Physio Control

FDA Filings

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

Physio Control holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Kathryn Janecke

FDA Owner/Operator Registration

Similar & Related FDA Registered Companies

• Physio-Control Maastricht, Inc.
• Physio-Control, Inc.
• PHYSIO-CONTROL CORP.
• Physio-Control, Inc11811 Willows Road Neredmond, WA 98052 PMA NumberP170018 Supplement NumberS015 Date Received10/13/2022 Decision Date01/10/2023 Product Code MKJ  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Physio-Control. Inc.11811 Willows Road Neredmond, WA 98052 PMA NumberP160026 Supplement NumberS037 Date Received12/22/2022 Decision Date01/04/2023 Product Code MKJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Physio-Control. Inc.11811 Willows Road Neredmond, WA 98052 PMA NumberP160026 Supplement NumberS036 Date Received12/06/2022 Decision Date12/12/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Physio-Control. Inc.11811 Willows Road Neredmond, WA 98052 PMA NumberP160026 Supplement NumberS035 Date Received10/31/2022 Decision Date11/10/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Physio-Control. Inc.11811 Willows Road Neredmond, WA 98052 PMA NumberP160026 Supplement NumberS034 Date Received10/14/2022 Decision Date10/27/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Physio-Control, Inc11811 Willows Road Neredmond, WA 98052 PMA NumberP170018 Supplement NumberS014 Date Received07/27/2022 Decision Date09/27/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Physio-Control. Inc.11811 Willows Road Neredmond, WA 98052 PMA NumberP160026 Supplement NumberS033 Date Received07/22/2022 Decision Date08/16/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Physio-Control. Inc.11811 Willows Road Neredmond, WA 98052 PMA NumberP160026 Supplement NumberS031 Date Received05/13/2022 Decision Date07/28/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Physio-Control. Inc.11811 Willows Road Neredmond, WA 98052 PMA NumberP160026 Supplement NumberS032 Date Received07/08/2022 Decision Date07/28/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Physio-Control. Inc.11811 Willows Rd. Neredmond, WA 98052 PMA NumberP160012 Supplement NumberS006 Date Received05/16/2022 Decision Date07/20/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	M0434	PHYSIO CONTROL
NCAGE Code	FA2B7	PHYSIO CONTROL
NCAGE Code	5J401	PHYSIO-CONTROL
CAGE Code	FA2B7	PHYSIO CONTROL
CAGE Code	5J401	PHYSIO-CONTROL
CAGE Code	M0434	PHYSIO CONTROL

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020012727424	Hong Kong,Hong Kong -> Seattle, Washington	BASE REDI - CHARGE BATTERY CHARGER ADAPTER REDI CHARGE BATTERY CHARGER LP15	1200 CTN
2020012727424	Hong Kong,Hong Kong -> Seattle, Washington	BASE REDI - CHARGE BATTERY CHARGER ADAPTER REDI CHARGE BATTERY CHARGER LP15	1200 CTN
2020012727424	Hong Kong,Hong Kong -> Seattle, Washington	BASE REDI - CHARGE BATTERY CHARGER ADAPTER REDI CHARGE BATTERY CHARGER LP15	1200 CTN
2019100527547	Yantian,China (Mainland) -> Tacoma, Washington	ADAPTER, POWER, AC TO DC, ENHANCED, LP15	155 CTN
2019020811471	Yantian,China (Mainland) -> Tacoma, Washington	LP15 DC-DC POWER ADAPTER	162 CTN
201811071377	Le Havre,France -> New York/Newark Area, Newark, New Jersey	------------ TRHU3048666 DESCRIPTION--------- 1 PACKAGE 9 KGM BATTERY 1 CARTON CL9 UN3090 IMCO NUMBER: 9	1 PCS
2018102535469	Le Havre,France -> New York/Newark Area, Newark, New Jersey	------------ TRHU2851436 DESCRIPTION--------- 1 CARTON 3 KGM 0.005 MTQ PILES LITHIUM 1 CARTON PSN: PERFUMERY PRODUCTS	1 PCS
2018100976197	Le Havre,France -> New York/Newark Area, Newark, New Jersey	------------ TRHU2851436 DESCRIPTION--------- 1 CARTON 3 KGM 0.005 MTQ PILES LITHIUM 1 CARTON PSN: PERFUMERY PRODUCTS	1 PCS
2018082179861	Le Havre,France -> New York/Newark Area, Newark, New Jersey	------------ TRHU3048666 DESCRIPTION--------- 1 PACKAGE 9 KGM BATTERY 1 CARTON CL9 UN3090 IMCO NUMBER: 9	1 PCS
2018071216272	Sines,Portugal -> Seattle, Washington	ROTAID PLUS ALARM TRANSPARENT GREEN PC 332517 4-001 ROTAID PLUS ALARM TRANSPARENT YELLOW PC 3325174-003 ROTAID SOLID PLUS ALARM TRANSPAR ENT GREEN PC 3325174-011 ROTAID SOLID PLUS AL ARM TRANSPARENT YELLOW PC 3325174- 013 ROTAID PLUS ALARM TRANSPARENT WHITE PC 3325174-000 ROTAID PLUS ALARM TRANSPARENT RED PC 3325174-	17 PKG