11 results
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29ms
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Sources: EU EUDAMED, US FDA
LED Light Therapy Device (Models: SG-FM, SG-FE)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011253086200·ceraMotion® Lf Shoulder transpa, 20 g / dental ...
RX ACCUNET Embolic Protection System
FDA 510(k)
FDA Class 2
·Cardiovascular
MIE - GAMMA CAMERA SYSTEMS
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 10, 2025
LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X260MM X 1
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·August 28, 2012
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·September 26, 2019
ZYPLAST COLLAGEN IMPLANT (1.0ML)
FDA Adverse Event
Injury
·INAMED CORP. (FREMONT)·Product code LMH·December 5, 2008
TOTALCARE BARIATRIC PLUS
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·August 31, 2011
KINETRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 29, 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