8 results
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19ms
·
Sources: EU EUDAMED, US FDA
GASTRIN 34 HORMONE BY RADIOUMMUNOASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
STALIF CTI, STALIF C
FDA 510(k)
FDA Class 2
·Orthopedic
OSS/(SCARF)- AND OSW-SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
HEARTWARE® VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Malfunction
·HEARTWARE, INC·Product code DSQ·May 31, 2014
COPILOT BLEEDBACK CONTROL VALVE
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code DTL·November 21, 2012
REPAIR CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·August 26, 2010
Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Azurion 7 B20, Model Number 722068. 5. Azurion 7 M12, Model Number 722078. 6. Azurion 7 M20, Model Number 722079. 7. Azurion 3 M12, Model Number 722221. 8. Azurion 3 M15, Model Number 722222. 9. Azurion 7 M12, Model Number 722223. 10. Azurion 7 M20, Model Number 722224. 11. Azurion 7 B12, Model Number 722225. 12. Azurion 7 B20, Model Number 722226. 13. Azurion 5 M12, Model Number 722227. 14. Azurion 5 M20, Model Number 722228. 15. Azurion 7 M20, Model Number 722282.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP 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