11 results
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22ms
·
Sources: EU EUDAMED, US FDA
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