Philips

FDA Filings

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

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

• Philips Medizin Systeme Boeblingen GmbH
• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
• Martin Pedroza
• PHILIPS MEDICAL SYSTEMS MR FINLAND
• Ron Nolte
• Philips Digital Mammography Sweden AB
• Volcano Corporation by Volcarica S.R.L.
• Tom Brennan
• Philips India Limited
• Philips Healthcare - VSS - Shanghai CDC
• Monique Costanza-Lazzarini
• Philips Electronics Nederland B.V.

FDA Owner/Operator Registration

Similar & Related FDA Registered Companies

• Philips Respironics
• Philips Healthcare
• PHILIPS MEDICAL SYSTEMS
• PHILIPS MEDICAL SYSTEMS GMBH DMC
• Philips Medical Systems Nederland B.V.
• Philips Medical Systems International BV
• Philips Ultrasound LLC
• Philips Healthcare (Suzhou) Co., Ltd.
• Philips Oy
• Philips Medizin Systeme Böblingen GmbH
• Philips Medical Systems DMC GmbH
• Philips Medizin Systeme Boeblingen GmbH
• Philips Ultrasound, Inc.
• Philips India Limited
• Philips Medical Systems Nederlands B.V.
• Philips Medical System Nederland B.V.
• Philips Consumer Lifestyle - Innovation Site Eindhoven
• Philips Image Guided Therapy Corporation
• Philips Healthcare (Suzhou) Co., Lit.
• Philips Medical Systems MR Finland
• Philips Electronics Nederland B.V.
• Philips Healthcare Informatics, Inc.
• Philips Medical Systems Technologies, Ltd.
• Philips Image Guided Therapy Corporation (formerly Intact)5905 Nathan Lane Northplymouth, MN 55442 PMA NumberP190027 Supplement NumberS005 Date Received08/29/2022 Decision Date11/09/2022 Product Code QCT  Advisory Committee Cardiovascular Clinical TrialsNCT02942966 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No
• PHILIPS MEDICAL SYSTEMS, INC.22100 Bothell -everett Hwybothell, WA 98021 PMA NumberP160029 Supplement NumberS017 Date Received07/05/2022 Decision Date07/27/2022 Product Codes NSA MKJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• PHILIPS MEDICAL SYSTEMS, INC.22100 Bothell -everett Hwybothell, WA 98021 PMA NumberP160029 Supplement NumberS016 Date Received05/11/2022 Decision Date06/08/2022 Product Codes MKJ NSA  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Philips Image Guided Therapy Corporation (formerly Intact)5905 Nathan Lane Northplymouth, MN 55442 PMA NumberP190027 Supplement NumberS004 Date Received02/23/2022 Decision Date05/24/2022 Product Code QCT  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Philips Image Guided Therapy Corporation5905 Nathan Lane Northplymouth, MN 55442 PMA NumberP180034 Supplement NumberS007 Date Received02/23/2022 Decision Date05/24/2022 Product Code QCT  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Philips Medical Systems22100 Bothell Everett Hwybothell, WA 98021 PMA NumberP180028 Supplement NumberS012 Date Received02/22/2022 Decision Date03/20/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• PHILIPS MEDICAL SYSTEMS, INC.22100 Bothell -everett Hwybothell, WA 98021 PMA NumberP160029 Supplement NumberS015 Date Received02/22/2022 Decision Date03/20/2022 Product Codes MKJ NSA  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Philips Image Guided Therapy Corporation (formerly Intact)
• PHILIPS MEDICAL SYSTEMS, INC.
• PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
• Philips Consumer Lifestyle B.V.
• Philips Digital Mammography Sweden AB
• PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
• Philips Medical Systems Hsg
• Philips North America LLC
• PHILIPS ORAL HEALTHCARE, LLC
• PHILIPS FRANCE COMMERCIAL

Related Finance Registrations

NCAGE Code	0TBA7	PHILIPS
NCAGE Code	T3498	PHILIPS
CAGE Code	0TBA7	PHILIPS
CAGE Code	T3498	PHILIPS

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091789502	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	FURNITURE	1 PKG
202009152460	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	LOUVER RECT STEPLIGHT SIZE1 REV D	29 CTN
202009141684	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	LOUVER RECT STEPLIGHT SIZE1 REV D	29 CTN
202009114050	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	LOUVER RECT STEPLIGHT SIZE1 REV D	29 CTN
2020090990524	Yantian,China (Mainland) -> Los Angeles, California	LANA NAM TOYS PO NO:IO2000825 HS CODE(S): 950300 THIS SHIPMENT CONTAINS NO WOOD PACKAGING MATERIALS	265 CTN
202009046175	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	LOUVER RECT STEPLIGHT SIZE1 REV D	29 CTN
2020083151788	Yantian,China (Mainland) -> Long Beach, California	LANA NAM TOYS PO NO:IO2000737 PO NO:IO2000825 HS CODE(S): 950300 THIS SHIPMENT CONTAINS NO WOOD PACKAGING MATERIALS	270 CTN
202007155699	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	LOUVER RECT STEPLIGHT SIZE1 REV D	20 CTN