9 results
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19ms
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Sources: EU EUDAMED, US FDA
Relu Cloud
FDA 510(k)
FDA Class 2
·Radiology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694018470·MFx 2.7mm x 8mm Angulated Locking Safety Screw
PYLO-PLUS
FDA 510(k)
FDA Class 1
·Microbiology
Surgical Face Masks
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code KRH·December 2, 2008
PINNACLE 100 ACET CUP 52MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·September 19, 2011
PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INTL. LTD.·Product code BTR·July 15, 2013
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 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