7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ISOSCREEN-CK CONFIRMATORY KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BARD GASTROSTOMY FEEDING DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INTRASITE* GEL (3) YEAR SHELF LIFE
FDA 510(k)
FDA Unclassified
·Unknown
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 26, 2014
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·January 3, 2013
ATLAS PLUS HF CRT-D
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·November 10, 2010
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020