11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Alphenix, INFX-8000F/B, V8.0
FDA 510(k)
FDA Class 2
·Radiology
VENFLON PRO 0.9MM X 25MM
FDA Adverse Event
Injury
·Product code FOZ·May 26, 2021
PROPELLER HEAD SCREW SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304270046·
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704513264·
PRODIGY NPWT SYSTEM MODEL PRODIGY 800V
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIFECARE ARM & LEG PAIN RELIEF SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 10, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011
ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·October 17, 2014
Quanta System Sterile Optical Laser Fiber, reusable
FDA Enforcement
Class II
·Terminated·Quanta System, S.p.A.·June 16, 2021
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