9 results
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20ms
·
Sources: EU EUDAMED, US FDA
HEMATASTAT C-70B
FDA 510(k)
FDA Class 2
·Hematology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450412510·
LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X400MM X 1
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·November 13, 2012
N LATEX LP(A)
FDA 510(k)
FDA Class 2
·Immunology
MICROAIRE SURGICAL INSTRUMENTS LLC
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VITALITY
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 14, 2013
COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·December 2, 2010
VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code CEW·July 3, 2014
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017