9 results
·
35ms
·
Sources: EU EUDAMED, US FDA
COROMETRICS MODEL 150 FETAL MONITOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122826·K-WIRE - DOUBLE TROCAR 0.7mm DIA x 150mm
Acetabular Dome Hole Plug
FDA 510(k)
FDA Class 2
·Orthopedic
AHL GENERIC GLASS IONOMER AESTHETIC RESTORATIVE
FDA 510(k)
FDA Class 2
·Dental
SECONDARY IV SET-SL/CE (50/CS)
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·March 12, 2012
DRILL BIT Ø4.3 L280 F/324.007
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTW·January 17, 2013
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·December 10, 2010
COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·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