crimson Trace Corporation laser sights. The Finished Products are laser sighting systems for fire... 2 04/23/2018 Crimson Trace Corporation
Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). ... 2 04/20/2018 Life Technologies Corporation
Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)1019030200607... 2 03/30/2018 Life Technologies Corporation
The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser i... 2 03/29/2018 SIE AG, Surgical Instrument Engineering
Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas Module 3 i... 3 03/28/2018 Mindray DS USA, Inc. dba Mindray North America
First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface o... 2 03/26/2018 Madison Polymeric Engineering
LATEX FREE IV START SET 2 03/17/2018 Centurion Medical Products Corporation
PEDIATRIC IV & IV START KIT 2 03/17/2018 Centurion Medical Products Corporation
NEONATAL IV START KIT 2 03/17/2018 Centurion Medical Products Corporation
IV START KIT 2 03/17/2018 Centurion Medical Products Corporation
HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting... 3 03/13/2018 Philips Electronics North America Corporation
Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administ... 2 03/09/2018 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
241-McKesson Premium Skin Staple Remover Kit, Item #100123, McKesson I.V. Start Kit, 100124-McKesson... 2 03/08/2018 Cypress Medical Products LLC
Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures 2 02/28/2018 B. Braun Medical, Inc.
Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter is intended for use with... 2 02/22/2018 Philips Electronics North America Corporation
Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with... 2 02/22/2018 Philips Electronics North America Corporation
Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alim... 2 02/21/2018 Ethicon Endo-Surgery Inc
OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The fir... 2 02/16/2018 Oculus Optikgeraete GMBH
MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: The H... 1 02/08/2018 Philips North America, LLC
bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Product Usage: Specialty bla... 2 02/01/2018 Beaver-Visitec International Inc.
bvi Beaver Xstar Safety Slit Knife: (a) REF 378214, 1.4mm, 45o Bevel Up (b) REF 378215, 1.50mm, ... 2 02/01/2018 Beaver-Visitec International Inc.
ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables... 2 01/14/2018 Philips Electronics North America Corporation
TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is inten... 2 12/26/2017 Accuray Incorporated
TomoH(R) System, Model Number 1018284 Product Usage: The TomoTherapy treatment system is intende... 2 12/26/2017 Accuray Incorporated
TomoHD(R) System, Model Number 1018283 Product Usage: The TomoTherapy treatment system is intend... 2 12/26/2017 Accuray Incorporated
Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy treatment system is int... 2 12/26/2017 Accuray Incorporated
Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, starter, Ref ST... 2 12/21/2017 Zimmer Dental Inc
Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator 2 12/21/2017 Philips Electronics North America Corporation
LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009 The defibrillation e... 1 12/12/2017 Physio-Control, Inc.
PENTARAY NAV High-Density Mapping Catheter. 2 12/07/2017 Biosense Webster, Inc.
PENTARAY NAV High-Density Mapping Catheter. 2 12/07/2017 Biosense Webster, Inc.
Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Densh... 2 12/06/2017 Fukuda Denshi Co., Ltd.
BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 ... 2 11/28/2017 Brainlab AG
AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx.... 2 11/08/2017 Aaren Scientific Inc.
North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. Industrial x-ray i... 2 11/06/2017 North Star Imaging Inc
IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw 2 09/22/2017 Deerfield Imaging
Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for in vitro diagnost... 2 09/12/2017 Leica Biosystems Richmond Inc.
LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic Microscope. LX3 Micr... 2 08/28/2017 Alcon Research, Ltd.
PALLAS M/MAXIMIS Set Screw Starter. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem S... 2 08/10/2017 Valorem Surgical LLC
PALLAS M/MAXIMIS Nut Driver 4.5 Star and Final Driver 4.0. Part of MAXIMIS Pedicle Screw Spinal Fixa... 2 08/10/2017 Valorem Surgical LLC
EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #: 321-45-01 2 07/03/2017 Exactech, Inc.
EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #: 321-25-01 2 07/03/2017 Exactech, Inc.
EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01 2 07/03/2017 Exactech, Inc.
DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarj... 2 06/20/2017 DePuy Mitek, Inc., a Johnson & Johnson Co.
DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet C... 2 06/20/2017 DePuy Mitek, Inc., a Johnson & Johnson Co.
DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product Usage: The Lata... 2 06/20/2017 DePuy Mitek, Inc., a Johnson & Johnson Co.
DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cor... 2 06/20/2017 DePuy Mitek, Inc., a Johnson & Johnson Co.
DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 Product Usage: The La... 2 06/20/2017 DePuy Mitek, Inc., a Johnson & Johnson Co.
Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of head struc... 2 05/31/2017 Elekta, Inc.
AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Slee... 2 05/16/2017 Abbott Medical Optics Inc. (AMO)
Cataract Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a convenient manner for u... 2 04/11/2017 Windstone Medical Packaging, Inc.
Cataract Kit - Dr. Slingsby, part number CMP1017(B. Product packaged in a convenient manner for use... 2 04/11/2017 Windstone Medical Packaging, Inc.
Cataract Pack, part numbers 008886-1, AMS2806, PSS3442, PSS3442(A, WAL1155, and WAL1155(A. Product ... 2 04/11/2017 Windstone Medical Packaging, Inc.
Eye Cataract Pack, part numbers AMS1359 and AMS1359-1 Product packaged in a convenient manner for u... 2 04/11/2017 Windstone Medical Packaging, Inc.
ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposab... 1 04/10/2017 Oscor, Inc.
ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Ser... 1 04/10/2017 Oscor, Inc.
Bond Elut OMS (Dried Matrix Spotting)' Product; Catalog model numbers: 5022-8226 - Auto DBS Card... 2 04/05/2017 Agilent Technologies, Inc.
XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targeted UVB phototherapy for ... 2 03/27/2017 Strata Skin Sciences, Inc.
HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M... 1 03/24/2017 Philips North America, LLC
StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. Th... 2 02/15/2017 Abbott Vascular
Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in... 2 01/09/2017 Alcon Research, Ltd.
K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm x 18, Part Number 9080... 2 12/22/2016 Amendia, Inc
MANOS EX (CAT#TY-12-101) Product Usage: Carpal Tunnel Release: as a tool for tissue release of t... 2 12/03/2016 Thayer Intellectual Property, Inc.
PeroxiClear Peroxide Solution, (3oz. and 12 oz., 12 oz. Twin Pack, 2x12 oz. Twin Pack for Target sto... 2 11/21/2016 Bausch & Lomb Inc Irb
Phoenix Recon Targeting Arm Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgic... 2 10/14/2016 Zimmer Biomet, Inc.
Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016). ... 2 10/13/2016 Varian Medical Systems, Inc.
Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring dental porcelain 2 10/04/2016 Ivoclar Vivadent, Inc.
Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring dental porcelain 2 10/04/2016 Ivoclar Vivadent, Inc.
Zenostar MT Color C3 60ml, art. no. 681061. Product Usage: For coloring dental porcelain 2 10/04/2016 Ivoclar Vivadent, Inc.
Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring dental porcelain 2 10/04/2016 Ivoclar Vivadent, Inc.
Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain 2 10/04/2016 Ivoclar Vivadent, Inc.
Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring dental porcelain 2 10/04/2016 Ivoclar Vivadent, Inc.
Zenostar MT Color C1 60ml, art. no. 681059. Product Usage: For coloring dental porcelain 2 10/04/2016 Ivoclar Vivadent, Inc.
Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring dental porcelain 2 10/04/2016 Ivoclar Vivadent, Inc.
Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelain 2 10/04/2016 Ivoclar Vivadent, Inc.
