9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Cytal® Wound Matrix; Cytal® Burn Matrix
FDA 510(k)
FDA Unclassified
·Unknown
TRIAL INSERT D.46 REPLACE CUP HOLDERS
FDA UDI
FOURNITURES HOSPITALIERES INDUSTRIE·03661489417245·
MiniSPC Button
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071152703·24F x 1.7cm MiniSPC Low Profile Suprapubic Cath...
COMPASS M10 SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK
FDA 510(k)
FDA Class 2
·Dental
COAGUCHEK® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·September 9, 2011
GORE-TEX SUTURE
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code GAW·November 20, 2008
UNKNOWN DEPUY ASR ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·July 22, 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