17 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RFA-1717DIG, RFA-1717DIC
FDA 510(k)
FDA Class 2
·Radiology
Votion®
FDA UDI
Ortho Organizers, Inc.·00190707113308·Votion .018 MC(0T) U/L 5x5 Hks 345 SPK VOTION
Votion
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730007599·Votion 018 MC(0T) U/L 5x5 Hks 345 SPK
NXSTAGE SYSTEM ONE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
MCKESSON CONSULT 120 URINE ANALYZER
FDA Adverse Event
Malfunction
·ACON LABORATORIES, INC.·Product code KQO·January 21, 2025
ALLEGIANCE DISPOSABLE VAGINAL SPECULUM
FDA Adverse Event
Malfunction
·ALLEGIANCE/CARDINAL HEALTH·Product code HIB·October 24, 2008
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 8, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 8, 2013
SYRINGE 10ML LL-
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·June 27, 2024
BD NANO¿ 2ND GEN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·November 22, 2022
BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·October 25, 2023
CEFALY
FDA Adverse Event
Injury
·CEFALY TECHNOLOGY·Product code PCC·March 9, 2026
CEFALY
FDA Adverse Event
Injury
·CEFALY TECHNOLOGY·Product code PCC·March 9, 2026
BD NANO¿ 2ND GEN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 14, 2022
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025