11 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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Ortho System
FDA 510(k)
FDA Class 2
·Dental
Sonic
FDA UDI
Sonic Innovations, Inc.·05711583028781·CR60 IICW, WL BL CHEER 60
MODIFICATION TO:CONTOUR SE MICROSPHERES
FDA 510(k)
FDA Class 2
·Neurology
XENON(TM) PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 3, 2025
TOTAL ASR FEM IMP SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·October 14, 2014
ZERO-P CONVEX H5 PEEK
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code OVE·June 15, 2013
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·July 21, 2011
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
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·October 27, 2021
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026