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Torax Medical, Inc.

United States·US-MF-000016782

Last updated September 17, 2026

Information

Country
United States
Address
4545, Creek Road, Cincinnati, United States
Website
its.jnj.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
+1(877)384-4266
PRRC Contact
Emma Cinibulk
EUDAMED SRN
US-MF-000016782
FDA FEI Number
3008766073
DUNS Number
137949538

Catalogue (34)

DeviceModel / ReferenceRegistriesClassStatus
Linx LXMC16
FDA UDI
Class IIIActive
ETHICON Linx Esophagus Sizing Tool LST
FDA UDI
Class IIActive
Linx LSSUS
FDA UDI
Class IIIActive
Linx LS-[12]
FDA UDI
Class IIIUnknown
Fenix FXS-[16]
FDA UDI
UnclassifiedUnknown
Linx LXC-[15]
FDA UDI
Class IIIUnknown
Linx LXMC13
FDA UDI
Class IIIActive
Linx LS-[13]
FDA UDI
Class IIIUnknown
Linx LXMC14
FDA UDI
Class IIIActive
Fenix FIT-2
FDA UDI
UnclassifiedUnknown
Linx LXMC17
FDA UDI
Class IIIActive
Linx LS-[17]
FDA UDI
Class IIIUnknown
Linx LXC-[14]
FDA UDI
Class IIIUnknown
Fenix FXTS
FDA UDI
UnclassifiedUnknown
Fenix FXS-[19]
FDA UDI
UnclassifiedUnknown
LINX Reflux Management System LXMC12
FDA UDI
Class IIIActive
Linx LXC-[17]
FDA UDI
Class IIIUnknown
Linx LXC-[16]
FDA UDI
Class IIIUnknown
Linx LXC-[13]
FDA UDI
Class IIIUnknown
Fenix FXS-[15]
FDA UDI
UnclassifiedUnknown
Linx LXC-[12]
FDA UDI
Class IIIUnknown
Linx LXMC15
FDA UDI
Class IIIActive
Linx LS-[14]
FDA UDI
Class IIIUnknown
Linx LS-[15]
FDA UDI
Class IIIUnknown
Fenix FXBS
FDA UDI
UnclassifiedUnknown
Fenix FXS-[20]
FDA UDI
UnclassifiedUnknown
Linx LS-[16]
FDA UDI
Class IIIUnknown
Fenix FXS-[17]
FDA UDI
UnclassifiedUnknown
Fenix FXS-[14]
FDA UDI
UnclassifiedUnknown
Fenix FXS-[18]
FDA UDI
UnclassifiedUnknown
ETHICON LINX® Esophagus Sizing Tool K230089
FDA 510(k)
Class IIActive
ETHICON Linx Esophagus Sizing Tool K201035
FDA 510(k)
Class IIActive
LINX Reflux Mnagement System P100049
FDA PMA
Class IIIActive
Linx LXM15
EUDAMED
Class IIbActive

Related Companies

Authorised Representatives

Importers

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Notified Bodies

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Authorities

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FDA Recalls (5)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Apr 20, 2018Z-2038-2018—terminated

Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.

Apr 20, 2018Z-2040-2018—terminated

Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.

Apr 20, 2018Z-2039-2018—terminated

Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.

Apr 20, 2018Z-2037-2018—terminated

Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.

Apr 20, 2018Z-2041-2018—terminated

Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.