12 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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DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198550·AK3 Ultra Insert Trial Size 2, 18mm
ZMR®
FDA UDI
Zimmer, Inc.·00889024157071·
ZMR®
FDA UDI
Zimmer, Inc.·00889024157088·
ZMR®
FDA UDI
Zimmer, Inc.·00889024157095·
Custom Legacy and Custom InterActive Titanium Abutments
FDA 510(k)
FDA Class 2
·Dental
FLEXICARE BREATHING FILTERS
FDA 510(k)
FDA Class 2
·Anesthesiology
PDS LL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code NEW·March 7, 2013
CONTINU-FLO SOLN. SET, 3 LUERACTIVATED VALVES
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·February 15, 2011
ATTAIN OTW
FDA Adverse Event
Injury
·MPRI·Product code LWP·August 8, 2014
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI 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
PM 1260 ASSURITY + 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