9 results
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28ms
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Sources: EU EUDAMED, US FDA
CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)
FDA 510(k)
FDA Class 2
·Physical Medicine
UltraDrape UGPIV Barrier and Securement (34-15)
FDA 510(k)
FDA Class 2
·Radiology
BeautiBond Xtreme
FDA 510(k)
FDA Class 2
·Dental
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·September 14, 2011
BIPOLAR POROUS
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code DTB·November 11, 2008
J-VAC RESERVOIRS
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code KOG·July 30, 2013
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
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