7 results
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31ms
·
Sources: EU EUDAMED, US FDA
MULTI-PROBE HEAD PLUS
FDA 510(k)
FDA Class 1
·Microbiology
12SL ECG ANALYSIS PROGRAM
FDA 510(k)
FDA Class 2
·Cardiovascular
PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
FDA 510(k)
FDA Class 2
·Hematology
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code ITI·June 24, 2014
6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code MGB·October 27, 2010
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 27, 2012
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