9 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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All-in-One Health Monitor, PC-303
FDA 510(k)
FDA Class 2
·Cardiovascular
RIVA STAR SILVER DIAMINE FLUORIDE
FDA Adverse Event
Injury
·SDI LIMITED·Product code LBH·February 13, 2019
SUREFIT DUAL DISPERSIVE ELECTRODE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NUNC IVF DISHES AND NUNC IVF 4-WELL DISH
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 16, 2024
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 14, 2014
VA LOCKSCR Ø2.4 SELF-TAP L20 TAN
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HRS·June 14, 2013
TROCHANTERIC NAIL KIT, TI 11X180MM X 130
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 13, 2011
MAGNETOM Skyra fit. Model Number: 10849580.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025