11 results
·
25ms
·
Sources: EU EUDAMED, US FDA
QUINEVAC II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·March 16, 2021
FDR GO FLEX
FDA 510(k)
FDA Class 2
·Radiology
SIMPLICITY SIMPLEX SOFT INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 130
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 17, 2012
ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·February 19, 2016
ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 1, 2016
COAGUCHEK® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·December 13, 2010
FUSION NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·January 17, 2013
CONFIRM
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code MXC·July 8, 2014
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