10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
MAMMOMAT B.brilliant (11372950)
FDA 510(k)
FDA Class 2
·Radiology
TAPER GUIDE
FDA UDI
FOURNITURES HOSPITALIERES INDUSTRIE·03661489536786·
CD HORIZON Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove
FDA 510(k)
FDA Unclassified
·Unknown
VITALITY DR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·November 11, 2008
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·August 10, 2011
INTELLIVUE MULTI MEASUREMENT SERVER X2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·July 17, 2013
Roche Elecsys Folate II for use on Elecsys 210 Analyzers; Catalog No. 3253678 (Roche Material No. 03253678122.
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code CGN·September 15, 2006
ACCOLADE DR SL MRI (Model L311)
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