9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Cervical Plate
FDA 510(k)
FDA Class 2
·Orthopedic
ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325
FDA 510(k)
FDA Class 3
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 1, 2024
GORILLA/BABY GORILLA PLATING SYSTEM
FDA Adverse Event
Injury
·PARAGON 28, INC·Product code HRS·September 17, 2020
INSTINCT ENDOSCOPIC HEMOCLIP
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code MND·June 13, 2013
SCREWDRIVER AXSOS T8 3.0MM LOCKING SET
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS SELZACH·Product code HXX·October 2, 2008
FLORENCE BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL QUEBEC LP·Product code FNL·May 8, 2008
Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017