7 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PER-Q-CATH MID-LINE
FDA 510(k)
FDA Class 2
·General Hospital
DEVICES FOR VASCU INTERVENT ROTAT HEMOSTAT VALVE
FDA 510(k)
FDA Class 2
·Cardiovascular
SERIES 25 SLIMLINE CRYO PROBES
FDA 510(k)
FDA Class 2
·Ophthalmic
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·February 11, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 24, 2014
PFC SIGMA CRVD INSERT SZ3 10MM
FDA Adverse Event
Injury
·DEPUY RAYNHAM·Product code JWH·January 5, 2011
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024