CARBON MEDICAL TECHNOLOGIES, INC.

FDA Device Registration & Listing · Saint Paul, MN, US · Registration 2134494

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2134494
FEI Number
3002619738
Entity Name
CARBON MEDICAL TECHNOLOGIES, INC.
City/State/Country
Saint Paul, MN, US
Establishment Address
1290 HAMMOND RD STE 2, Saint Paul, MN 55110, US
Establishment Type(s)
Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Carbon Medical Technologies, Inc. (Owner Number: 9034784)
Owner / Operator Contact Address
1290 Hammond Road, --, Saint Paul, MN 55110, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K211590
PMA Number
N/A

All Registered Proprietary Names

BiomarC PRO Marker / Marker System Durasphere Injectable Bulking Agent InjecSURE Injection System BiomarC Tissue Marker System BiomarC Preloaded Tissue Marker Dev BiomarC Tissue Marker Device BiomarC Gold Fiducial Marker BiomarC PRO Marker / Marker System BiomarC EX Marker / Marker System MammoSTAR Biopsy Site Identifier BiomarC Tissue Marker System BiomarC Tissue Marker Injection Needle Durasphere Injection Needle BiomarC Fiducial Marker / Marker System BiomarC Coaxial Needle

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2014-01-29
LNM Agent, Bulking, Injectable For Gastro-Urology Use Unknown Class 3 N/A 2007-12-10
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2026-04-02
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2007-12-10
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2007-12-10
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2010-06-22
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2013-07-03
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2019-11-08
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2019-11-08
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2014-05-20
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2025-07-31
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2007-12-10
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2007-12-10
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2015-11-10
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2014-10-03
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2014-10-03
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2007-12-10
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2012-11-16
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2012-11-16
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2021-11-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Carbon Medical Technologies, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K131563 Opus Ksd, Inc. SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM 2014-04-09
K131705 Covidien, Formerly US Surgical A Divison of Tyco H ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY 2013-07-01
K103263 Covidien, Formerly US Surgical A Divison of Tyco H ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY 2010-11-22
K130717 Covidien, Formerly US Surgical A Divison of Tyco H ENDO GIA RELOAD 2013-04-18
K221006 Covidien GIA Stapler with Tri-Staple Technology 2022-04-29

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0040-06 Boston Scientific Corporation 3
Enteryx Procedure Kit Order No.: M00572600 -US and M00572500 -OUS
Z-0020-2023 Hobbs Medical, Inc. 2
Hobbs Posi-Stop Injection Needle Catalog Number: 4702
Z-0021-2023 Hobbs Medical, Inc. 2
Hobbs Posi-Stop Injection Needle Catalog Number: 4704
Z-0022-2023 Hobbs Medical, Inc. 2
Hobbs Posi-Stop Injection Needle Catalog Number: 4712
Z-0023-2023 Hobbs Medical, Inc. 2
Hobbs Posi-Stop Injection Needle Catalog Number: 4718

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2134494. Last updated year: 2026. Please use registration number 2134494 when referencing this establishment in official correspondence.
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