21 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Elekta Unity
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
DEPUY MITEK, LLC·10886705001927·Super / RC Inserter
NA
FDA UDI
Synthes GmbH·10886982151889·3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE REC...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112830·BARRON VACUUM PUNCH 9.5MM
Origin Size 14 Template
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215074777·
MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40
FDA 510(k)
FDA Class 2
·Anesthesiology
SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ONE TOUCH BASIC ENHANCED
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·October 15, 2002
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
ONE TOUCH ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·October 24, 2008
UV FLASH TRANSFER SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 15, 2011
DEPUY ASR XL FEM IMP SIZE 49
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KXA·July 8, 2013
INJECTOR LUER LOCK N35J
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code ONB·August 13, 2024
PROTECTOR P15J
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code ONB·August 13, 2024
PROTECTOR P15J
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code ONB·August 13, 2024
PROTECTOR P15J
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code ONB·January 20, 2025
EMBLEM MRI S-ICD Model A219
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021