8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2)
FDA 510(k)
FDA Class 2
·Neurology
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00843471150757·Ten-Ties, Baby Blue
NuVasive® TLX Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO: V.A.C. GRANUFOAM SILVER PROTECTION DRESSING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VENTAK PRIZM HE DR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·November 11, 2008
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·August 10, 2011
BARD-PARKER
FDA Adverse Event
Malfunction
·Product code GES·July 16, 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