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Sign in to claim this brandCarbon 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?
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, as these are the device categories explicitly stated in the provided data.
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
- [email protected]
- Phone
- 1 651 653 8512
- PRRC Contact
- ERIC FURLICH
- EUDAMED SRN
- US-MF-000044355
- FDA FEI Number
- 3002619738
- DUNS Number
- —
Catalogue (111)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Fiducial Marker | K211590 | FDA 510(k) | Class II | Active |
| Biomarc Preloaded Tissue Marker Device | K042296 | FDA 510(k) | Class II | Active |
| Biomarc Gold Fiducial Marker | K130678 | EUDAMEDFDA 510(k) | Class II | Active |
| Biomarc Tissue Marker | K032347 | FDA 510(k) | Class II | Active |
| Preloaded Tissue Marker Device | K100994 | FDA 510(k) | Class II | Active |
| BiomarC Fiducial Marker | K191797 | FDA 510(k) | Class II | Active |
| Biomarc Fiducial Marker | K132064 | FDA 510(k) | Class II | Active |
| Biomarc Fiducial Marker | K132708 | EUDAMEDFDA 510(k) | Class II | Active |
| Endoscopic Injection Needle | K172227 | FDA 510(k) | Class II | Active |
| Carbon Medical Technologies Injection Needle | K030451 | FDA 510(k) | Class II | Active |
| Durasphere Injectable Bulking Agent | P980053 | FDA PMA | Class III | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
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. |