12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AEROVENT PLUS CHC
FDA 510(k)
FDA Class 2
·Anesthesiology
Mayo Scissors
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896119789·Mayo Scissors One Blade Serrated Straight
CRANIAL MOLDING ORTHOSIS
FDA 510(k)
FDA Class 2
·Neurology
INSTAFLO BOWEL CATHETER SYSTEM KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·July 5, 2022
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 13, 2013
FRESENIUS LIBERTY CYCLER
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·September 10, 2014
EPIC II CRITICAL CARE BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 20, 2011
Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes..
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·July 30, 2014
Spectral CT. Computed tomography X-ray system.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 2, 2025