9 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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trophon Wireless Ultrasound Probe Holder
FDA 510(k)
FDA Class 2
·Radiology
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221049698·Unitek(TM) Permachrome Standard Stainless Steel...
Infrared Forehead Thermometer
FDA 510(k)
FDA Class 2
·General Hospital
VIEWING CLIENT MOBILE
FDA 510(k)
FDA Class 2
·Radiology
INJECTOR, OPTIVANTAGE DH
FDA Adverse Event
Injury
·LIEBEL-FLARSHEIM CO.·Product code IZQ·November 21, 2008
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·August 9, 2011
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
Malfunction
·INVAMEX·Product code ILS·July 22, 2013
AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24 mm). For orthopedic use in ligament reconstruction.
FDA Enforcement
Class II
·Terminated·Cayenne Medical Inc.·July 18, 2018
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