Codonics Inc

FDA Filings

This page includes the latest FDA filings for Codonics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 1530958
• FEI Number: 1000639866
• Name: CODONICS, INC.
• Owner & Operator: CODONICS, INC.
• Contact Address: 17991 ENGLEWOOD DR. --; Middleburg Heights OH 44130 US
• Official Correspondent:
  • ALAN - DE SANTIS
  • x-440-2431198-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 17991 ENGLEWOOD DR. ; Cleveland, OH 44130 US
• Establishment Type:
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00814905020427 CODONICS INC.	Codonics Virtua® C Controller - 92C	2023-10-05
GUDID 00814905020410 CODONICS INC.	Codonics Virtua® XR Controller - 76C	2023-10-05
GUDID 00814905020403 CODONICS INC.	Codonics Virtua® XR Controller - 72C	2023-10-05
GUDID 00814905020397 CODONICS INC.	Codonics Virtua® Controller - 75C	2023-10-05
GUDID 00814905020380 CODONICS INC.	Codonics Virtua® Controller - 71C	2023-10-05
GUDID 00814905020359 CODONICS INC.	Codonics Virtua® C/E Medical Disc Publisher	2023-10-05
GUDID 00814905020342 CODONICS INC.	Codonics Virtua® C Controller - 90C	2023-10-05
GUDID 00814905020335 CODONICS INC.	Codonics Virtua® XR Medical Disc Publisher	2023-10-05
GUDID 00814905020328 CODONICS INC.	Codonics Virtua® Medical Disc Publisher	2023-10-05
GUDID 00814905020311 CODONICS INC.	Codonics Virtua® C Controller - 91C	2023-10-05
GUDID 00814905020304 CODONICS INC.	Codonics Virtua® XR Controller - 74C	2023-10-05
GUDID 00814905020298 CODONICS INC.	Codonics Virtua® Controller - 73C	2023-10-05
GUDID 00814905021103 CODONICS INC.	Codonics Safe Label System®(SLS) 600i Point of Care Station - 170C	2023-06-16
GUDID 10814905021117 CODONICS INC.	Codonics Thermal GS Paper/White Film, 810	2021-05-25
GUDID 10814905021056 CODONICS INC.	Codonics DirectVista Thermal Film, 810-DVC	2021-05-25
GUDID 00814905021042 CODONICS INC.	Codonics DirectVista Thermal Film, 810-DVB	2021-05-25
GUDID 10814905020950 CODONICS INC.	Codonics DirectVista Thermal Film, 1451-DVB5	2020-02-13
GUDID 10814905020943 CODONICS INC.	Codonics DirectVista Thermal Film, 1436-DVB5	2020-02-13
GUDID 10814905020936 CODONICS INC.	Codonics DirectVista Thermal Film, 810-DVB5	2020-02-13
GUDID 10814905020929 CODONICS INC.	Codonics DirectVista Thermal Film, 1114-DVB5	2020-02-13
GUDID 10814905020899 CODONICS INC.	Codonics DirectVista Thermal Film, 1114-DVB5	2020-02-13
GUDID 10814905020882 CODONICS INC.	Codonics DirectVista Thermal Film, 1417-DVB5	2020-02-13
GUDID 10814905020738 CODONICS INC.	Codonics ChromaVista Paper/WhiteFilm, A-CVP	2020-02-13
GUDID 10814905020721 CODONICS INC.	Codonics DirectVista Paper/White Film, 1114-DVP	2020-02-13
GUDID 10814905020714 CODONICS INC.	Codonics DirectVista Paper/White Film, 1417-DVP	2020-02-13
GUDID 10814905020691 CODONICS INC.	Codonics DirectVista Paper/White Film, A-DVP	2020-02-13
GUDID 10814905020684 CODONICS INC.	Codonics DirectVista Thermal Film, 810-DVBT	2020-02-13
GUDID 10814905020677 CODONICS INC.	Codonics DirectVista Thermal Film, 1417-DVBT	2020-02-13
GUDID 10814905020660 CODONICS INC.	Codonics DirectVista Thermal Film, 1451-DVB	2020-02-13
