22 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO TSRH SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033559390·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033559444·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033559413·
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K01407N0·Cervical Rasp, 15 x 12, 7mm, 0 Degree, No Taper
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033559406·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033559451·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033559437·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033559420·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0140060·Locking Cap, Temporary, Screw to Screw Distractor
SYNCHRON VANCOMYCIN REAGENT
FDA Adverse Event
BECKMAN COULTER INC.·Product code LEH·June 10, 2011
SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
HEARTSINE SAMARITAN 300P AND PAD-PAK K014067
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·July 19, 2018
HEARTSINE SAMARITAN 300P AND PAD-PAK K014067
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·March 7, 2018
CER BIOLOXD OPTION HD 32MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LZO·September 12, 2014
EVOLUT R TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·February 20, 2023
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013
ACCENT DR RF
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2011
FAST-FIX AB CURVED NEEDLE DELIVERY SYS.
FDA Adverse Event
Malfunction
·SMITH & NEPHEW INC., ENDOSCOPY DIV.·Product code GAS·March 14, 2008