13 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Arthrex Self-Punching PushLock Suture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
ELMED INCORPORATED
FDA UDI
ELMED INCORPORATED·00198506072819·10 MM DIA., CLASSIC HASSON CANNULA, STAINLESS S...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776208509·Classic Hasson Cannula Trumpet Valve
REX, VERSION 1.0
FDA 510(k)
FDA Class 2
·Radiology
BD PhaSeal Optima Closed System Drug Transfer Device
FDA 510(k)
FDA Class 2
·General Hospital
ANEURX
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·November 3, 2014
URETEX SUP URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·May 15, 2013
SWAN-GANZ HI-SHORE TRUE SIZE THERMODILUTION CATHETER WITH AMC THROMBOSHIELD
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYG·August 23, 2011
INJECTOR LOCKING N40-O
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·September 15, 2021
T-HANDLE MT25 DRIVER
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code HXX·September 30, 2025
BD PHASEAL OPTIMA INJECTOR (N40-O)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·September 14, 2021
INJECTOR LOCKING N40-O
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·September 21, 2021
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
FDA Enforcement
Class II
·Ongoing·Abbott Medical·January 1, 2025