9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ANTI-GBM ANTIBODIES QUANTITATIVE KIT
FDA 510(k)
FDA Class 2
·Immunology
RP UCLA Abutment Waxing Sleeve, Hexed
FDA UDI
STERNGOLD DENTAL LLC·00841549110580·The UCLA-Type Abutment is attached directly to ...
IV SET AN115 23G 1IN BP
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·August 2, 2019
MICRO-VENT ENDOSSEOUS IMPLANT ABUTMENTS
FDA 510(k)
FDA Class 2
·Dental
CATHETER CARE TRAY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SLEEK
FDA Adverse Event
Injury
·CLEARSTREAM TECHNOLOGIES, LTD.·Product code LIT·May 26, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·November 15, 2010
VISI-PRO BALLOON EXPANDABLE BILIARY STENT SYSTEM
FDA Adverse Event
Injury
·EV3 INC.·Product code FGE·January 9, 2013
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