8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122826·K-WIRE - DOUBLE TROCAR 0.7mm DIA x 150mm
VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE
FDA 510(k)
FDA Class 2
·Microbiology
ZAVATION IBF SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SIGMA SPECTRUM
FDA Adverse Event
SIGMA INTERNATIONAL·Product code FRN·November 22, 2010
VICTORY XL DR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·July 8, 2014
5MM MONOPOLAR HANDLE 33CM
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY·Product code KOG·December 27, 2012
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