11 results
·
21ms
·
Sources: EU EUDAMED, US FDA
LIFESTYLES ZERO LUBRICATED LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·October 14, 2021
BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·September 15, 2021
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·August 27, 2020
APC PLUS ADHESIVE
FDA 510(k)
FDA Class 2
·Dental
MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A
FDA 510(k)
FDA Class 2
·Cardiovascular
APC PLUS, CLARITY, MINI UNI-TWIN, VICTORY SERIES
FDA Adverse Event
Injury
·3M UNITEK·Product code DYH·May 9, 2012
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·May 20, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·June 10, 2011
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015