8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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H-FLU B ELISA TEST
FDA 510(k)
FDA Class 2
·Microbiology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471201224·RECIP. BLADE - DE SOUTTER MICRO 6.4 x 33.5 x 0....
VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack
FDA 510(k)
FDA Class 2
·Immunology
SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
FDA 510(k)
FDA Class 3
·Cardiovascular
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 25, 2014
ASR XLA M/L SLEEVE 12/14 +2
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 14, 2012
COLLEAGUE CXE VOLUMETRICINFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 10, 2010
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