18 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FLNT Base and FLNT Temp
FDA 510(k)
FDA Class 2
·Dental
M/DN®
FDA UDI
Zimmer, Inc.·00889024044821·
M/DN®
FDA UDI
Zimmer, Inc.·00889024044814·
M/DN®
FDA UDI
Zimmer, Inc.·00889024044838·
M/DN®
FDA UDI
Zimmer, Inc.·00889024044845·
M/DN®
FDA UDI
Zimmer, Inc.·00889024044876·
M/DN®
FDA UDI
Zimmer, Inc.·00889024044883·
M/DN®
FDA UDI
Zimmer, Inc.·00889024044869·
M/DN®
FDA UDI
Zimmer, Inc.·00889024044807·
M/DN®
FDA UDI
Zimmer, Inc.·00889024044852·
M/DN®
FDA UDI
Zimmer, Inc.·00889024044890·
Seiva
FDA UDI
SUNTECH MEDICAL, INC.·10840935109990·
Disposable Surgical Face Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENDO GIA ROTICULATOR 60-3.5 SULU
FDA Adverse Event
Injury
·NORTH HAVEN - USS·Product code GDW·December 2, 2008
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·August 3, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·July 29, 2013
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014