9 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sil-Flow
FDA 510(k)
FDA Class 2
·Dental
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813035368·Reamers With Silicone Stops21MM #8
Philips
FDA UDI
Sbo Hearing A/S·05714464093885·HEARLINK 1500 MNR DG
Various Brands of Ultraviolet Lamps
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TELEREHAD 2004
FDA 510(k)
FDA Class 2
·Cardiovascular
ARTICUL/EZE BALL 28+1.5 GR
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD·Product code JDI·December 2, 2008
*
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL INC.·Product code FRN·May 30, 2013
ECHELON FLEX
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GDW·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