9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
BIO-DETEK EEG ELECTRODE
FDA 510(k)
FDA Class 2
·Neurology
SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE
FDA 510(k)
FDA Class 2
·Orthopedic
STRYKER QUIKFLAP STERILE PROCEDURE PACK
FDA 510(k)
FDA Class 2
·Neurology
COULTER® ACT DIFF 2 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC·Product code GKZ·December 7, 2010
UMBILICAL CATHETER
FDA Adverse Event
Malfunction
·VYGON·Product code FOS·February 17, 2021
PROPLEGE CORONARY SINUS CATHETER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DWF·January 17, 2013
INFUSOR TWO DAY 2ML/HR 12 PK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·December 10, 2010
LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·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