11 results
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26ms
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Sources: EU EUDAMED, US FDA
V.A.D. ACCESS KIT
FDA 510(k)
FDA Class 2
·General Hospital
LP Low Profile
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746088834·DB BKT LP NARROW LOWER ANT 018 T-6 A=0 R=0
ASNIS
FDA UDI
Stryker GmbH·04546540534330·Lid for Screw Rack
LEONE SPA
FDA UDI
LEONE SPA·08033707066804·ELASTIC LIGATURES TRANSP 1,0mm
Sapphire ULTRA Coronary Dilatation Catheter
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955979361·
VIDAS C DIFFICILE GDH
FDA 510(k)
FDA Class 1
·Microbiology
GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERILE
FDA 510(k)
FDA Class 1
·General Hospital
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·January 28, 2013
CONSULTA
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code NIK·December 17, 2010
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 14, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021