23 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0140070·T-Handle, T30, Locking Cap Adjuster
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033558744·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033558782·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033558799·
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K01406N0·Cervical Rasp, 15 x 12, 6mm, 0 Degree, No Taper
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033558768·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033558775·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033558751·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033558737·
BD VACUTAINER 9NC 0.5 ML BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·June 1, 2021
UNIVERSAL DENTAL COPING (UDC)
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO TSRH SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ELLUME COVID-19 HOME TEST
FDA Adverse Event
Malfunction
·ELLUME LIMITED·Product code QKP·December 20, 2021
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 16, 2025
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
HI PWR DISPOSBL GRNDING PAD
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code ODR·March 13, 2008