10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPIRIT RIDGE SILICONE CARVING BLOCK
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SeaSpine Shoreline ACS - Anterior Cervical Standalone System
FDA 510(k)
FDA Class 2
·Orthopedic
SINGLE NEEDLE HEMODIALYSIS (BFC-161)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·May 26, 2014
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·January 16, 2013
STRATA NCS LP SHUNT KIT, CLOSED TIP
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·January 12, 2011
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
DAILIES COLORS
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code LPL·January 30, 2026