8 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Disposable Trocars
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
K-TECH 2 POWER TILT SEATING SYSTEM, MODEL K2PT
FDA 510(k)
FDA Class 2
·Physical Medicine
PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY)
FDA 510(k)
FDA Class 2
·General Hospital
CONSENSUS PS KNEE SYSTEM
FDA Adverse Event
Malfunction
·CONSENSUS ORTHOPEDICS INC.·Product code JWH·July 30, 2014
CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code LWR·November 13, 2008
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·September 2, 2011
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 18, 2013
Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.
FDA Enforcement
Class II
·Terminated·Alcon Research Laboratories Ltd.·March 6, 2019