E B

FDA Filings

This page includes the latest FDA filings for E B. 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
DAL CARA TONE UP SUN BASE E&B, EYESOME. Co.,Ltd.	Otc Medication	2020-03-31
DAL INNER FIT BB E&B, EYESOME. Co.,Ltd.	Otc Medication	2020-03-31
DAL MIOMIO MASK E&B, JaYeon Mapping Cosmetic Co.	Otc Medication	2020-03-30
DAL INNER CUSHION E&B, EYESOME. Co.,Ltd.	Otc Medication	2020-03-30
NDC 73759-040 E&B	DAL INNER FIT BB	2020-03-01
NDC 73759-030 E&B	DAL INNER CUSHION	2020-03-01
NDC 73759-020 E&B	DAL CARA TONE UP SUN BASE	2020-03-01
NDC 73759-010 E&B	DAL MIOMIO MASK	2020-03-01

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• Edwards LifeSciences LLCone Edwards Wayirvine, CA 92614 PMA NumberP220003 Date Received03/14/2022 Decision Date09/14/2022 Product Code NKM  Advisory Committee Cardiovascular Clinical TrialsNCT03706833 Expedited Review Granted? No
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• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614-5688 PMA NumberP150048 Supplement NumberS067 Date Received08/15/2022 Decision Date09/12/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP150036 Supplement NumberS063 Date Received08/15/2022 Decision Date09/12/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP860057 Supplement NumberS208 Date Received08/15/2022 Decision Date09/12/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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