117 results · 20ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended for the qualitative detection of IgM class antibodies to human Parvovirus B19 in human serum including women of childbearing age where there is a suspicion of exposure to human Parvovirus B19.

FDA Recall
Terminated ·Zeus Scientific, Inc.·Product code MYM·August 12, 2019

VIDAS Lyme IgG II (LYM), REF 417401

FDA Recall
Open, Classified ·bioMerieux, Inc.·Product code LSR·September 22, 2021

VIDAS Lyme IgM II (LYM), REF 416436

FDA Recall
Open, Classified ·bioMerieux, Inc.·Product code LSR·September 22, 2021

Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual: ACTIV5 USER MANUAL Welcome to Activ5, the first isometrics-based smart strength training and rehabilitation device.

FDA Recall
Open, Classified ·Activbody, Inc.·Product code LBB·November 30, 2021

MIM software; System, Image Processing, Radiological

FDA Recall
Open, Classified ·MIM Software Inc·Product code LLZ·February 19, 2025

Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.

FDA Recall
Terminated ·Oxford Immunotec·Product code OJN·July 16, 2020

Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.

FDA Recall
Terminated ·Oxford Immunotec·Product code OJN·July 16, 2020

Cosmetic color soft contact lenses. Multiple colors which include Blue, Green, Aqua, Brown, Grey. BesCon (brand)

FDA Recall
Terminated ·My Cosmetics Inc·Product code LPL·November 13, 2002

The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.

FDA Recall
Open, Classified ·IN MY BATHROOM LLC·Product code RHP·January 27, 2022

SpeedPass Disposable Suture Lariat with Nitinol Wire 45 Degree Up, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile. Part number 904008. Used to pass suture through tissue.

FDA Recall
Terminated ·Biomet, Inc.·Product code MDM·June 18, 2010

Stryker 9 MM AVS TL Trial Spacer; Catalog number: 48389409. Manufactured by: Stryker Spine SAS, Cestas, France; Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401. Intended for use in the thoraco-lumbar spine.

FDA Recall
Terminated ·Stryker Spine·Product code MDM·May 13, 2010

FlexTrayTM Endopath Bariatric Tray, Kit Code TBW70S.

FDA Recall
Terminated ·Ethicon Endo-Surgery·Product code MDM·December 15, 2004

Endopath 5 mm Babcocks with Ratchet Handles (product code 5BB).

FDA Recall
Terminated ·Ethicon Endo-Surgery·Product code MDM·December 15, 2004

FlexTrayTM Endopath Cholecsystectomy Tray, Kit Code TNC06.

FDA Recall
Terminated ·Ethicon Endo-Surgery·Product code MDM·December 15, 2004

FlexTrayTM Endopath Cholecsystectomy Tray, Kit code FDC21

FDA Recall
Terminated ·Ethicon Endo-Surgery·Product code MDM·December 15, 2004

Proximate Linear Cutter with Safety Lock-Out, Reloadable, contains 100 titanium staples with integral knife, Product No. TCT10, staple size: 3 mm x 4.5 mm.

FDA Recall
Terminated ·Ethicon Endo-Surgery·Product code MDM·May 21, 2003

Proximate Linear Cutter with Safety Lock-Out, reloadable, contains 100 titanium staples with integral knife, Product No. #TLC10, staple size: 3 mm x 3.85 mm.

FDA Recall
Terminated ·Ethicon Endo-Surgery·Product code MDM·May 21, 2003

Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth of the implant well and appropriate positions for tie down holes

FDA Recall
Terminated ·Cochlear Americas Inc.·Product code MCM·June 5, 2015

AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.

FDA Recall
Terminated ·Advanced Bionics, LLC·Product code MCM·February 17, 2020

HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.

FDA Recall
Terminated ·Advanced Bionics, LLC·Product code MCM·March 18, 2019