J Ers Co L T D

FDA Filings

This page includes the latest FDA filings for J Ers Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
JDEW GREEN MOIST J'ers Co.,ltd, UCL Co., Ltd	Otc Medication	2018-09-18
JDEW GREEN MOIST TONER J'ers Co.,ltd, UCL Co., Ltd	Otc Medication	2018-09-18
JDEW HOMME ALL FOR YOU AQUA MARINE ALL IN ONE J'ers Co.,ltd, UCL Co., Ltd	Otc Medication	2018-09-18
NDC 72543-030 J'ers Co.,ltd	JDEW GREEN MOIST	2018-08-01
NDC 72543-020 J'ers Co.,ltd	JDEW GREEN MOIST TONER	2018-08-01
NDC 72543-010 J'ers Co.,ltd	JDEW HOMME ALL FOR YOU AQUA MARINE ALL IN ONE	2018-08-01

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• 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 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 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 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
• UCL Co., Ltd