11 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENHANCE-S PLUS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CAPSTONE CONTROL™ Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169055742·SPACER 3991322 CAPSTONE IR 0 DEG 13X22
CAPSTONE® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994387325·SPACER 2991322 CAPSTONE PEEK 13X22
Capstone Control PTC Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169679481·SPACER 4991322 CONTROL PTC 0 DEG 13X22
E-EEGX, N-EEGX
FDA 510(k)
FDA Class 2
·Neurology
CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NKB·May 15, 2014
EXPEDIUM 5.50 DUAL-INNIE POLYAXIAL SCREW 8.00X100MM, TI
FDA Adverse Event
Injury
·DEPUY SYNTHES SPINE·Product code NKB·March 6, 2013
TRANSVENOUS LEAD
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DTB·August 8, 2014
5MMX 45CM STRYKEPROBE L-TIP
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code GEI·January 25, 2011
Bivona Aire-Cuf Endotracheal Tube
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·November 3, 2021