7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)
FDA 510(k)
FDA Class 2
·Neurology
SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21
FDA 510(k)
FDA Class 3
·Cardiovascular
CLINISCANSM EEG
FDA 510(k)
FDA Class 2
·Neurology
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0 CM NON US
FDA Adverse Event
Malfunction
·COSTA RICA·Product code LTI·November 18, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·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