10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
120 FR OPTILUME PROSTATE BALLOON DILATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BRUCELLA AGAR W/15% SHEEP BLOOD
FDA 510(k)
FDA Class 1
·Microbiology
SIMUPLAN TREATMENT PLANNING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
UNKENTERPRISE2
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code NJE·June 15, 2023
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·January 17, 2013
NI
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·December 7, 2010
VICTORY XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·July 8, 2014
ENTERPRISE2 4MMX16MM NO TIP
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code NJE·September 22, 2023
ENTERPRISE2 4MMX16MM NO TIP
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code NJE·November 14, 2022
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021