11 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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URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Malibu
FDA UDI
Seaspine Orthopedics Corporation·10889981080648·Seat Adjuster
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111017·SILICONE MAT FOR INSTRUMENT CADDY
DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET
FDA 510(k)
FDA Class 2
·Hematology
VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·July 14, 2015
ANEURX ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·January 11, 2013
ACCU-CHEK ® COMPACT PLUS TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 3, 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
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023