8 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ATLAS Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
VICOR PD2I ANALYZER
FDA 510(k)
FDA Class 2
·Cardiovascular
ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FLOSEAL
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code LMF·March 20, 2024
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
FDA Adverse Event
Malfunction
·STAAR SURGICAL CO.·Product code HQL·October 1, 2008
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·June 26, 2013
ZOOM CRITICAL CARE BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·July 29, 2011
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