10 results
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18ms
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Sources: EU EUDAMED, US FDA
GAMBRO ALWALL GFE 11 & 15 HOLLOW FIBER DIALYZERS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Syntec Femoral Nail System
FDA UDI
SYNTEC SCIENTIFIC CORPORATION·04712782906765·Syntec Recon Screw φ6.3 x L80mm
Syntec Recon Screw
FDA UDI
SYNTEC SCIENTIFIC CORPORATION·04712782907038·Syntec Recon Screw φ6.3 x L80mm
INTREPID SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Silicone Personal Lubricant, ALL-IN-ONE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·May 6, 2014
COLLEAGUE 3 CXE VOLUMETRICINFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 22, 2010
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·December 19, 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