9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668110973·STERILIZING CASE MEDIUM/SMALL
QLAB QUANTIFICATION SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
RESPONDER Polysaccharide Hemostat
FDA 510(k)
FDA Unclassified
·Unknown
ENTERPRISE2 4MMX39MM NO TIP
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code NJE·July 18, 2022
BIVONA CUSTOM TRACHEOSTOMY TUBE
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD, INC.,·Product code JOH·December 6, 2010
ZEPHYR DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·July 8, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·December 7, 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