9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PILLAR SA Ti Spacer System (82-XXX)
FDA 510(k)
FDA Class 2
·Orthopedic
Sonic
FDA UDI
Sbo Hearing A/S·05714464057443·SONIC RADIANT 20 MNR T BE/TP
INFINITY TOTAL ANKLE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MODULAR REPLACEMENT SYSTEM CEMENTED STEMS
FDA 510(k)
FDA Class 2
·Orthopedic
QUADRA ASSURA CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·November 10, 2014
GENESYS HTA PROCERVA PROCEDURE SETS
FDA Adverse Event
Injury
·NORTH AMERICAN STERILIZATION &·Product code MNB·September 9, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·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