94 results · 25ms · 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.

TRISTAR BONE GRAFT FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

Biomet® Knee System

FDA UDI
Biomet Orthopedics, LLC·00880304232846·

CHARTIS CONSOLE

FDA 510(k)
FDA Class 2 ·Anesthesiology

THE VITROS 5,1 FS CHEMISTRY SYSTEM

FDA 510(k)
FDA Class 2 ·Hematology

UNKNOWN FEMORAL AUGMENTS

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·December 30, 2019

VNGD SSK INTLK FMRL 70 LT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·December 30, 2019

UNKNOWN FEMORAL AUGMENTS

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·December 30, 2019

UNKNOWN FEMORAL AUGMENT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·December 30, 2019

BIOMET OFFSET TIBIAL TRAY 75MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·December 30, 2019

VNGD SSK PSC TIB BRG 22X71/75 5 X 22

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·December 30, 2019

UNKNOWN FEMORAL AUGMENTS

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·December 30, 2019

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 4, 2014

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·June 27, 2011

Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, REF 24640. Product Usage: The test kit is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal specimens. The test is intended for use as an aid in diagnosis of Clostridium difficile-associated disease.

FDA Enforcement
Class II ·Terminated·Remel Inc·February 20, 2013

AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE

FDA Adverse Event
Malfunction ·COOK INC·Product code DQX·April 15, 2021

UNKNOWN

FDA Adverse Event
Injury ·COOK INC·Product code DQX·July 2, 2024

BENTSON STRAIGHT FIXED CORE WIRE GUIDE

FDA Adverse Event
Malfunction ·COOK INC·Product code DQX·August 12, 2024

AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE

FDA Adverse Event
Malfunction ·COOK INC·Product code DQX·April 25, 2022

SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE

FDA Adverse Event
Malfunction ·COOK INC·Product code DQX·May 3, 2024