9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ASTEION CT SCANNER, TSX-021A
FDA 510(k)
FDA Class 2
·Radiology
5982787
FDA Adverse Event
Malfunction
·September 28, 2016
DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 200-2019
FDA 510(k)
FDA Class 1
·Hematology
VITAL SIGNS MONITOR, MODEL: MD500B
FDA 510(k)
FDA Class 2
·Cardiovascular
RED DBI-DC3
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·June 13, 2014
PGW .018 SV SHORT
FDA Adverse Event
Malfunction
·CORDIS CORPORATION·Product code DQX·February 28, 2013
TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX
FDA Adverse Event
Malfunction
·CORDIS NEUROVASCULAR, INC.·Product code HCG·February 9, 2011
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 11, 2024
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025