Alcon

FDA Filings

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

FDA Registration(s)

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMA P950008S015 ALCON	Silikon 1000	2021-02-15
PMN K063583 ALCON	ALCON VISION SYSTEM	2008-05-09
9951c888-4b6a-4c76-a9c1-dc3a0c777191 Alcon	Prescription Medication	2008-03-13
863fb43c-dd33-485b-9385-744db7a98b83 Alcon	Prescription Medication	2008-03-13
7218af16-9378-472a-a033-4c9f9d5524db Alcon	Prescription Medication	2008-03-13
5a5d8fee-b42a-4f0c-a508-75c7c71bedb4 Alcon	Prescription Medication	2008-03-13
31b9b263-11fd-4495-83dd-ababf0d70e9e Alcon	Prescription Medication	2008-03-13
PMN K981574 ALCON	OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION	1998-07-06
091574 ANDA ALCON		0000-00-00 00:00:00
087771 ANDA ALCON		0000-00-00 00:00:00
087547 ANDA ALCON		0000-00-00 00:00:00
083342 ANDA ALCON		0000-00-00 00:00:00
080229 ANDA ALCON		0000-00-00 00:00:00
080021 ANDA ALCON		0000-00-00 00:00:00
080020 ANDA ALCON		0000-00-00 00:00:00
062628 ANDA ALCON		0000-00-00 00:00:00
062339 ANDA ALCON		0000-00-00 00:00:00
061648 ANDA ALCON		0000-00-00 00:00:00
061645 ANDA ALCON		0000-00-00 00:00:00
050456 NDA ALCON		0000-00-00 00:00:00
050344 NDA ALCON		0000-00-00 00:00:00
020742 NDA ALCON		0000-00-00 00:00:00
020619 NDA ALCON		0000-00-00 00:00:00
020226 NDA ALCON		0000-00-00 00:00:00
019387 NDA ALCON		0000-00-00 00:00:00
018796 NDA ALCON		0000-00-00 00:00:00
018469 NDA ALCON		0000-00-00 00:00:00
017063 NDA ALCON		0000-00-00 00:00:00
016968 NDA ALCON		0000-00-00 00:00:00
014169 NDA ALCON		0000-00-00 00:00:00
012111 NDA ALCON		0000-00-00 00:00:00
005319 NDA ALCON		0000-00-00 00:00:00

Similar & Related FDA Registered Companies

ALCON Laboratories Inc.
Alcon Labs
ALCONOX, INC.
Alcon Research, LLC
Alcon Research, Ltd.
ALCON RESEARCH, LTD. DBA ALCON LABORATORIES, INC.
ALCON LENSX, INC.
ALCON MANUFACTURING, LTD.
ALCON, INC.
ALCON LABORATORIES
ALCON UNIVERSAL, LTD.
ALCON SURGICAL, INC.
ALCON LABORATORIES, INC.6201 South Freeway Dr.fort Worth, TX 76134 PMA NumberP930014 Supplement NumberS144 Date Received11/22/2022 Decision Date12/20/2022 Product Code HQL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Alcon Laboratories, LLC6201 South Freewayfort Worth, TX 76134 PMA NumberP190018 Supplement NumberS021 Date Received11/22/2022 Decision Date12/20/2022 Product Codes MJP HQL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Alcon Research, Ltd.6201 South Freewayfort Worth, TX 76134-2099 PMA NumberP040020 Supplement NumberS104 Date Received11/22/2022 Decision Date12/20/2022 Product Code MFK Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
ALCON LABORATORIES6201 South Freewayfort Worth, TX 76134 PMA NumberP990023 Supplement NumberS018 Date Received08/24/2022 Decision Date09/22/2022 Product Code LZP Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
ALCON LABORATORIES6201 S Freewayft Worth, TX 76134 PMA NumberP840064 Supplement NumberS078 Date Received08/23/2022 Decision Date09/15/2022 Product Code LZP Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
ALCON LABORATORIES6201 South Freewayfort Worth, TX 76134 PMA NumberP990023 Supplement NumberS017 Date Received08/23/2022 Decision Date09/15/2022 Product Code LZP Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Alcon Research, Ltd.6201 South Freeway, R3-48fort Worth, TX 76134-2099 PMA NumberP890047 Supplement NumberS059 Date Received08/23/2022 Decision Date09/15/2022 Product Code LZP Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
ALCON LABORATORIES6201 S Freewayft Worth, TX 76134 PMA NumberP840064 Supplement NumberS077 Date Received08/17/2022 Decision Date09/13/2022 Product Code LZP Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Alcon Research, Ltd.6201 South Freeway, R3-48fort Worth, TX 76134-2099 PMA NumberP890047 Supplement NumberS058 Date Received08/17/2022 Decision Date09/13/2022 Product Code LZP Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
ALCON LABORATORIES6201 South Freeway R3-48fort Worth, TX 76134 PMA NumberP950018 Supplement NumberS021 Date Received07/18/2022 Decision Date08/12/2022 Product Code LWL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Alcon Laboratories, Inc.6201 South Freewayfort Worth, TX 76134-2099 PMA NumberP010019 Supplement NumberS083 Date Received06/09/2022 Decision Date07/06/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
ALCON LABORATORIES, INC.6201 South Freeway Dr.fort Worth, TX 76134 PMA NumberP930014 Supplement NumberS143 Date Received04/22/2022 Decision Date05/18/2022 Product Code HQL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Alcon Laboratories, LLC6201 South Freewayfort Worth, TX 76134 PMA NumberP190018 Supplement NumberS020 Date Received04/22/2022 Decision Date05/18/2022 Product Codes HQL MJP Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Alcon Research, Ltd.6201 South Freewayfort Worth, TX 76134-2099 PMA NumberP040020 Supplement NumberS103 Date Received04/22/2022 Decision Date05/18/2022 Product Code MFK Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Alcon Laboratories, LLC6201 South Freewayfort Worth, TX 76134 PMA NumberP190018 Supplement NumberS019 Date Received04/06/2022 Decision Date05/03/2022 Product Codes MJP HQL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
ALCON LABORATORIES, INC.6201 South Freeway Dr.fort Worth, TX 76134 PMA NumberP930014 Supplement NumberS142 Date Received03/01/2022 Decision Date03/25/2022 Product Code HQL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Alcon Research, Ltd.6201 South Freewayfort Worth, TX 76134-2099 PMA NumberP040020 Supplement NumberS102 Date Received03/01/2022 Decision Date03/25/2022 Product Code MFK Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	B8133	ALCON
NCAGE Code	H0P28	ALCON
CAGE Code	H0P28	ALCON
CAGE Code	B8133	ALCON

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018012938608	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	PATIENT ID CARDS	1 PCS

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