10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CD Horizon Spinal System Instruments
FDA 510(k)
FDA Class 2
·Neurology
GMK-SPHERE 02.12.0310FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 6, 2023
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 14, 2023
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 2, 2025
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·November 11, 2014
CONTOUR CURVED CUTTER STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 12, 2011
ENDOTAK ENDURANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 23, 2013
Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025