11 results
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18ms
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Sources: EU EUDAMED, US FDA
EFFERVESCENT DENTURE CLEANSER
FDA 510(k)
FDA Class 1
·Dental
Syntec Femoral Nail System
FDA UDI
SYNTEC SCIENTIFIC CORPORATION·04712782906659·Syntec Internal Hex Captured Screw φ5.0x L65mm
Universal Holder assy
FDA UDI
Maquet Critical Care AB·07325710004289·
Syntec Internal Hex Captured Screw
FDA UDI
SYNTEC SCIENTIFIC CORPORATION·04712782906925·Syntec Internal Hex Captured Screw φ5.0 x L65mm
BEAUTIFIL OPAQUER
FDA 510(k)
FDA Class 2
·Dental
ORISE Gel
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·May 6, 2014
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·October 22, 2010
PROPLEGE CORONARY SINUS CATHETER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DWF·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