11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Sklar®
FDA UDI
SKLAR CORPORATION·10649111307096·SKLIT XD MAYO HEGAR NH SERR 7"
LORENZ 2.4 SELF DRILLING SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
UGEO PT60A DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
SERVO-S
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·August 1, 2019
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code JDI·September 2, 2011
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 14, 2008
PELVICOL 4 X 12 CM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE·Product code FTL·July 8, 2013
MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
FDA Enforcement
Class III
·Terminated·Invivo Corporation·October 28, 2020
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025