8 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DSL FERRITIN IRMA
FDA 510(k)
FDA Class 2
·Immunology
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813056981·GT NU-IDEAL NATURAL U/019X025 PK/10
TOTAL PROTEIN URINE/CSF GEN.3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ST360 SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·May 30, 2014
FREESTYLE HANDS FREE
FDA Adverse Event
Injury
·MEDELA, INC.·Product code HGX·November 14, 2012
SCREW-IN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·September 23, 2010
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