16 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ava Fertility Tracker
FDA 510(k)
FDA Unclassified
·Unknown
DEBAKEY NEEDLE PULL FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896060319·DEBAKEY NEEDLE-PULLING FORCEPS TUNGSTEN CARBIDE...
TO BE ASSIGNED
FDA UDI
FGX INTERNATIONAL INC.·00193033540008·
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113974·HYDRO-DISSECT CANNULA 25GA ANGLED 8MM
24M - Nevada Energy - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588011639·24M - Nevada Energy - Metal
TMC PSI Cut Guide System
FDA UDI
Treace Medical Concepts, Inc.·00810111222723·Cut Guide
PM 2002 PROLINE/AEC
FDA 510(k)
FDA Class 2
·Dental
NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 28, 2025
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON SARL A JOHNSON & JOHNSON CO·Product code FTL·August 6, 2004
TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·August 27, 2019
TRUERESULT
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·October 21, 2014
SPEEDICATH CH14 MALE
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code GBM·August 10, 2011
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·July 1, 2013
SEE H.10
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·August 18, 2023
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021