Zenostar MT Color B2 60ml, art. no. 681056. Product Usage: For coloring dental porcelain 2 10/04/2016 Ivoclar Vivadent, Inc.
Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring dental porcelain 2 10/04/2016 Ivoclar Vivadent, Inc.
Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelain 2 10/04/2016 Ivoclar Vivadent, Inc.
Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For coloring dental porcelain 2 10/04/2016 Ivoclar Vivadent, Inc.
Zenostar MT Color A3 60ml, art. no. 681052. Product Usage: For coloring dental porcelain 2 10/04/2016 Ivoclar Vivadent, Inc.
Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring dental porcelain 2 10/04/2016 Ivoclar Vivadent, Inc.
Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain 2 10/04/2016 Ivoclar Vivadent, Inc.
Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain ... 2 10/04/2016 Ivoclar Vivadent, Inc.
Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain 2 10/04/2016 Ivoclar Vivadent, Inc.
Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelai... 2 10/04/2016 Ivoclar Vivadent, Inc.
Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain 2 10/04/2016 Ivoclar Vivadent, Inc.
Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain 2 10/04/2016 Ivoclar Vivadent, Inc.
VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excision... 2 09/30/2016 New Star Lasers, Inc.
CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermat... 2 09/30/2016 New Star Lasers, Inc.
TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The product is indicated for p... 2 09/21/2016 Abbott Medical Optics Inc. (AMO)
TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is indicated primary impla... 2 09/21/2016 Abbott Medical Optics Inc. (AMO)
SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is indicated for implantation... 2 09/21/2016 Abbott Medical Optics Inc. (AMO)
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002 The product is indicated ... 2 09/21/2016 Abbott Medical Optics Inc. (AMO)
TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; The product is indicated for p... 2 09/21/2016 Abbott Medical Optics Inc. (AMO)
TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00V The p... 2 09/21/2016 Abbott Medical Optics Inc. (AMO)
TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00 The product is i... 2 09/21/2016 Abbott Medical Optics Inc. (AMO)
SENSAR 1-Piece IOL, Model No. AAB00 The product is indicated for implantation for the visual correc... 2 09/21/2016 Abbott Medical Optics Inc. (AMO)
TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product is indicated for impla... 2 09/21/2016 Abbott Medical Optics Inc. (AMO)
TECNIS 1-Piece IOL, Model No. ZCB00 The product is indicated for implantation for the visual correc... 2 09/21/2016 Abbott Medical Optics Inc. (AMO)
HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A 2 09/19/2016 Philips Electronics North America Corporation
Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage: The Alcon AcrySof IQ Intraocu... 2 09/01/2016 Alcon Research, Ltd.
OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL... 2 08/18/2016 Nidek Inc
Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 c... 2 08/12/2016 Baxter Healthcare Corp.
Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titaniu... 2 08/11/2016 Synthes (USA) Products LLC
Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 30... 1 08/04/2016 Draeger Medical, Inc.
