7 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
REPROCESSED COLD BIOPSY FORCEPS
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
SPINEDESIGN Spine Surgery Planning (Software Application)
FDA 510(k)
FDA Class 2
·Radiology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·February 4, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·December 30, 2010
TAPER SLEEVE ADAPTER 12/14 +2
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·July 17, 2014
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015