13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ethos Treatment Management, Ethos Treatment Planning
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113264·SIDEPORT KNIFE 1MM ANGLED (BX/5)
WRISTORE FIXATOR
FDA 510(k)
FDA Class 2
·Orthopedic
PRESSURIZED INFUSION PUMP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 6, 2025
IOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 15, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 30, 2014
ARTICULEZE M HEAD 36MM -2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·July 9, 2013
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023