11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Hintermann Series H2 Total Ankle System
FDA 510(k)
FDA Class 2
·Orthopedic
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017989·K-Wire, Single Ended, Trocar Point, Diameter Si...
ORTHOFIX
FDA UDI
ORTHOFIX SRL·18059015375411·REVISION LOCKING SCREW L47.5MM D4.0MM
ORTHOFIX
FDA UDI
ORTHOFIX SRL·18059015374919·REVISION LOCKING SCREW L47.5MM D4.0MM STERILE
ROTATING ADAPTERS
FDA 510(k)
FDA Class 2
·Cardiovascular
MICROMAX SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
ACCENT SR RF OUS
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·September 9, 2011
8010042-2008-00124
FDA Adverse Event
Malfunction
·Product code CBK·August 26, 2008
1MM COARSE DIAMOND BALL
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 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