Data / Medical devices / United States / Carbon Medical Technologies, Inc.
Carbon Medical Technologies, Inc.: FDA-registered device maker in Saint Paul, MN, United States, 14 510(k) clearances and 1 PMA approval
Carbon Medical Technologies, Inc. is registered with the FDA (registration 2134494) in Saint Paul, MN, United States. It lists 5 device types. The FDA files 14 510(k) clearances and 1 PMA approval under its listings, the newest dated March 31, 2026. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2134494
- FEI number
- 3002619738
- Address
- 1290 Hammond RD Ste 2, Saint Paul, MN, United States, 55110
- Owner or operator
- Carbon Medical Technologies, Inc. (9034784)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- December 10, 2007
- Registered through
- 2026
- Brand names listed
- BiomarC Coaxial Needle, BiomarC EX Marker / Marker System, BiomarC Fiducial Marker / Marker System, BiomarC Gold Fiducial Marker, BiomarC PRO Marker / Marker System, BiomarC Preloaded Tissue Marker Dev, BiomarC Tissue Marker, BiomarC Tissue Marker Device and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Agent, Bulking, Injectable For Gastro-Urology Use | LNM | 3 | Manufacturer | accessdata.fda.gov |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Marker, Radiographic, Implantable | NEU | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Staple, Implantable | GDW | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 31, 2026 | K253598 | InjecSURE Injection System | FBK | Substantially Equivalent | Carbon Medical Technologies, Inc. | accessdata.fda.gov |
| July 23, 2025 | K251748 | MammoSTAR Biopsy Site Identifier | NEU | Substantially Equivalent | Carbon Medical Technologies, Inc. | accessdata.fda.gov |
| June 10, 2021 | K211590 | Fiducial Marker | IYE | Substantially Equivalent | Carbon Medical Technologies, Inc. | accessdata.fda.gov |
| July 29, 2019 | K191797 | BiomarC Fiducial Marker | IYE | Substantially Equivalent | Carbon Medical Technologies | accessdata.fda.gov |
| May 13, 2014 | K133148 | BIOMARC COAXIAL NEEDLE | FBK | Substantially Equivalent | Carbon Medical Technologies, Inc. | accessdata.fda.gov |
| February 28, 2014 | K132064 | BIOMARC FIDUCIAL MARKER | IYE | Substantially Equivalent | Carbon Medical Technologies, Inc. | accessdata.fda.gov |
| December 20, 2013 | K132708 | BIOMARC FIDUCIAL MARKER | NEU | Substantially Equivalent | Carbon Medical Technologies, Inc. | accessdata.fda.gov |
| April 12, 2013 | K130678 | BIOMARC GOLD FIDUCIAL MARKER | IYE | Substantially Equivalent | Carbon Medical Technologies, Inc. | accessdata.fda.gov |
| April 28, 2011 | K110772 | BIOMARC FIDUCIAL MARKER | IYE | Substantially Equivalent | Carbon Medical Technologies, Inc. | accessdata.fda.gov |
| April 30, 2010 | K100994 | PRELOADED TISSUE MARKER DEVICE | NEU | Substantially Equivalent | Carbon Medical Technologies, Inc. | accessdata.fda.gov |
| November 21, 2006 | K063193 | MODIFICATION TO BIOMARC TISSUE MARKER | NEU | Substantially Equivalent | Carbon Medical Technologies, Inc. | accessdata.fda.gov |
| September 20, 2004 | K042296 | BIOMARC PRELOADED TISSUE MARKER DEVICE | NEU | Substantially Equivalent | Carbon Medical Technologies, Inc. | accessdata.fda.gov |
| July 31, 2000 | K002323 | ADVANCED UROSCIENCE INJECTION NEEDLE | FBK | Substantially Equivalent | Advanced Uroscience, Inc. | accessdata.fda.gov |
| October 26, 1998 | K982890 | ADVANCED UROSCIENCE INJECTION NEEDLE | FBK | Substantially Equivalent | Advanced Uroscience, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 13, 1999 | P980053 | DURASPHERE INJECTABLE BULKING AGENT | LNM | 20 | March 13, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 26, 2024 | 95179 | Class III | Ongoing | BiomarC EX Fiducial Marker System, Catalog Number 040165 | This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient. | accessdata.fda.gov |
| December 16, 2022 | 91419 | Class II | Terminated | Mammotome MammoStar Biopsy Site Identified, REF STAR1401 | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Accelerator, Linear, Medical
- All makers of Marker, Radiographic, Implantable
- All makers of Endoscopic Injection Needle, Gastroenterology-Urology
- All makers of Staple, Implantable
- All makers of Agent, Bulking, Injectable For Gastro-Urology Use
Updated March 31, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.