Part # 313.232, 2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC, lot # 4363820, mfg. 9/11/2... 2 07/12/2016 Synthes (USA) Products LLC
Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341031, 4363779, 44... 2 07/12/2016 Synthes (USA) Products LLC
Part # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC, Lot # 4363780, mfg. 9/18/20... 2 07/12/2016 Synthes (USA) Products LLC
Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 4589566, 470... 2 07/12/2016 Synthes (USA) Products LLC
Part #313.231, 2.0mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341036, 4363819, 442... 2 07/12/2016 Synthes (USA) Products LLC
Target Detachable Coils: TARGET HELICAL NANO 2MM X 6CM MODEL Number:M0035452060 Neurolo... 2 07/11/2016 Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 3CM MODEL Number:M0035452530 Neurology: ... 2 07/11/2016 Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 4CM MODEL Number:M0035452540 Neurology: ... 2 07/11/2016 Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M0035452560 Neurology: Targ... 2 07/11/2016 Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M0035453040 Neurology: Ta... 2 07/11/2016 Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 3MM X 6CM MODEL Number:M0035453060 Neurology: Ta... 2 07/11/2016 Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 3MM X 8CM MODEL Number:M0035453080 Neurology: Ta... 2 07/11/2016 Stryker Neurovascular
Target Detachable Coils: TARGET 360 NANO 1 MM X 2 CM MODEL Number: M0035421020 Neurology: Targe... 2 07/11/2016 Stryker Neurovascular
Target Detachable Coils: TARGET 360 NANO 1 MM X 3 CM MODEL Number: M0035421030 Neurology: Targe... 2 07/11/2016 Stryker Neurovascular
Target Detachable Coils: TARGET 360 NANO 1.5 MM X 2 CM MODEL Number: M0035421520 Neurology: Tar... 2 07/11/2016 Stryker Neurovascular
Target Detachable Coils: TARGET 360 NANO 1.5 MM X 3 CM MODEL Number: M0035421530 Neurology: Tar... 2 07/11/2016 Stryker Neurovascular
Target Detachable Coils: TARGET 360 NANO 1.5 MM X 4 CM MODEL Number:M0035421540 Neurology: Targ... 2 07/11/2016 Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 1 MM X 1 CM MODEL Number:M0035431010 Neurology: Ta... 2 07/11/2016 Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 1 MM X 2 CM MODEL Number:M0035431020 Neurology: ... 2 07/11/2016 Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 1 MM X 3 CM MODEL Number:M0035431030 Neurology... 2 07/11/2016 Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 1 CM MODEL Number:M0035431510 Neurology: ... 2 07/11/2016 Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 2 CM MODEL Number:M0035431520 Neurology... 2 07/11/2016 Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 3 CM MODEL Number:M0035431530 Neurology... 2 07/11/2016 Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 4 CM MODEL Number:M0035431540 Neurology: ... 2 07/11/2016 Stryker Neurovascular
Target Detachable Coils: TARGET 360 NANO 2MM X 3CM MODEL Number:M0035442030 Neurology: Target... 2 07/11/2016 Stryker Neurovascular
Target Detachable Coils: TARGET 360 NANO 2MM X 4CM MODEL Number:M0035442040 Neurology: Target... 2 07/11/2016 Stryker Neurovascular
Target Detachable Coils: TARGET 360 NANO 2.5 MM X 4CM MODEL Number:M0035442540 Neurology: Tar... 2 07/11/2016 Stryker Neurovascular
Target Detachable Coils: TARGET 360 NANO 3MM X 4CM MODEL Number:M0035443040 Neurology: Target... 2 07/11/2016 Stryker Neurovascular
Target Detachable Coils: TARGET 360 NANO 3MM X 6CM MODEL Number:M0035443060 Neurology: Target... 2 07/11/2016 Stryker Neurovascular
Target Detachable Coils: TARGET 360 NANO 3.5 MM X 6CM MODEL Number:M0035443560 Neurology: Tar... 2 07/11/2016 Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 2MM X 2CM MODEL Number:M0035452020 Neurology: ... 2 07/11/2016 Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 2MM X 3CM MODEL Number:M0035452030 Neurology... 2 07/11/2016 Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 2MM X 4CM MODEL Number:M0035452040 Neuro... 2 07/11/2016 Stryker Neurovascular
PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex ... 2 07/06/2016 Medtronic Navigation
Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro diagnostic use. HER... 2 06/29/2016 Dako North America Inc.
HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricul... 2 06/02/2016 Philips Electronics North America Corporation
LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surger... 2 05/17/2016 Alcon Research, Ltd.
INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 806575172... 2 05/03/2016 Alcon Research, Ltd.
Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128... 2 04/29/2016 Biosense Webster, Inc.
Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205,... 2 04/29/2016 Biosense Webster, Inc.
Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for st... 2 04/22/2016 Elekta, Inc.

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