11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
NEEDLE-GRABBER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111086·INSTRUMENT CASE LARGE ALUMINUM
ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CONNECT FOR DA VINCI SURGICAL SYSTEM(S)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VANGUARD KNEE SERIES A STANDARD PATELLA
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·September 12, 2018
VANGUARD TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·September 11, 2018
BIOMET CC TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·September 12, 2018
ETS FLEX ARTICNG LNR CUTR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·January 22, 2013
ASR 300 SPIKED CUP SIZE 60
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·December 8, 2010
QUARTET
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·July 9, 2014
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024