12 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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Difiney Anti Snoring Device
FDA 510(k)
FDA Class 2
·Dental
IdentiTi
FDA UDI
ALPHATEC SPINE, INC.·00190376364896·IdentiTi ALIF SA, T25 Removal Driver, Angled, 4...
IdentiTi
FDA UDI
ALPHATEC SPINE, INC.·00190376372686·IdentiTi ALIF SA, T25 Removal Driver, Angled, 6...
CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE)
FDA 510(k)
FDA Class 2
·Dental
MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 22, 2025
CARPENTIER-EDWARDS PHYSIO MITRAL ANNULOPLASTY RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·November 12, 2008
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 4, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 18, 2013
Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 24, 2020
Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 24, 2020
Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Numbers: 14-400082, 14-400082S, 14-440065S, 14-442000-00, 14-442000S, 14-444000-00, 979105, 14-441045-00, and 14-444000S
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·April 4, 2018