10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VERSA Negative Pressure Wound Therapy System (VCMPP-100)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LCP
FDA UDI
Synthes GmbH·10886982165602·3.5MM LCP T-PLATE 3H HEAD/ 6H SHAFT/85MM-OBLIQU...
SKYHAWK
FDA UDI
Orthofix US LLC·18257200108879·AWL SLEEVE
Portex
FDA UDI
ICU MEDICAL, INC.·15019517083071·
REMOTEYE VIEWER
FDA 510(k)
FDA Class 2
·Radiology
D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS
FDA 510(k)
FDA Class 2
·Cardiovascular
PUMP MMT-712WWP PRDGM INSULIN PL EN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·November 21, 2008
MANTIS REDUX TORQUE WRENCH
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code LXH·August 17, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 18, 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