12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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UNISTRIP 1
FDA 510(k)
FDA Class 2
·Clinical Chemistry
JOBST forMen Casual
FDA UDI
BSN MEDICAL, INC.·00035664131357·FOR MEN CASUAL 30-40 MM HG KNEE HIGH CLOSED TOE...
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK113151·DD tempMED are pre-colored dental milling blank...
POLARCUP DUAL MOBILITY SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS)
FDA 510(k)
FDA Class 2
·Immunology
T:SLIM G4 SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code OYC·January 10, 2018
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 20, 2011
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 22, 2014
MASTER CARE
FDA Adverse Event
Injury
·MASTER CARE·Product code FNL·November 8, 2006
STYLE 68 SALINE FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·April 22, 2021
OT VERIO IQ METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 9, 2016
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021