9 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RT Carbon ECG Leads
FDA 510(k)
FDA Class 2
·Cardiovascular
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776181833·BRUNS CURETTE ANG OVAL SIZE
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780187219·Integra® Jarit® Bruns Oval Cup Curette, 8", Ang...
F3D Cervical Stand-Alone Interbody Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
RABBIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TENDRIL STS
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·September 9, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 10, 2014
PELVISOFT ACELLULAR COLLAGEN BIOMESH
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTL·July 18, 2013
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013