11 results
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19ms
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Sources: EU EUDAMED, US FDA
Ruthless Spine RJB
FDA 510(k)
FDA Class 2
·Orthopedic
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551313640·Irrigation Tube, 60K
Vu ePOD™
FDA UDI
Seaspine Orthopedics Corporation·10889981048853·26mm Trial, 5 Deg, 15 mm
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011252615200·ceraMotion® Me 3D Dentin CC3+1, 20 g / dental c...
MEDISIZE GOLD
FDA 510(k)
FDA Class 2
·Anesthesiology
Vonflex S
FDA 510(k)
FDA Class 2
·Dental
NA
FDA UDI
Exactech, Inc.·10885862552228·TRIAL, TIBIAL SPACER, SIZE 0, 15 mm
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 15, 2014
IVT DISPOSABLES
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code KPE·September 18, 2011
LIGASURE ATLAS HANDSWITCHING 20CM
FDA Adverse Event
Malfunction
·COVIDIEN LLC (SHANGHAI)·Product code GEI·July 15, 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