10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RIFAMPIN DISC
FDA 510(k)
FDA Class 1
·Microbiology
MONDEAL
FDA UDI
MONDEAL Medical Systems GmbH·04050435064180·MCD Screw 4.0 x 14 mm M3
non lo...
Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
BLUEWAND LED DENTAL CURING WAND SYSTEM
FDA 510(k)
FDA Class 2
·Dental
BD SAFETYGLIDE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·October 17, 2023
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 30, 2014
SOL SYS 8/15.0 SML ST
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code LPH·November 20, 2012
ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·September 17, 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
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015