11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Electrode Pad
FDA 510(k)
FDA Class 2
·Neurology
ELMED
FDA UDI
ELMED INCORPORATED·00842180158986·MULTI - FLEX HANDREST, ATTACHES TO SHORT COUPLER
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776190996·Handrest Attaches to Short Coupler
Tiger Shark System
FDA UDI
Choice Spine, LP·00840996166089·TIGER SHARK,STERILE,STR,9X24X15,12 DEG
MiniSPC Button
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071152673·24F x 1.5cm MiniSPC Low Profile Suprapubic Cath...
VISIONAIRE UK Patient Matched Cutting Guides
FDA 510(k)
FDA Class 2
·Orthopedic
NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LUMAX 340 DR-T
FDA Adverse Event
Injury
·BIOTRONIK GMBH & CO.·Product code MRM·November 20, 2008
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 9, 2011
LOCKING SCREWS, CROSS-PIN, DIAM.2.0X14MM, (5/PACKAGE)
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS-FREIBURG·Product code JEY·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