8 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 11, 2021
BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·October 1, 2014
PRISMA M60 PRE SET
FDA Adverse Event
GAMBRO INDUSTRIES·Product code KDI·April 9, 2006
DIAMOND 3
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·June 16, 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