9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TOP HYPODERMIC SYRINGE LUER LOCK
FDA 510(k)
FDA Class 2
·General Hospital
Air Bubble Based Infuser (ABBI)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CENTRICITY PACS SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 14, 2014
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 15, 2012
HOMECHOICE AUTOMATED PD SET W/CASS.-4 PRONG, EUR.
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·September 24, 2010
Knee Scope Pack, part number AMS2498(A Knee Scope Pack, part number AMS2498(B Knee Scope Pack, part number AMS2498(C
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
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
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015