10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Lyka® PORT Needle Free Access Device (4170Y)
FDA 510(k)
FDA Class 2
·General Hospital
"2.4MM" FRACTURE SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036035976·
Portex
FDA UDI
ICU MEDICAL, INC.·15019517083002·
MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENSIZOR ENDOSCOPIC SCISSORS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PUMP MMT-722NAB PRDGM INS V2.2 BL EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·November 21, 2008
CAPIOX AF200X ARTERIAL BLOOD FILTERS
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code FGE·August 17, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 18, 2013
ZEVO CERVICAL PLATE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code HXX·October 7, 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