16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MAT PLATFORM,***CUSTOM***,UPH,4X6
FDA UDI
Hausmann Enterprises, LLC·00840314804167·
MAT PLATFORM,4X6,OAK,Black
FDA UDI
Hausmann Enterprises, LLC·00840314804211·
SPIRALE DRUG DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
MEDYSSY LT CAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MAT PLATFORM,4X6,NAT,GRAY
FDA UDI
Hausmann Enterprises, LLC·00840314804181·
MAT PLATFORM,4X6,NAT,BLUE
FDA UDI
Hausmann Enterprises, LLC·00840314804174·
MAT PLATFORM,4X6,FOLK,BLUE
FDA UDI
Hausmann Enterprises, LLC·00840314804198·
MAT PLATFORM,4X6,FOLK,GRAY
FDA UDI
Hausmann Enterprises, LLC·00840314804204·
MALLINCKRODT
FDA Adverse Event
Malfunction
·COVIDIEN·Product code BTR·August 17, 2016
INCORPORATE
FDA UDI
SPINAL ELEMENTS·00840606151603·14 X 12 CERVICAL TRIALS 46MM 0° LORDOSIS
INCORPORATE
FDA UDI
SPINAL ELEMENTS·00840606151795·14 X 12 CERVICAL TRIALS 46MM 10° LORDOSIS
ACCESS ACCUTNL+3 REAGENT
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code MMI·October 3, 2014
IMPLANT INSERTION SLEEVE Ø14 L274 F/PERC
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code MQN·June 3, 2013
UNKNOWN DEPUY SZ4 C/R FEMORAL
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·June 22, 2011
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018