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Domain Surgical, Inc.

US

Last updated May 25, 2026

Information

Country
US
Address
—
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
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EUDAMED SRN
—
FDA FEI Number
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DUNS Number
963249342

Catalogue (23)

DeviceModel / ReferenceRegistriesClassStatus
Fmx G1FP
FDA UDI
Class IIActive
FMwand 2121S
FDA UDI
Class IIActive
FMwand 2301
FDA UDI
Class IIActive
FMsealer 4001
FDA UDI
Class IIActive
FMwand 2102S
FDA UDI
Class IIActive
Fmx G1
FDA UDI
Class IIActive
FMwand 2101
FDA UDI
Class IIActive
FMwand 2301S
FDA UDI
Class IIActive
Fmx RPM
FDA UDI
Class IIActive
FMwand 2302S
FDA UDI
Class IIActive
FMwand 2101S
FDA UDI
Class IIActive
FMwand 2121
FDA UDI
Class IIUnknown
FMwand 2321S
FDA UDI
Class IIActive
FMwand 2102
FDA UDI
Class IIActive
FMwand 2302
FDA UDI
Class IIActive
Fmx DPM
FDA UDI
Class IIActive
FMsealer 3001
FDA UDI
Class IIActive
Fmwand Handpiece Se K140384
FDA 510(k)
Class IIActive
Open Fmsealer K141484
FDA 510(k)
Class IIActive
Domain Surgical System K110439
FDA 510(k)
Class IIActive
Fmwand Ferromagnetic Surgical System K130606
FDA 510(k)
Class IIActive
Laparoscopic FMsealer K142229
FDA 510(k)
Class IIActive
Domain Surgical System K121881
FDA 510(k)
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (1)

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
Oct 24, 2016Z-0690-2017—terminated

Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage.