8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PERITONEAL DIALYSIS SYSTEM AND ACCESS.
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BEL BLOOD LEVEL DETECTOR
FDA 510(k)
FDA Class 2
·Cardiovascular
FORA G71A BLOOD GLUCOSE MONITORING SYSTEM, TD-4274 BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BZE·December 22, 2009
ACRYSOF IQ TORIC
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·June 4, 2014
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code FNL·November 2, 2010
MEGASUTURECUT NEEDLE DRIVER
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·January 2, 2013
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020