Kestra Medical Technologies Inc

FDA Filings

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

FDA Filings

Device Company	Device	Date
GUDID 00840241600382 Kestra Medical Technologies, Inc.	Kestra Provided Device Patient Application 80740-001	2024-09-26
GUDID 00840241600344 Kestra Medical Technologies, Inc.	ASSURE Assist Service 80739-001	2024-09-26
GUDID 00840241600337 Kestra Medical Technologies, Inc.	System Cable 80500-003	2024-09-26
GUDID 00840241600320 Kestra Medical Technologies, Inc.	Battery 80499-003	2024-09-26
GUDID 00840241600313 Kestra Medical Technologies, Inc.	ASSURE Wearable ECG 80553-001	2024-09-26
GUDID 00840241600238 Kestra Medical Technologies, Inc.	ASSURE WCD System 80014-002	2023-07-04
GUDID 00840241600283 Kestra Medical Technologies, Inc.	ASSURE Patient Application 80601-001	2023-03-21
GUDID 00840241600306 Kestra Medical Technologies, Inc.	CareStation Server 80605-004	2023-03-20
GUDID 00840241600290 Kestra Medical Technologies, Inc.	CareStation Server 80605-003	2023-02-20
GUDID 00840241600276 Kestra Medical Technologies, Inc.	CareStation Server 80433-003	2023-02-20
GUDID 00840241600252 Kestra Medical Technologies, Inc.	ASSURE Patient Application 80429-003	2022-07-04
GUDID 00840241600269 Kestra Medical Technologies, Inc.	CareStation Server 80433-002	2022-06-21
PMA P200037S003 Kestra Medical Technologies, Inc.	ASSURE Wearable Cardioverter Defibrillator (WCD) System	2021-12-17
GUDID 00840241600207 Kestra Medical Technologies, Inc.	ASSURE, Carry Pack 3326502-003	2021-11-23
GUDID 00840241600191 Kestra Medical Technologies, Inc.	ASSURE, Tablet 80041-001	2021-11-23
GUDID 00840241600184 Kestra Medical Technologies, Inc.	ASSURE, Garment, Style B, Size 7 80016-007	2021-11-23
GUDID 00840241600177 Kestra Medical Technologies, Inc.	ASSURE, Garment, Style B, Size 6 80016-006	2021-11-23
GUDID 00840241600160 Kestra Medical Technologies, Inc.	ASSURE, Garment, Style B, Size 5 80016-005	2021-11-23
GUDID 00840241600153 Kestra Medical Technologies, Inc.	ASSURE, Garment, Style B, Size 4 80016-004	2021-11-23
GUDID 00840241600146 Kestra Medical Technologies, Inc.	ASSURE, Garment, Style B, Size 3 80016-003	2021-11-23
GUDID 00840241600139 Kestra Medical Technologies, Inc.	ASSURE, Garment, Style B, Size 2 80016-002	2021-11-23
GUDID 00840241600122 Kestra Medical Technologies, Inc.	ASSURE, Garment, Style B, Size 1 80016-001	2021-11-23
GUDID 00840241600115 Kestra Medical Technologies, Inc.	ASSURE, Garment, Style A, Size 7 80015-007	2021-11-23
GUDID 00840241600108 Kestra Medical Technologies, Inc.	ASSURE, Garment, Style A, Size 6 80015-006	2021-11-23
GUDID 00840241600092 Kestra Medical Technologies, Inc.	ASSURE, Garment, Style A, Size 5 80015-005	2021-11-23
GUDID 00840241600085 Kestra Medical Technologies, Inc.	ASSURE, Garment, Style A, Size 4 80015-004	2021-11-23
GUDID 00840241600078 Kestra Medical Technologies, Inc.	ASSURE, Garment, Style A, Size 3 80015-003	2021-11-23
GUDID 00840241600061 Kestra Medical Technologies, Inc.	ASSURE, Garment, Style A, Size 2 80015-002	2021-11-23
GUDID 00840241600054 Kestra Medical Technologies, Inc.	ASSURE, Garment, Style A, Size 1 80015-001	2021-11-23
GUDID 00840241600047 Kestra Medical Technologies, Inc.	ASSURE WCD System 80014-001	2021-11-23
GUDID 00840241600030 Kestra Medical Technologies, Inc.	ASSURE, Monitor 80008-003	2021-11-23
GUDID 00840241600023 Kestra Medical Technologies, Inc.	ASSURE, Therapy Cable 80004-003	2021-11-23
GUDID 00840241600016 Kestra Medical Technologies, Inc.	ASSURE, Charger 3326633-004	2021-11-23
GUDID 00840241600009 Kestra Medical Technologies, Inc.	ASSURE, Battery 3322882-005	2021-11-23
PMA P200037S001 Kestra Medical Technologies, Inc.	ASSURE Wearable Cardioverter Defibrillator (WCD) System	2021-11-19
GUDID 00840241600214 Kestra Medical Technologies, Inc.	ASSURE Patient Application 80315-005	2021-10-08
PMA P200037 Kestra Medical Technologies, Inc.	ASSURE Wearable Cardioverter Defibrillator (WCD) System	2021-07-27

Similar & Related FDA Registered Companies

• Kestra Medical Technologies, Inc.3933 Lake Washington Boulevard, N.e.suite 200kirkland, WA 98033 PMA NumberP200037 Supplement NumberS006 Date Received12/12/2022 Decision Date01/10/2023 Product Code MVK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Kestra Medical Technologies, Inc.3933 Lake Washington Boulevard, N.e.suite 200kirkland, WA 98033 PMA NumberP200037 Supplement NumberS005 Date Received09/28/2022 Decision Date10/27/2022 Product Code MVK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Kestra Medical Technologies, Inc.3933 Lake Washington Boulevard, N.e.suite 200kirkland, WA 98033 PMA NumberP200037 Supplement NumberS004 Date Received06/02/2022 Decision Date10/25/2022 Product Code MVK  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No