8 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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E.W.L. P-TENS MODEL(TENS
FDA 510(k)
FDA Class 2
·Neurology
Halyard
FDA UDI
O&M HALYARD, INC.·20680651681366·HALYARD,H500,STRWRP,-,36X36,150
NUMED MULLINS PTA CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MAF·May 15, 2014
MAXIMO VR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code LWS·October 31, 2012
SUREFIX
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 25, 2010
Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781359
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021