11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DEKA SIMON
FDA 510(k)
FDA Class 2
·Physical Medicine
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET
FDA 510(k)
FDA Class 2
·General Hospital
ROCHE ONLINE TDM LIDOCAINE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BD POSIFLUSH¿ SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·December 5, 2022
HYPODERMIC NEEDLE-PRO WITH NEEDLE PROTECTION DEVICE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INC.·Product code FMJ·October 23, 2014
QUANTA SYSTEM S.P.A.
FDA Adverse Event
Malfunction
·QUANTA SYSTEM S.P.A.·Product code GEX·January 4, 2013
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDIC INC, 1818910·Product code KWA·August 18, 2011
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 9, 2026
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 10, 2026
BD VERITOR¿ PLUS ANALYZER
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code PSZ·March 7, 2025
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025