FDA Medical Devices

Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101

ASPEN SURGICAL

COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator

Medtronic Inc.

Critical Jul 3, 2024

SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 4535673…

Philips North America Llc

EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator

Medtronic Inc.

AXIOM MULTIX MP - Inended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic d…

Siemens Medical Solutions USA, Inc

MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP S…

Siemens Medical Solutions USA, Inc

Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid…

Roche Diabetes Care, Inc.

Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to prevent and/or treat pressure …

Baxter Healthcare Corporation

PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tis…

Ethicon, Inc.

MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated…

Ethicon, Inc.

VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but no…

Ethicon, Inc.

OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM

Exactech, Inc.

OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38…

Exactech, Inc.

Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910

Howmedica Osteonics Corp.

PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsur…

Ethicon, Inc.

Critical Jun 26, 2024

ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide (QRGs) as follows: Part Number…

ZOLL Medical Corporation

VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, c…

Ethicon, Inc.

HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900

Howmedica Osteonics Corp.

Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227

Beaver Visitec International, Inc.

Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10

Wondfo USA Co Ltd

Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) Clarity Di…

Wondfo USA Co Ltd

OMTech Desktop Laser Engraver

Rygel Advanced Machines d/b/a Omtech Laser

Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at Home Medical LLC, Areta One Step Strep…

Wondfo USA Co Ltd

Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.

B Braun Medical Inc

EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only

Covidien, LLC

Low Jun 19, 2024

NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange NonSterile, Product Code BC-S05EO…

Avanos Medical, Inc.

Aeos Robotic Digital Microscope, Product Code: PV010

Aesculap Inc

Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS Catalog Number: 1159851 Cardinal Catalog…

Mckesson Medical-Surgical Inc. Corporate Office

MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MRT-3010 (ME…

Canon Medical System, USA, INC.

Low Jun 19, 2024

NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSterile, Product Code BA-S05EO…

Avanos Medical, Inc.

CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundarie…

Blue Belt Technologies, Inc

Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biotech Co., Ltd, Wondfo One Step …

Wondfo USA Co Ltd

Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260

B Braun Medical Inc

Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse

Young Dental Manufacturing I, LLC

The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diam…

Stryker Neurovascular

ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020

MEDLINE INDUSTRIES, LP - Northfield

HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732

Philips North America Llc

ADVANTA VXT, 6X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

ADVANTA VXT, 7X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft

Atrium Medical Corporation

ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft

Atrium Medical Corporation

FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as a power supply alone.

Newport Corp

ADVANTA VXT, 7X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to monitor, display and record …

Nihon Kohden America Inc

ADVANTA VXT, 7X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

Critical Jun 12, 2024

Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS

ARROW INTERNATIONAL Inc.

FLIXENE, 6X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000

Medtronic Navigation, Inc.-Littleton