GUDID 10814905020646 CODONICS INC.	Codonics DirectVista Thermal Film, 810-DVC	2020-02-13
GUDID 10814905020639 CODONICS INC.	Codonics DirectVista Thermal Film, 810-DVB	2020-02-13
GUDID 10814905020622 CODONICS INC.	Codonics DirectVista Thermal Film, 1114-DVB	2020-02-13
GUDID 10814905020615 CODONICS INC.	Codonics DirectVista Thermal Film, 1417-DVC	2020-02-13
GUDID 00814905020915 CODONICS INC.	Codonics DirectVista Thermal Film, 1417-DVB5	2020-02-13
GUDID 00814905020908 CODONICS INC.	Codonics DirectVista Thermal Film, 810-DVB5	2020-02-13
GUDID 00814905020748 CODONICS INC.	Codonics ChromaVista Paper/WhiteFilm, A4-CVP	2020-02-13
GUDID 00814905020700 CODONICS INC.	Codonics DirectVista Paper/White Film, A4-DVP	2020-02-13
GUDID 00814905020656 CODONICS INC.	Codonics DirectVista Thermal Film, 1436-DVB	2020-02-13
GUDID 00814905020601 CODONICS INC.	Codonics DirectVista Thermal Film, 1417-DVB	2020-02-13
GUDID 00814905020823 CODONICS INC.	Codonics Safe Label System®(SLS) 550i Point of Care Station - 144C	2018-11-05
GUDID 00814905020373 CODONICS INC.	Codonics Safe Label System®(SLS) 550i Point of Care Station	2018-07-06
GUDID 00814905020366 CODONICS INC.	Codonics Safe Label System®(SLS) 550i Point of Care Station	2018-07-06
GUDID 00814905020267 CODONICS INC.	Codonics Horizon® Operating Software	2018-07-06
GUDID 00814905020250 CODONICS INC.	Codonics Safe Label System®(SLS) 500i Point of Care Station	2018-07-06
GUDID 00814905020243 CODONICS INC.	Codonics Safe Label System®(SLS) 500i Point of Care Station	2018-07-06
GUDID 00814905020236 CODONICS INC.	Codonics Safe Label System®(SLS) 500i Point of Care Station	2018-07-06
GUDID 00814905020229 CODONICS INC.	Codonics Safe Label System®(SLS) 500i Point of Care Station	2018-07-06
GUDID 00814905020212 CODONICS INC.	Codonics Horizon® Multi-media Imager	2018-07-06
GUDID 00814905020205 CODONICS INC.	Codonics Horizon® Multi-media Imager	2018-07-06
GUDID 00814905020199 CODONICS INC.	Codonics Horizon® Multi-media Imager	2018-07-06
GUDID 00814905020182 CODONICS INC.	Codonics Horizon® Multi-media Imager	2018-07-06
GUDID 00814905020175 CODONICS INC.	Codonics Horizon® Multi-media Imager	2018-07-06
GUDID 00814905020168 CODONICS INC.	Codonics Horizon® Multi-media Imager	2018-07-06
GUDID 00814905020151 CODONICS INC.	Codonics Horizon® Multi-media Imager	2018-07-06
GUDID 00814905020144 CODONICS INC.	Codonics Safe Label System® Administration Tool	2018-07-06
GUDID 00814905020137 CODONICS INC.	Codonics SLS500i Operating Software	2018-07-06
GUDID 00814905020120 CODONICS INC.	Codonics Horizon® XL Multi-media Imager	2018-07-06
GUDID 00814905020113 CODONICS INC.	Codonics Horizon® SF Multi-media Imager	2018-07-06
GUDID 00814905020106 CODONICS INC.	Codonics Horizon® GS Multi-media Imager	2018-07-06
GUDID 00814905020090 CODONICS INC.	Codonics Horizon® G2 Multi-media Imager	2018-07-06
GUDID 00814905020083 CODONICS INC.	Codonics Horizon® G1 Multi-media Imager	2018-07-06
GUDID 00814905020076 CODONICS INC.	Codonics Horizon® Ci Multi-media Imager	2018-07-06
