12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INSTANT-VIEW TROPONIN I TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814244·GENUMEDI PT SILVER L VII
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809871449·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND CLOSED...
TABLETOP SHIELD
FDA UDI
BIODEX MEDICAL SYSTEMS, INC.·00718175002278·Shield, Tabletop, Side, .25" Lead
MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1
FDA 510(k)
FDA Class 2
·Radiology
WANDY SILICONE CONDUCTIVE RUBBER PAD
FDA 510(k)
FDA Class 2
·Neurology
STRATA II, UNITIZED SHUNT, SMALL, 11.5CM
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·April 4, 2013
SMARTTEMP
FDA Adverse Event
Other
·KAZ, INC.·Product code IME·March 30, 2011
CONTAK RENEWAL 4 RF
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008
BD BACTO AGAR
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code JSK·January 27, 2021
UNK - NAIL HEAD ELEM: TFNA
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HSB·April 7, 2025
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024