12 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SubtleHD-CT (1.x)
FDA 510(k)
FDA Class 2
·Radiology
Impact™
FDA UDI
B BRAUN INTERVENTIONAL SYSTEMS, INC·04046964291371·IMPACT 25MMX4CMX120CM
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690199373·Revision Knee Spiral Reamer- Hudson Long Flutes...
Alleset
FDA UDI
GRI Medical & Electronic Technology Co., Ltd.·16931918143699·Bandage, Esmark, Blue, Powderless, 4inx144in_No...
Alleset
FDA UDI
GRI Medical & Electronic Technology Co., Ltd.·16931918184623·Esmark Bandage_4inx144in_Sterile_20ea/cs
ORION
FDA UDI
HNM TOTAL RECON LLC·00841742141213·ORION ø2.5mm Headless Cannulated Screw, Short T...
GSS610N21 Series Steam Sterilizer
FDA 510(k)
FDA Class 2
·General Hospital
GECHO
FDA 510(k)
FDA Class 2
·Radiology
CONTAK RENEWAL 3
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code NIK·November 11, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 19, 2011
GYNECARE TVT OBTURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 30, 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