510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Carbon Medical Technologies, Inc.

Saint Paul, MN, US

CARBON MEDICAL TECHNOLOGIES, INC. appears in FDA device records in Saint Paul, MN. FDA records list 18 510(k) clearances between and , 21 PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
18
PMA records
21
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 18 510(k) clearances for Carbon Medical Technologies, Inc. between 2002 and 2026. The busiest year on record is 2003, with 2. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Carbon Medical Technologies, Inc., by decision year
YearClearances
20021
20032
20042
20061
20071
20101
20111
20132
20142
20171
20191
20211
20251
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253598InjecSURE Injection SystemFBKSubstantially Equivalent
K251748MammoSTAR Biopsy Site IdentifierNEUSubstantially Equivalent
K211590Fiducial MarkerIYESubstantially Equivalent
K191797BiomarC Fiducial MarkerIYESubstantially Equivalent
K172227Endoscopic Injection NeedleFBKSubstantially Equivalent
K133148BIOMARC COAXIAL NEEDLEFBKSubstantially Equivalent
K132064BIOMARC FIDUCIAL MARKERIYESubstantially Equivalent
K132708BIOMARC FIDUCIAL MARKERNEUSubstantially Equivalent
K130678BIOMARC GOLD FIDUCIAL MARKERIYESubstantially Equivalent
K110772BIOMARC FIDUCIAL MARKERIYESubstantially Equivalent
K100994PRELOADED TISSUE MARKER DEVICENEUSubstantially Equivalent
K070436BIOMARC GOLD TISSUE MARKERNEUSubstantially Equivalent
K063193MODIFICATION TO BIOMARC TISSUE MARKERNEUSubstantially Equivalent
K042615CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLEFBKSubstantially Equivalent
K042296BIOMARC PRELOADED TISSUE MARKER DEVICENEUSubstantially Equivalent
K032347BIOMARC TISSUE MARKERGDWSubstantially Equivalent
K030451CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLEFBKSubstantially Equivalent
K021160DERMMATRIX SURGICAL MESHFTMSubstantially Equivalent

Registered establishments

FDA registered establishments for Carbon Medical Technologies, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
21344943002619738CARBON MEDICAL TECHNOLOGIES, INC.1290 HAMMOND RD STE 2, Saint Paul, MN 55110 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-3161-2024BiomarC EX Fiducial Marker System, Catalog Number 040165This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.Class IIIOpen, Classified
Z-1041-2023Mammotome MammoStar Biopsy Site Identified, REF STAR1401The 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.Class IITerminated

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Carbon Medical Technologies, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain