21 results · 31ms · Sources: EU EUDAMED, 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