12 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Parcus ATLAS
FDA 510(k)
FDA Class 2
·Orthopedic
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017897·K-Wire, Double Ended, Trocar Point, Diameter Si...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017903·K-Wire, Double Ended, Trocar Point, Diameter 0....
ORTHOPILOT NEXT GENERATION-UKA SOFTWARE, MODEL FS210
FDA 510(k)
FDA Class 2
·Neurology
DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604
FDA 510(k)
FDA Class 2
·Immunology
GORILLA/BABY GORILLA PLATING SYSTEM
FDA Adverse Event
Injury
·PARAGON 28, INC·Product code HRS·September 17, 2020
BRONCHO CATH RIGHT
FDA Adverse Event
Injury
·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code CBI·October 3, 2008
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·July 25, 2011
OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FJI·June 21, 2013
VENT RES TR SAL-RIC ST BA
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES MANSFIELD·Product code JXG·November 17, 2021
VENT RES TR SAL-RIC ST BA
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES MANSFIELD·Product code JXG·November 17, 2021
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024