10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
40-HZ AUDITORY EVOKED RESPONSE TEST
FDA 510(k)
FDA Class 2
·Neurology
INNOVACON HCG UKTRA TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Soft Plug Extended Duration 180 Canalicular Plug
FDA 510(k)
FDA Unclassified
·Unknown
CONSULT HCG TEST
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHI·March 4, 2025
CORAIL2 STD SIZE 16
FDA Adverse Event
Injury
·DEPUY FRANCE SAS - 3003895575·Product code KWA·January 3, 2019
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code NVY·June 10, 2014
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·December 10, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·June 23, 2015
CONSULT HCG URINE CASSETTE 5001 25T
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHI·September 9, 2019
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020