Inspire M D L T D

FDA Filings

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

ISRAEL

NYSE-CTA BATS EDGX EXCHANGE, INC.

NSPR

DUNS 514477996

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
GUDID 07290120281981 INSPIRE M.D LTD	CGuard Prime Carotid Stent System CND1040	2025-07-10
GUDID 07290120281974 INSPIRE M.D LTD	CGuard Prime Carotid Stent System CND1030	2025-07-10
GUDID 07290120281943 INSPIRE M.D LTD	CGuard Prime Carotid Stent System CND0940	2025-07-10
GUDID 07290120281936 INSPIRE M.D LTD	CGuard Prime Carotid Stent System CND0930	2025-07-10
GUDID 07290120281905 INSPIRE M.D LTD	CGuard Prime Carotid Stent System CND0840	2025-07-10
GUDID 07290120281899 INSPIRE M.D LTD	CGuard Prime Carotid Stent System CND0830	2025-07-10

Similar & Related FDA Registered Companies

• Inspire (Zhejiang) Medical Apparatus Co., Ltd
• INSPIRED MEDICAL PRODUCTS LTD.
• INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS093 Date Received11/18/2022 Decision Date12/16/2022 Product Code MNQ  Advisory Committee Anesthesiology Clinical TrialsNCT04457154 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS088 Date Received07/29/2022 Decision Date08/19/2022 Product Code MNQ  Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS084 Date Received05/20/2022 Decision Date06/16/2022 Product Code MNQ  Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS083 Date Received03/15/2022 Decision Date04/07/2022 Product Code MNQ  Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS082 Date Received03/02/2022 Decision Date04/01/2022 Product Code MNQ  Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS080 Date Received02/17/2022 Decision Date03/16/2022 Product Code MNQ  Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS081 Date Received02/17/2022 Decision Date03/14/2022 Product Code MNQ  Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS079 Date Received02/11/2022 Decision Date03/10/2022 Product Code MNQ  Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No