8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ExcelsiusGPS® Instruments
FDA 510(k)
FDA Class 2
·Neurology
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
FDA 510(k)
FDA Class 2
·Orthopedic
Propeller Model 2014-D Sensor
FDA 510(k)
FDA Class 2
·Anesthesiology
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 9, 2023
FIXED DURAGUARD, 16MM
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·July 28, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code IOR·November 11, 2014
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025