9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat
FDA 510(k)
FDA Class 2
·Radiology
COMPRESSION ANASTOMOSIS CLIP (CAC)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR
FDA 510(k)
FDA Class 2
·Cardiovascular
PROTECT SLEEVE 16/11 F/PFNA BLADE
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code HWE·August 26, 2014
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HRS·November 10, 2014
MINI-CAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 9, 2011
ASR ACETABULAR CUPS 48
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·July 22, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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