9 results
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35ms
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Sources: EU EUDAMED, US FDA
EPI DENT TOOTHBRUSH
FDA 510(k)
FDA Class 1
·Dental
AXL CANNULATED CROSSPIN TRAY
FDA UDI
Biomet Orthopedics, LLC·00880304485150·
LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER
FDA 510(k)
FDA Class 1
·Clinical Toxicology
TRI-FIX SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·June 27, 2014
UNKNOWN DEPUY CORAIL STEM
FDA Adverse Event
Injury
·DEPUY FRANCE S.A.S.-SAINT PRIEST·Product code JDI·January 8, 2013
PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 16, 2010
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·April 19, 2024
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013