12 results
·
27ms
·
Sources: EU EUDAMED, US FDA
RATEMINDER III INFUSION DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
HYDRO-THERM HME WITH LUER PORT
FDA UDI
Intersurgical Incorporated·05030267055692·HYDRO-THERM HME WITH LUER PORT
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668111277·TYING FORCEPS STRAIGHT TITANIUM
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690127000·Modular Tibia IM Tower
LISTER BANDAGE SCISSORS 6-0063(3,5 - 500 PCS
FDA 510(k)THROMBINEX BOVINE THROMBIN
FDA 510(k)
FDA Class 2
·Hematology
Widex
FDA UDI
Widex A/S·05706069665819·COMPASS GPS V2.4, USB plug
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 9, 2014
CONCERTO II CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 5, 2010
UNKNOWN OPTEASE VENA CAVA FILTER
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code DTK·December 3, 2012
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