8 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODEL TR RECTAL SUCTION BIOPSY TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
A.B. KORKOR MEDICAL SKINNYSAFE INTRODUCER SHEATH
FDA 510(k)
FDA Class 2
·Cardiovascular
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 6, 2014
RETROFLEX 3/ SAPIEN INTRODUCER SHEATH SET
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYB·January 8, 2013
COBAS INTEGRA 800
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·November 18, 2010
CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Millennium Surgical, Medfix International, CareFusion, Boss Instruments, Medline Industries, Surgical Direct, and Teleflex Medical brand names.
FDA Enforcement
Class II
·Terminated·Instrumed International, Inc.·December 17, 2014
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021