8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FORZA XP Expandable Spacer System
FDA 510(k)
FDA Class 2
·Orthopedic
CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)
FDA 510(k)
FDA Class 2
·Orthopedic
ENDOTAK RELIANCE G
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·November 11, 2008
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
FDA Adverse Event
Injury
·HOLOGIC·Product code HIH·September 14, 2011
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 30, 2013
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