12 results
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18ms
·
Sources: EU EUDAMED, US FDA
DIADOT(TM) VIRUS/CHLAMYDIA TRANSPORT
FDA 510(k)
FDA Class 1
·Microbiology
VITROS
FDA UDI
ORTHO CLINICAL DIAGNOSTICS·10758750000302·VITROS Immunodiagnostic Products FSH Reagent Pack
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515242340·Killian Antrum Cannula, lg, #2 3mm
CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W
FDA 510(k)
FDA Class 2
·Cardiovascular
DEPUY SYNTHES MAXFRAME AUTOSTRUT System
FDA 510(k)
FDA Class 2
·Orthopedic
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·January 28, 2013
TALENT THORACIC STENT GRAFT SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·November 30, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code FRN·February 1, 2014
VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc·Product code CGJ·March 25, 2022
VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922
FDA Recall
Open, Classified
·Ortho Clinical Diagnostics Inc·Product code CGJ·July 12, 2018
VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922
FDA Enforcement
Class II
·Ongoing·Ortho Clinical Diagnostics Inc·October 10, 2018
VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc·May 25, 2022