8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209132317·
WILCOR-XR RP-OG MEDICAL FILM
FDA 510(k)
FDA Class 1
·Radiology
ACUTE HEMODIALYSIS TRAYS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PROMOTE PLUS CRT-D
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·June 6, 2014
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 3, 2012
GEMSTR 7 THPY ALT ST
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·September 9, 2010
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013