10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Powered Wheelchair (NXN20-208, NXN20-211)
FDA 510(k)
FDA Class 2
·Physical Medicine
NYOrtho APEX CORE Wheelchair Cushion Gel-Foam 24x16x3
FDA UDI
N.Y. ORTHOPEDIC USA, INC.·00811677018751·The NYOrtho APEX CORE Gel-Foam Cushion combines...
ACETABULAR REAMER D.52
FDA UDI
FOURNITURES HOSPITALIERES INDUSTRIE·03661489416033·
Acetabular reamer ø52mm
FDA UDI
Incipio Devices SA·07630055301567·Acetabular reamer for hip arthroplasty
Ultra Silver Dressings
FDA 510(k)
FDA Unclassified
·Unknown
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses
FDA 510(k)
FDA Class 2
·Ophthalmic
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·November 20, 2008
SYSTEM 6 ASEPTIC HOUSING ASSY
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·September 2, 2011
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL 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