17 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device
FDA 510(k)
FDA Class 2
·Orthopedic
OCTARAY Mapping Catheter
FDA UDI
Biosense Webster Inc·10846835021134·OCTA,GALAXY,3-3-3-3-3,F-CURVE
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321609060·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311609060·
CALYPSO 4D LOCALIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
APEX SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 5, 2022
FARAPULSE PFA SYSTEM AND FARAWAVE PULSED FIELD ABLATION (PFA) SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code QZI·June 13, 2025
FARADRIVE SHEATH
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DRA·July 18, 2025
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
CONCERTO
FDA Adverse Event
Malfunction
·WAVELIGHT GMBH·Product code LZS·June 16, 2011
EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code FGE·June 6, 2008
OCTA,LNG,48P,3-3-3-3-3,F-CURVE
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code MTD·January 10, 2024
VARIPULSE¿ BI-DIRECTIONAL CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code QZI·February 5, 2026
QDOT MICRO
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code OAE·November 13, 2025
NSK
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code EGS·September 29, 2016
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018