11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INDIBA COMPACT devices
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113981·HYDRO-DISSECT CANNULA 27GA ANGLED 8MM
PANALIGHT-BLU, MODEL 4175
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set
FDA 510(k)
FDA Class 2
·Anesthesiology
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·November 7, 2008
AED10
FDA Adverse Event
Malfunction
·WELCH ALLYN PROTOCOL, INC.·Product code MKJ·August 31, 2011
SCREW DRIVER SHAFT
FDA Adverse Event
Malfunction
·SEASPINE, INC.·Product code HXX·July 18, 2013
ALINITY I RUBELLA IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFX·November 26, 2025
ALINITY I RUBELLA IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFX·November 7, 2025
ALINITY I RUBELLA IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFX·February 13, 2026
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025