8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TOTAL PERFORMANCE SYSTEM SHAVER
FDA 510(k)
FDA Class 2
·Orthopedic
artegral HD
FDA UDI
Merz Dental GmbH·D7091973195·posteriors; shade BL4; size M; lower jaw
DRI Hydrocodone Assay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SCHNEIDER-SHILEY ANGIOPORT(TM) PTCA INTRO W/HEMO
FDA 510(k)
FDA Class 2
·Cardiovascular
COULTER® ACT DIFF 2 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·February 21, 2013
CARPENTIER EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·Product code DYE·January 28, 2011
CAPD DISCONNECT Y SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 1, 2014
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024