9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FLAT FIT-IN SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
STERLING SL MONORAIL PTA BALLOON DILATATION CATHETERS STERLING SL OVER-THE-WIRE BALLOON DILATATION CATHETERS MODEL VARIO
FDA 510(k)
FDA Class 2
·Cardiovascular
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 7, 2013
NEXGEN LEGACY LPS-FLEX ARTICULAR SURFACE
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code MBH·January 13, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·October 22, 2024
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·September 17, 2024
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024