9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TROJAN-ENZ LATEX CONDOMS W/SPERMICIDAL MODIFIED
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TROJAN NIRVANA COLLECTION LUBRICATED CONDOMS
FDA Adverse Event
Injury
·CHURCH & DWIGHT CO., INC.·Product code HIS·June 24, 2020
GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER,
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Jada System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·June 30, 2014
TRUFECTA VALVE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC. (CS-WOODRIDGE)·Product code LWQ·January 4, 2013
*
FDA Adverse Event
Malfunction
·MEDTRONIC NEURO·Product code LKK·November 9, 2010
ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE
FDA Adverse Event
Injury
·COOK INC·Product code DQX·January 26, 2018
Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021