9 results
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27ms
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Sources: EU EUDAMED, US FDA
METICULY Patient-specific titanium mesh implant
FDA 510(k)
FDA Class 2
·Neurology
LINK Instruments - Sterilization container and trays
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575337064·Sterilization/disinfection container - Endo Mod...
INEX Absorbable Nasal Implant
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
COLOR NIO 2MP, E-2320 C
FDA 510(k)
FDA Class 2
·Radiology
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·September 9, 2011
S-ICD SYSTEM
FDA Adverse Event
Injury
·CAMERON HEALTH·Product code LWS·November 12, 2014
XMAX MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code ERL·July 29, 2013
PLATE CHROMAGAR CANDIDA II 20 EA
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JSI·November 24, 2021
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