8 results
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22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEWPORT ELECTRONIC MANOMETER
FDA 510(k)
FDA Class 2
·Anesthesiology
SYLVAN PEDIASCAN 200 TRANSILLUMINATOR
FDA 510(k)
FDA Class 1
·Ophthalmic
IMASK TM
FDA 510(k)
FDA Class 2
·Anesthesiology
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·April 11, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 16, 2010
Z-LOOK3
FDA Adverse Event
Injury
·Z-SYSTEMS AG·Product code DZE·February 4, 2013
ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026