11 results
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20ms
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Sources: EU EUDAMED, US FDA
YSIO X.pree
FDA 510(k)
FDA Class 2
·Radiology
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813033302·CBCT Pano Cape Apron with Collar
Philips
FDA UDI
Sbo Hearing A/S·05714464089789·HEARLINK 1700 MNR DG
Stainless Steel Archwire
FDA UDI
Ortho Arch Company Inc·D9092507381·.016 X .016 SS UTILITY ARCHES 38MM (5)
FT FIBER OPTIC DELIVERY SYSTEMS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VitreaView
FDA 510(k)
FDA Class 2
·Radiology
MSS - HUMERAL REVERSE LINERS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·February 18, 2026
SUPER TURBO VAC 90
FDA Adverse Event
Malfunction
·ARTHROCARE CORP.·Product code GEI·June 19, 2013
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·September 12, 2011
8010042-2008-00150
FDA Adverse Event
Malfunction
·Product code CBK·September 23, 2008
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