9 results
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19ms
·
Sources: EU EUDAMED, US FDA
Lithoblast Single Use Holmium Laser Fibers
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813034248·Hedstrom Files with Silicone Stops 31mm 15-40
Philips
FDA UDI
Sbo Hearing A/S·05714464093861·HEARLINK 1500 MNR BR/TP
AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
Medrobotics Flex System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
PINN MAR NEUT 28IDX50OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·December 2, 2008
VIASYS
FDA Adverse Event
Malfunction
·CAREFUSION 207, INC DBA CAREFUSION·Product code LSZ·May 2, 2013
CASE P2 SERIES
FDA Adverse Event
Malfunction
·GE HEALTHCARE·Product code DQK·September 13, 2011
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