10 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENDOBOOT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704282948·LANGENBECK RETRACTOR 3/8"x1 1/2"
OTELO LL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
EYE SEE MULTIPURPOSE, NO-RUB CONTACT LENS SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
LIBERTY POSTERIOR SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·July 29, 2014
3.0MM CANNULATED SCREW LONG THREAD/34MM
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWC·February 19, 2013
TALENT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·February 8, 2013
EXPRESS LD ILIAC/BILIARY PREMOUNTED STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIO·January 6, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 22, 2014
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024