FDA.reportPublic FDA data

C2Dx, Inc.

Matched from indexed company URL: C2DX, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30154897523015489752C2Dx, Inc.1N2026-01-01555 E Eliza St Suite A Schoolcraft MI US 49087

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850007350321Wire Guide - C-SF-15-50888-902-2239info@everismedical.com
00850007350338Salivary Access Dilator Set - SDDS-18-20-HC888-902-2239info@everismedical.com
00850007350345Kolenda Salivary Introducer Set - 5.0 - SDAS-5.0-18888-902-2239info@everismedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2274091611355011K844214COMPARTMENT SYNDROME PRESSURE MONITOR SYSLXC1985-04-04
2274091686145020K233185MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel SystemGEI2023-10-24
2274091727319091K183009HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADESGEI2018-11-26
2274091827768166K171764Fixed Core Wire GuidesDQX2018-03-09
2274091445415738K140593ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDEGCJ2014-12-15
2274091758693339K120468NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTORGCJ2012-07-06
2274092057369162K091107MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEMGEI2009-05-01
2274091534901803K073675T-PUMP LOCALIZED TEMPERATURE THERAPY PUMPILO2008-05-08
2274091111601306K002021HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADEGEI2000-08-24
2274091009657577
2274091886260046

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI42023-10-24
GCJ22014-12-15
DQX12018-03-09
ILO12008-05-08
LXC11985-04-04

PMN#

GUDID#

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