GUDID 00814905020069 CODONICS INC.	Codonics Horizon® Operating Software	2018-07-06
GUDID 00814905020052 CODONICS INC.	Codonics Horizon® Operating Software	2018-07-06
GUDID 00814905020045 CODONICS INC.	Codonics Horizon® Operating Software	2018-07-06
GUDID 00814905020038 CODONICS INC.	Codonics Safe Label System® Administration Tool	2018-07-06
GUDID 00814905020021 CODONICS INC.	Codonics SLS500i Operating Software	2018-07-06
GUDID 00814905020014 CODONICS INC.	Codonics SLS500i Operating Software	2018-07-06
GUDID 00814905020007 CODONICS INC.	Codonics SLS500i Operating Software	2018-07-06
LRJ CODONICS, INC.	MoonBeam3, Sky6Xi,Sky 7Xi	2015-12-16
LRJ CODONICS, INC.	MoonBeam3, Sky6Xi, Sky7Xi	2015-12-16
PMN K101439 | BSZ CODONICS, INC.	CODONICS SAFE LABELING SYSTEM (SLS) SLS-500i, SLS-500P, SLS-XXX, Point of Care Station (PCS)	2011-02-11
PMN K101439 CODONICS, INC.	CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P	2011-02-07
PMN K962364 | LMC CODONICS, INC.	NP 1660, EP 1600	2007-12-05
PMN K030690 | LMC CODONICS, INC.	EP1000 Imager	2007-12-05
PMN K021054 | LMC CODONICS, INC.	Horizon Multimedia Imager Ci	2007-12-05
PMN K003481 | LMC CODONICS, INC.	NP 1660 Multimedia Imager	2007-12-05
PMN K060440 CODONICS, INC.	CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGER	2006-03-16
PMN K042232 CODONICS, INC.	NP-2600 SERIES HARDCOPY PRINTERS	2004-10-05
PMN K030690 CODONICS, INC.	CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS	2003-04-30
IWZ CODONICS, INC.	Direct Vista Clear,Direct Vista White Film,Chroma Vista White Film	2003-03-18
IWZ CODONICS, INC.	Direct Vista Blue Blue Film,Direct Vista Blue-T(DVBT),Direct Vista Blue-5(DVB5)	2003-03-18
PMN K021054 CODONICS, INC.	CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGER	2002-05-09
PMN K003481 CODONICS, INC.	CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 1660	2001-01-19
PMN K060440 | LMC CODONICS, INC.	Horizon Multimedia Long Film XL	1999-02-19
PMN K962364 CODONICS, INC.	CODONICS MEDICAL PRINTER (NP-1600M,NP1600MD)	1996-11-08

Related Finance Registrations

NCAGE Code	0CR58	CODONICS INC.
CAGE Code	0CR58	CODONICS INC.
S.A.M. Registration	0CR58 [101533727]	CODONICS INC.
DUNS	101533727	CODONICS INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092445237	Tokyo ,Japan -> Los Angeles, California	PLATES, SHEETS, PLASTIC NONCELLULR	887 PKG
2020092267590	Tokyo ,Japan -> Los Angeles, California	PLATES, SHEETS, PLASTIC NONCELLULR	887 PKG
2020091966391	Tokyo ,Japan -> Los Angeles, California	PLATES, SHEETS, PLASTIC NONCELLULR	887 PKG
2020091825006	Hong Kong,Hong Kong -> Long Beach, California	BALLHEAD	3 CTN
2020091858626	Tokyo ,Japan -> Los Angeles, California	PLATES, SHEETS, PLASTIC NONCELLULR	887 PKG
2020091244696	Hong Kong,Hong Kong -> Long Beach, California	BALLHEAD	3 CTN
2020091161771	Hong Kong,Hong Kong -> Long Beach, California	BALLHEAD	3 CTN
2020082247944	Tokyo ,Japan -> Los Angeles, California	COATED WRITING PAPER DAINIPPON PAPER (CV-PAPER WITH PERFORATION, ANTI-STATIC WITH WATER MARK) HS CODE : 4810.14 ACCEPTED BY KOBE CUSTOMS APPROVAL DATE: 2020/7/17	128 CTN