10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CELERITY HP Indicator Tape
FDA 510(k)
FDA Class 2
·General Hospital
Philips
FDA UDI
Sbo Hearing A/S·05714464058488·HEARLINK 3030 MNR T DG
MODIFICATION TO URETERAL STENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BONASTENT BILIARY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178404
FDA Enforcement
Class II
·Ongoing·Biomet, Inc.·November 29, 2023
ATLAS II PLUS HF CRT-D
FDA Adverse Event
Death
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·November 10, 2014
VISX STAR S4
FDA Adverse Event
Injury
·VISX·Product code LZS·September 3, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 22, 2013
ATTUNE FB TIB BASE SZ 4 CEM
FDA Adverse Event
Malfunction
·DEPUY IRELAND - 9616671·Product code JWH·October 17, 2023
CERTAIN GOLD-TITE HEXED SCREW
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·March 16, 2021