13 results
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18ms
·
Sources: EU EUDAMED, US FDA
SPACER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
OPUS RUBELLA TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
ANGIOGRAPHIC BALLOON CATHETER BY J LLOYD
FDA 510(k)
FDA Class 2
·Cardiovascular
EWIS BLUE 60/6 HCAP 5-PACK
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 29, 2024
EWIS BLUE 60/6 HCAP 5-PACK
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 29, 2024
FREEDOM CONSTR HD 36MM T1 -6MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWZ·June 20, 2019
TAPERLOC MICRO LAT FMRL 13.5MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·June 20, 2019
ASR ACETABULAR CUPS 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 22, 2013
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·November 8, 2010
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 10, 2014
REGENEREX (TM) RINGLOC MULTI HOLE ACETABULAR CUP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·August 27, 2018
M2A MAGNUM MODULAR HEAD 52MM HEAD DIAMETER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·November 18, 2016
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024