11 results · 22ms · 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.

CHOLESTEROL DETERMINATION

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

CoRoent

FDA UDI
Nuvasive, Inc.·00887517160089·CoRoent® XLF, 12x18x60mm 10°

LINEAR ACCELERATOR G-2900

FDA 510(k)
FDA Class 2 ·Radiology

HERMES BOND 3

FDA 510(k)
FDA Class 2 ·Dental

MODULAR HYBRID GLENOID POST¿REGENEREX

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWS·October 12, 2018

MODULAR HYBRID GLENOID BASE

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWS·October 12, 2018

PFC SIGMARP STB TB IN 3 10.0

FDA Adverse Event
Injury ·DEPUY (IRELAND) 9616671·Product code NJL·June 13, 2014

UNKNOWN PRODUCT-RIGHT TRIATHLON KNEE

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS LIMERICK·Product code JWH·October 13, 2010

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 12, 2012

BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·October 25, 2017