10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ceramic Femoral Head
FDA 510(k)
FDA Class 2
·Orthopedic
Philips
FDA UDI
Sbo Hearing A/S·05714464054831·HEARLINK 3030 MNR T R DG
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017989·K-Wire, Single Ended, Trocar Point, Diameter Si...
VEGA KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096
FDA 510(k)
FDA Class 2
·Immunology
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 10, 2014
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011
2.47MM X 30.3MM SPIRAL ROUTER
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013
BD ALARIS¿ PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS S.A. DE C.V.·Product code FPA·March 20, 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