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EXIMO MEDICAL LTD

US

Last updated May 30, 2026

What EXIMO MEDICAL LTD makes

Eximo Medical Ltd manufactures peripheral atherectomy laser systems, including beam guide-catheter devices and laser catheters designed for vascular procedures. Their portfolio includes overdrive (OTW) catheters and laser systems with varying specifications, such as the Auryon Atherectomy Catheter and Auryon Laser System 100-120 Vac, intended for removing atherosclerotic plaque in peripheral arteries.

These devices are classified under Class II in the US regulatory framework and are listed under FDA pathways including 510(k) and UDI registrations. The company is based in the United States, adhering to US medical device compliance requirements.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
US
Address
—
LinkedIn
—
Facebook
—
Phone
(518)795-1676
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
600468941

Catalogue (29)

DeviceModel / ReferenceRegistriesClassStatus
Auryon Atherectomy Catheter EXM-4003-H000
FDA UDI
Class IIActive
2.35 mm OTW B-Laser™ catheter EXM-4004-0000
FDA UDI
Class IIUnknown
Auryon Atherectomy Catheter EXM-4012-0000
FDA UDI
Class IIActive
0.9 mm OTW B-Laser™ catheter EXM-4002-0000
FDA UDI
Class IIUnknown
Auryon Atherectomy Catheter EXM-4010-H000
FDA UDI
Class IIActive
Auryon Laser System 100-120 Vac EXM-2001-1100
FDA UDI
Class IIActive
Auryon Atherectomy Catheter EXM-4004-H000
FDA UDI
Class IIActive
Auryon Atherectomy Catheter EXM-4002-H000
FDA UDI
Class IIActive
Laser system EXM-2001-1100
FDA UDI
Class IIUnknown
Auryon Atherectomy Catheter EXM-4001-H000
FDA UDI
Class IIActive
Laser system EXM-2001-1000
FDA UDI
Class IIUnknown
Auryon Atherectomy Catheter EXM-4012-H000
FDA UDI
Class IIActive
Auryon Atherectomy Catheter 2.0 mm OTW EXM-4003-0000
FDA UDI
Class IIActive
Auryon Atherectomy Catheter EXM-4010-0000
FDA UDI
Class IIActive
Auryon Atherectomy Catheter 2.35 mm OTW EXM-4004-0000
FDA UDI
Class IIActive
Auryon Atherectomy Catheter EXM-4011-0000
FDA UDI
Class IIActive
2.0 mm OTW B-Laser™ catheter EXM-4003-0000
FDA UDI
Class IIUnknown
Auryon Atherectomy Catheter 1.5 mm OTW EXM-4001-0000
FDA UDI
Class IIActive
Auryon Atherectomy Catheter 0.9 mm OTW EXM-4002-0000
FDA UDI
Class IIActive
Auryon Atherectomy Catheter EXM-4011-H000
FDA UDI
Class IIActive
1.5 mm OTW B-Laser™ catheter EXM-4001-0000
FDA UDI
Class IIUnknown
Auryon Atherectomy System K260244
FDA 510(k)
Class IIActive
Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000) K233668
FDA 510(k)
Class IIActive
Auryon Atherectomy Catheters K220116
FDA 510(k)
Class IIActive
Auryon Atherectomy System K202835
FDA 510(k)
Class IIActive
Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating K241553
FDA 510(k)
Class IIActive
Auryon Atherectomy System K221077
FDA 510(k)
Class IIActive
Auryon Atherectomy System K230709
FDA 510(k)
Class IIActive
B-Laser Atherectomy System K181642
FDA 510(k)
Class IIActive

Related Companies

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Authorities

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Eximo Medical Ltd Rehovot Central · IL FEI 3014443747