9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Single-use Flexible Ureteroscope
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813035504·Reamers With Silicone Stops 21MM #40
Oticon
FDA UDI
Sbo Hearing A/S·05714464091799·OTICON JET 1 MINIRITE T C063
AMSINO ENDOTRACHEAL TUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
syngo.CT Dental
FDA 510(k)
FDA Class 2
·Radiology
PFC SIGMA C/R POR FE LF SZ 2.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·December 2, 2008
ZIMMER DERMATOME
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code GFD·September 6, 2011
LEGEND FOOTED ATTACHMENT
FDA Adverse Event
Malfunction
·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·July 29, 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