10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BCR-ABL1 (p210) % IS Kit (Digital PCR Method)
FDA 510(k)
FDA Class 2
·Medical Genetics
Oticon
FDA UDI
Oticon A/S·05714464007202·OTICON MORE 1 MINIRITE R C091
CAPTURE-R READY-SCREEN 3
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·July 31, 2019
Ki Power Tilt System
FDA 510(k)
FDA Class 2
·Physical Medicine
OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP
FDA 510(k)
FDA Class 2
·Neurology
BD PRECISIONGLIDE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·June 25, 2018
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·November 4, 2008
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·July 21, 2011
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 9, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025