8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTERIM TEMP. CROWN & BRIDGE RESIN
FDA 510(k)
FDA Class 2
·Dental
MEDOS HILITE 7000 & 7000 LT OXYGENATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
Global Modular Replacement System
FDA 510(k)
FDA Class 2
·Orthopedic
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 27, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 15, 2012
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·September 5, 2010
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH·Product code KNT·June 12, 2024
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015