FDA.reportPublic FDA data

CARBON MEDICAL TECHNOLOGIES, INC.

Matched from indexed company URL: Carbon, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21344943002619738CARBON MEDICAL TECHNOLOGIES, INC.1Y2026-01-011290 HAMMOND RD STE 2 Saint Paul MN US 55110
30338588583033858858CARBON (SHENZHEN) MEDICAL DEVICE CO., LTD.1N2026-01-01Room 203, Building B, 5# Skyworth Innovation Vally No. 1 Tangtou Road, Tangtou Community, Shiyan S Shenzhen Guangdong CN 518102

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
551991756126011P980053DURASPHERE INJECTABLE BULKING AGENTLNM1999-09-13
551991157608216K982890ADVANCED UROSCIENCE INJECTION NEEDLEFBK1998-10-26
551991668719195K253598InjecSURE Injection SystemFBK2026-03-31
551991630562607K251748MammoSTAR Biopsy Site IdentifierNEU2025-07-23
3329941677963296K243298Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound SystemIYN2025-04-03
3329941222883385K243296Disposable Biopsy NeedleKNW2025-07-11
551991486693338K211590Fiducial MarkerIYE2021-06-10
551991334191050K191797BiomarC Fiducial MarkerIYE2019-07-29
551991601527534K172227Endoscopic Injection NeedleFBK2017-08-23
551991510943082K133148BIOMARC COAXIAL NEEDLEFBK2014-05-13
551991165467219K132708BIOMARC FIDUCIAL MARKERNEU2013-12-20
551991608948300K132064BIOMARC FIDUCIAL MARKERIYE2014-02-28
551992070715787K130678BIOMARC GOLD FIDUCIAL MARKERIYE2013-04-12
551991813479916K110772BIOMARC FIDUCIAL MARKERIYE2011-04-28
551991056595073K100994PRELOADED TISSUE MARKER DEVICENEU2010-04-30
551991084325429K063193MODIFICATION TO BIOMARC TISSUE MARKERNEU2006-11-21
551991512587305K042296BIOMARC PRELOADED TISSUE MARKER DEVICENEU2004-09-20
551991873932986K002323ADVANCED UROSCIENCE INJECTION NEEDLEFBK2000-07-31
551991271775149
551991013061519
3329941036713960
551991336899663
551991377012593
3329941513921500

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FBK52026-03-31
NEU52025-07-23
IYE52021-06-10
KNW12025-07-11
IYN12025-04-03
LNM11999-09-13

PMA#

Durasphere Injectable Bulking Agent

2022-10-27

CARBON MEDICAL TECHNOLOGIES, INC.1290 Hammond Rd.st. Paul, MN 55110-5876 PMA NumberP980053 Supplement NumberS019 Date Received09/27/2022 Decision Date10/27/2022 Product Code LNM  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Suppl...

PMN#

GUDID#

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