15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228
FDA 510(k)
FDA Class 2
·General Hospital
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112663·BARRON CORNEAL PUNCH 8.75MM
Aveta Drape Pump
FDA UDI
MEDITRINA, INC.·00850006759811·Aveta Drape Pump
IQ FLEX M
FDA Adverse Event
Malfunction
·FIRST SOURCE INC.·Product code IZL·May 29, 2024
NUVASIVE LONG LATERAL SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SYRINGE 50ML LL CONVENIENCE TRAY EUROPE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·January 24, 2024
CARPENTIER-EDWARDS PHYSIO MITRAL ANNULOPLASTY RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·October 23, 2008
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC.·Product code NBW·July 8, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 8, 2013
BD SYRINGE 50ML LL CONVENIENCE TRAY
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·January 10, 2024
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
SYRINGE 50ML LL CONVENIENCE TRAY EUROPE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·April 15, 2024
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