9 results
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18ms
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Sources: EU EUDAMED, US FDA
AYON Body Contouring System (AYON SYSTEM)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
T:SLIM X2 INSULIN PUMP
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·February 10, 2021
DEKA SMARTPERIO
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Aesculap OrthoPilot Next Generation
FDA 510(k)
FDA Class 2
·Neurology
LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X260MM X 1
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·August 28, 2012
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FPO·August 3, 2011
DUROM US ACETABULAR COMPONENT 58/52 R
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWB·December 2, 2008
MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·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