9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
ArgenPMMA Multi98x30-D4
FDA UDI
ARGEN CORPORATION, THE·D818123298·Crown And Bridge, Temporary, Resin
HEMCON BANDAGE
FDA 510(k)
FDA Unclassified
·Unknown
ACAM 5 AUDIOMETER SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
HEMOCONCENTRATOR BC 20 PLUS
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code KDI·April 1, 2016
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 21, 2013
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·September 26, 2014
PIN COLLET
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code GET·June 8, 2011
Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026