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Carbon Medical Technologies, Inc.

United States·US-MF-000044355

Last updated September 17, 2026

About

Today, Carbon Medical Technologies (CMT) is one of only five organizations worldwide with a dedicated pyrolytic carbon coating facility, allowing us to engineer and manufacture devices that are durable, dependable, and trusted by clinicians. Over the past three decades, we’ve built a portfolio of clinically proven products that support patients, simplify procedures, and raise the standard of care across multiple specialties.

From the manufacturer's own website. Source

What Carbon Medical Technologies, Inc. makes

Carbon Medical Technologies, Inc. manufactures implantable radiological image markers, submucosal injection needles, synthetic polymer urinary tract reconstructive materials, non-medicated single-use general surgical procedure kits, single-use general-purpose endoscopic needles, and single-use needle guides.

The company's devices are classified as Class II, Class III, and Class IIb and are listed in Eudamed, FDA 510(k), FDA PMA, and FDA UDI databases. Carbon Medical Technologies, Inc. is based in the United States.

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

Frequently asked questions

What types of devices does Carbon Medical Technologies, Inc. manufacture?

Where is Carbon Medical Technologies, Inc. based?

Carbon Medical Technologies, Inc. is based in the United States, as indicated by the COUNTRY field in the device data, which specifies US as the company's location.

In which regulatory registries are Carbon Medical Technologies, Inc.'s devices listed?

The company's devices are listed in Eudamed, FDA 510(k), FDA PMA, and FDA UDI databases, as directly stated in the LISTED IN field and confirmed in the SUMMARY section of the provided data.

How are Carbon Medical Technologies, Inc.'s devices classified?

The devices manufactured by Carbon Medical Technologies, Inc. are classified as Class II, Class III, and Class IIb, as explicitly listed in the DEVICE CLASSES field and reiterated in the SUMMARY, reflecting the regulatory risk-based categorization applicable to their products.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 1290, HAMMOND ROAD, SAINT PAUL, United States
Website: WWW.CARBONMED.COM
LinkedIn: linkedin.com/company/carbon-med-technologies-inc/mycompany
Facebook: facebook.com/Carbon-Medical-Technologies-Inc-109530911330572
Email: [email protected]
Phone: 1 651 653 8512
PRRC Contact: ERIC FURLICH
EUDAMED SRN: US-MF-000044355
FDA FEI Number: 3002619738
DUNS Number: —

Catalogue (111)

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Device	Model / Reference	Registries	Class	Status
BiomarC® Restore	040155	EUDAMEDFDA UDI	Class II	Active
Carbon Bright ®	040154	FDA UDI	Class II	Active
BiomarC®	040314	FDA UDI	Class II	Active
Injection Procedure Kit	101088	FDA UDI	N/A	Active
MammoStar™	STAR1031	FDA UDI	Class II	Active
BiomarC ®	040101	FDA UDI	Class II	Unknown
BiomarC®	040101	FDA UDI	Class II	Active
Carbon Bright ®	040153	FDA UDI	Class II	Active
Durasphere ®	890-209	FDA UDI	Class II	Active
BiomarC®	040121	FDA UDI	Class II	Active
BiomarC®	040238	FDA UDI	Class II	Active
MammoStar™	STAR1001	FDA UDI	Class II	Active
BiomarC®	040400	FDA UDI	Class II	Unknown
BiomarC®	040126	FDA UDI	Class II	Active
MammoStar™	STAR1403	FDA UDI	Class II	Active
BiomarC®	040140	FDA UDI	Class II	Active
BiomarC®	040313	FDA UDI	Class II	Active
BiomarC®	040401	FDA UDI	Class II	Unknown
BiomarC®	040121	FDA UDI	Class II	Unknown
Biomarc ® Ex	040165	FDA UDI	Class II	Active
BiomarC®	040316	FDA UDI	Class II	Active
Biomarc ® Restore	040164	FDA UDI	Class II	Active
BiomarC®	040147	FDA UDI	Class II	Active
BiomarC®	040109	FDA UDI	Class II	Unknown
BiomarC®	040132	FDA UDI	Class II	Active
BiomarC®	040234	FDA UDI	Class II	Active
BiomarC®	040403	FDA UDI	Class II	Unknown
Durasphere ®	890-217	FDA UDI	Class II	Unknown
ImarC™	040201	FDA UDI	Class II	Unknown
BiomarC®	040402	FDA UDI	Class II	Unknown
Endoscopic Injection Needle	101087	FDA UDI	Class II	Active
Biomarc ® Restore	040163	FDA UDI	Class II	Active
BiomarC®	040167	FDA UDI	Class II	Active
BiomarC®	040321	FDA UDI	Class II	Active
MammoStar™	STAR1401	FDA UDI	Class II	Active
BiomarC®	040236	FDA UDI	Class II	Active
MammoStar™	STAR1033	FDA UDI	Class II	Active
BiomarC®	040115	FDA UDI	Class II	Active
MammoStar™	STAR0801	FDA UDI	Class II	Active
Imarc™	040304	FDA UDI	Class II	Unknown
BiomarC®	040139	FDA UDI	Class II	Active
BiomarC ®	040143	FDA UDI	Class II	Active
Carbon Medical Technologies Endoscopic Injection Needle	K042615	FDA 510(k)	Class II	Active
Biomarc Coaxial Needle	K133148	FDA 510(k)	Class II	Active
Dermmatrix Surgical Mesh	K021160	FDA 510(k)	Class II	Active
Biomarc Gold Tissue Marker	K070436	FDA 510(k)	Class II	Active
Modification To Biomarc Tissue Marker	K063193	FDA 510(k)	Class II	Active
MammoSTAR Biopsy Site Identifier	K251748	FDA 510(k)	Class II	Active
InjecSURE Injection System	K253598	FDA 510(k)	Class II	Active
Biomarc Fiducial Marker	K110772	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

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Authorities

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FDA Recalls (2)

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

Carbon Medical Technologies, Inc. has two FDA recall records initiated between December 16, 2022, and July 26, 2024. One recall involves mislabeling where the product is identified as STAR1401 (a 1x3mm Barbell marker) while the packaging contains STAR1402 (a 1x5mm Tribell marker). The other recall pertains to the omission of an MRI Insert that was supposed to be provided to the patient. The records show statuses of open, classified, and terminated.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Jul 26, 2024	Z-3161-2024	—	open, classified	This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.
Dec 16, 2022	Z-1041-2023	—	terminated	The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loaded in a 14 gauge needle, while the packaging contains STAR1402, a 1x5mm Tribell shaped marker pre-loaded in a 14 gauge needle.