9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MSFX Mikron Cervical Anterior Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
Procare Basic Upper Arm BP Monitor
FDA UDI
ARISE MEDICAL LLC·00372217004035·Upparm Arm blood pressure monitor with standard...
Oticon
FDA UDI
Sbo Hearing A/S·05714464058211·OTICON ZIRCON 1 MINIRITE T C063
MAXO2+, MODEL A AND AE
FDA 510(k)
FDA Class 2
·Anesthesiology
CARTO® 3 EP Navigation System with Signal Processing Unit
FDA 510(k)
FDA Class 2
·Cardiovascular
TENDRIL DX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011
HT50 VENTILATOR
FDA Adverse Event
Malfunction
·FLIGHT MEDICAL LTD.·Product code CBK·August 29, 2008
2.5MM COARSE DIAMOND BALL, STD
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 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