10 results
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18ms
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Sources: EU EUDAMED, US FDA
URETHRAL AND URETERAL BALLOON DILATATORS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Archon
FDA UDI
Nuvasive, Inc.·00887517080066·Archon Drill Bit, 2.5x10mm Power
Legacy™4 Implant
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307103387·4.7mmD x 11.5mmL, 4.5mmD Platform
FIBRELIGHT ILLUMINATING ORAL RETRACTORS
FDA 510(k)
FDA Class 1
·Dental
MODELS 134, 135 & 136 TRANSFER CART/TABLE
FDA 510(k)
FDA Class 2
·Physical Medicine
ELLIPSE VR, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·June 19, 2014
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·October 25, 2010
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·December 24, 2012
SYNFLATE BALLOON/SMALL- STERILE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code NDN·September 29, 2021
General Pack, Kit numbers: AMS2334, AMS2334(A, AMS2967, AMS2967(A, AMS3239, AMS3709, and AMS3709(A. convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016