Johnson Johnson

FDA Filings

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

USA

NEW YORK STOCK EXCHANGE

JNJ

DUNS 001307081

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
TYLENOL COLD AND FLU R J General Corporation, Johnson & Johnson	Otc Medication	2023-10-17
MOTRIN IB R J General Corporation, Johnson & Johnson	Otc Medication	2023-10-17
TYLENOL EXTRA STRENGTH R J General Corporation, Johnson & Johnson	Otc Medication	2023-10-17
TYLENOL SINUS SEVERE R J General Corporation, Johnson & Johnson	Otc Medication	2023-10-17
TYLENOL COLD AND FLU R J General Corporation, Johnson & Johnson	Otc Medication	2022-12-26
MOTRIN IB R J General Corporation, Johnson & Johnson	Otc Medication	2022-12-26
TYLENOL EXTRA STRENGTH R J General Corporation, Johnson & Johnson	Otc Medication	2022-12-26
TYLENOL SINUS SEVERE R J General Corporation, Johnson & Johnson	Otc Medication	2022-12-26
PMN K142460 JOHNSON AND JOHNSON	EXPEDIUM Spine System/Synapse System	2014-10-01
PMN K113273 JOHNSON & JOHNSON	SPOTLIGHT ACCESS SYSTEM	2012-01-27
PMN K112913 JOHNSON & JOHNSON	SPOTLIGHT ACCESS SYSTEM	2011-12-16
PMN K113348 JOHNSON & JOHNSON	COUGAR SYSTEM	2011-12-13
PMN K110551 JOHNSON & JOHNSON	EXPEDIUM SPINE SYSTEM	2011-10-26
PMN K110694 JOHNSON & JOHNSON	CONCORDE BULLET SPINAL SYSTEM	2011-10-11
PMN K111571 JOHNSON & JOHNSON	VIPER SYSTEMS	2011-07-06
PMN K110454 JOHNSON & JOHNSON	COUGAR LS LATERAL CAGE SYSTEM	2011-05-13
PMN K103743 JOHNSON & JOHNSON	CONCORDE CURVE SYSTEM	2011-03-17
PMN K103488 JOHNSON AND JOHNSON	CONCORDE BULLET CAGE SYSTEM	2011-03-02
PMN K103490 JOHNSON & JOHNSON	EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM	2011-02-17
050594 NDA JOHNSON AND JOHNSON		0000-00-00 00:00:00
050518 NDA JOHNSON AND JOHNSON		0000-00-00 00:00:00
050448 NDA JOHNSON AND JOHNSON		0000-00-00 00:00:00
021812 NDA JOHNSON AND JOHNSON		0000-00-00 00:00:00
020834 NDA JOHNSON AND JOHNSON		0000-00-00 00:00:00
020485 NDA JOHNSON AND JOHNSON		0000-00-00 00:00:00
019501 NDA JOHNSON AND JOHNSON		0000-00-00 00:00:00
019407 NDA JOHNSON AND JOHNSON		0000-00-00 00:00:00
019002 NDA JOHNSON AND JOHNSON		0000-00-00 00:00:00

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• Johnson & Johnson Surgical Vision, Inc.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP980040 Supplement NumberS154 Date Received11/17/2022 Decision Date12/15/2022 Product Code HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Johnson & Johnson Surgical Vision, Inc.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP980040 Supplement NumberS155 Date Received11/18/2022 Decision Date12/12/2022 Product Code HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Johnson & Johnson Surgical Vision, Inc.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP080010 Supplement NumberS021 Date Received11/09/2022 Decision Date12/06/2022 Product Code MFK  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Johnson & Johnson Surgical Vision, Inc.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP880081 Supplement NumberS047 Date Received11/09/2022 Decision Date12/06/2022 Product Code HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Johnson & Johnson Surgical Vision, Inc.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990080 Supplement NumberS056 Date Received11/09/2022 Decision Date12/06/2022 Product Code HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Johnson & Johnson Surgical Vision, Inc.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP980040 Supplement NumberS152 Date Received10/25/2022 Decision Date11/17/2022 Product Code HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Johnson & Johnson Surgical Vision, Inc.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP980040 Supplement NumberS151 Date Received09/28/2022 Decision Date10/27/2022 Product Code HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Johnson & Johnson Surgical Vision, Inc.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP980040 Supplement NumberS150 Date Received09/12/2022 Decision Date10/07/2022 Product Code HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Johnson & Johnson Surgical Vision, Inc.1700 E. St. Andrew Placesanta Ana, CA 92705 PMA NumberP980040 Supplement NumberS149 Date Received07/01/2022 Decision Date07/25/2022 Product Code HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Johnson & Johnson Surgical Vision, Inc.1700 E. St. Andrew Placesanta Ana, CA 92705 PMA NumberP980040 Supplement NumberS148 Date Received06/24/2022 Decision Date07/20/2022 Product Code HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Johnson & Johnson Surgical Vision, Inc.1700 E. St. Andrew Placesanta Ana, CA 92705 PMA NumberP980040 Supplement NumberS147 Date Received04/28/2022 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
• Johnson & Johnson Surgical Vision, Inc.1700 E. St. Andrew Placesanta Ana, CA 92705 PMA NumberP980040 Supplement NumberS146 Date Received03/02/2022 Decision Date03/30/2022 Product Code HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• R J General Corporation
• Johnson & Johnson International Inc.
• Johnson & Johnson Medical GmbH

Related Finance Registrations

NCAGE Code	1F385	JOHNSON AND JOHNSON
NCAGE Code	1L553	JOHNSON AND JOHNSON
NCAGE Code	7CDG6	JOHNSON AND JOHNSON
NCAGE Code	77WW6	JOHNSON & JOHNSON
NCAGE Code	Z6Q01	JOHNSON & JOHNSON
CAGE Code	1L553	JOHNSON AND JOHNSON
CAGE Code	1F385	JOHNSON AND JOHNSON
CAGE Code	Z6Q01	JOHNSON & JOHNSON
CAGE Code	77WW6	JOHNSON & JOHNSON
CAGE Code	7CDG6	JOHNSON AND JOHNSON
SEC	0000200406	JOHNSON & JOHNSON of NEW JERSEY