9 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LUSTER, DENTAL POLISHING PASTE
FDA 510(k)
FDA Class 1
·Dental
LEONE SPA
FDA UDI
LEONE SPA·08033707058298·DB TUBE MIM CONV 22/45 T-10 R+8 UL
LEONE SPA
FDA UDI
LEONE SPA·08033707064725·TUBE MIM CONV 22/45 T-10 R+8 UL
Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System
FDA 510(k)
FDA Class 2
·Orthopedic
MIRAGE SWIFT
FDA 510(k)
FDA Class 2
·Anesthesiology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 2, 2014
3.5MM 90-S SERFAS ENERGY SUCTION PROBE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY PUERTO RICO·Product code GEI·October 22, 2012
HUDSON NEONATAL DUAL HEATED LIMB CIRCUIT
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CAI·August 31, 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