Philips Medical Systems Inc

FDA Filings

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

FDA Registration(s)

FDA Filings

Device Company	Device	Date
PMA P160029S013 PHILIPS MEDICAL SYSTEMS, INC.	HeartStart OnSite Defibrillator, HeartStart Home Defibrillator, HS1 SMART Pads, Adult, HS1 SMART Pads, Infant/Child	2021-08-10
PMA P160029S012 PHILIPS MEDICAL SYSTEMS, INC.	HeartStart OnSite Defibrillator and HeartStart Home Defibrillator	2021-06-15
PMA P160028S004 PHILIPS MEDICAL SYSTEMS, INC.	HeartStart FR3 Defibrillator	2021-06-15
PMA P160029S011 PHILIPS MEDICAL SYSTEMS, INC.	HeartStart Home Defibrillator and HeartStart Onsite Defibrillator	2021-04-19
PMA P160029S010 PHILIPS MEDICAL SYSTEMS, INC.	HeartStart OnSite Defibrillator and HeartStart Home Defibrillator	2021-03-10
PMA P160029S009 PHILIPS MEDICAL SYSTEMS, INC.	HeartStart Home Defibrillator and HeartStart OnSite Defibrillator	2021-02-12
PMA P160029S007 PHILIPS MEDICAL SYSTEMS, INC.	HeartStart OnSite Defibrillator, and HeartStart Home Defibrillator	2020-12-16
PMA P160028S003 PHILIPS MEDICAL SYSTEMS, INC.	HeartStart FR3 Defibrillator	2020-12-16
PMA P160029S006 PHILIPS MEDICAL SYSTEMS, INC.	HeartStart OnSite Defibrillator and HeartStart Home Defibrillator	2020-08-22
PMA P160029S005 PHILIPS MEDICAL SYSTEMS, INC.	HeartStart Home Defibrillator and HeartStart Onsite Defibrillator	2020-08-03
PMA P160028S001 PHILIPS MEDICAL SYSTEMS, INC.	HeartStart FR3 Defibrillator	2020-08-03
PMA P160029S004 PHILIPS MEDICAL SYSTEMS, INC.	HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)	2020-07-16
PMA P160028 PHILIPS MEDICAL SYSTEMS, INC.	Philips HeartStart FR3 Defibrillator	2020-05-11
PMA P160029S002 PHILIPS MEDICAL SYSTEMS, INC.	HeartStart OnSite Defibrillator and HeartStart Home Defibrillator	2019-11-26
PMA P160029 PHILIPS MEDICAL SYSTEMS, INC.	HeartStart OnSite Defibrillator (Model M6066A) and HeartStart Home Defibrillator (Model M5068A)	2019-06-06
PMN K093355 PHILIPS MEDICAL SYSTEMS, INC.	PCR ELEVA 1.2	2010-01-08
PMN K090808 PHILIPS MEDICAL SYSTEMS, INC.	PINNACLE3 SMARTARC	2009-04-03
PMN K071391 PHILIPS MEDICAL SYSTEMS, INC.	PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521	2007-09-07
PMN K063783 PHILIPS MEDICAL SYSTEMS, INC.	PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A	2007-04-27
PMN K041741 PHILIPS MEDICAL SYSTEMS, INC.	M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN	2004-07-21
PMN K040955 PHILIPS MEDICAL SYSTEMS, INC.	M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN	2004-05-12
PMN K040404 PHILIPS MEDICAL SYSTEMS, INC.	HEARTSTART MRX, MODEL M3535A	2004-05-04
PMN K040357 PHILIPS MEDICAL SYSTEMS, INC.	M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II	2004-03-03
PMN K032979 PHILIPS MEDICAL SYSTEMS, INC.	PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T	2004-02-20
PMN K033715 PHILIPS MEDICAL SYSTEMS, INC.	PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER	2004-02-13
PMN K033662 PHILIPS MEDICAL SYSTEMS, INC.	SYNERGY SPINE ARRAY COIL	2004-02-02
PMN K033326 PHILIPS MEDICAL SYSTEMS, INC.	PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM	2003-10-29
PMN K032046 PHILIPS MEDICAL SYSTEMS, INC.	PHILLIPS OMNIDIAGNOST ELEVA	2003-07-17
PMN K031403 PHILIPS MEDICAL SYSTEMS, INC.	M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.1	2003-05-30
PMN K030038 PHILIPS MEDICAL SYSTEMS, INC.	PHILIPS MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS WITH PORTAL TECHNOLOGY AND M3185 OPT C41 WIRELESS BEDSIDE ADAPTR	2003-03-12
PMN K023931 PHILIPS MEDICAL SYSTEMS, INC.	PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A	2003-02-24
PMN K024042 PHILIPS MEDICAL SYSTEMS, INC.	PANORAMA ENHANCEMENTS	2003-02-04
PMN K013644 PHILIPS MEDICAL SYSTEMS, INC.	ACQPLAN 5.0	2002-09-12
PMN K020708 PHILIPS MEDICAL SYSTEMS, INC.	PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES	2002-04-25
PMN K014261 PHILIPS MEDICAL SYSTEMS, INC.	ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.0	2002-02-12
PMN K014181 PHILIPS MEDICAL SYSTEMS, INC.	M2376A DEVICELINK SYSTEM, MODEL M2376A	2002-01-15
PMN K013427 PHILIPS MEDICAL SYSTEMS, INC.	MODIFICATION TO:PHILIPS M3000A/M3046A COMPACT PORTABLE PATIENT MONITOR, MODELS PHILIPS M3000A/M3046A	2001-11-29
PMN K013199 PHILIPS MEDICAL SYSTEMS, INC.	PHILIPS COMPONENT COMPACT MONITOR,MODEL M1275B, PHILIPS COMPENENT RACK, MODEL M1276B	2001-11-28
PMN K010762 PHILIPS MEDICAL SYSTEMS, INC.	PHILIPS BV LIBRA	2001-04-02
PMN K010435 PHILIPS MEDICAL SYSTEMS, INC.	PHILIPS BV PULSERA/ENDURA	2001-03-12
PMN K994210 PHILIPS MEDICAL SYSTEMS, INC.	INTURIS SUITE	2000-02-04
PMN K990455 PHILIPS MEDICAL SYSTEMS, INC.	PHILIPS EASY VISION FAMILY WORKSTATION LEGS OPTION	1999-05-12
PMA P840063S006 PHILIPS MEDICAL SYSTEMS, INC.	GYROSCAN(TM)	1988-05-05
PMA P840063S007 PHILIPS MEDICAL SYSTEMS, INC.	GYROSCAN(TM)	1988-05-02
PMA P840063S005 PHILIPS MEDICAL SYSTEMS, INC.	GYROSCAN(TM)	1987-08-11
PMA P840063S004 PHILIPS MEDICAL SYSTEMS, INC.	GYROSCAN(TM)	1987-07-13
PMA P840063S003 PHILIPS MEDICAL SYSTEMS, INC.	GYROSCAN(TM)	1987-04-08
PMA P840063S001 PHILIPS MEDICAL SYSTEMS, INC.	GYROSCAN(TM)	1987-03-03
PMA P840063S002 PHILIPS MEDICAL SYSTEMS, INC.	GYROSCAN(TM)	1987-01-30

Similar & Related FDA Registered Companies

Philips Medical Systems (Cleveland) Inc.
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
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 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

Related Finance Registrations

NCAGE Code	1F108	PHILIPS MEDICAL SYSTEMS INC
NCAGE Code	1HL54	PHILIPS MEDICAL SYSTEMS INC
NCAGE Code	1M456	PHILIPS MEDICAL SYSTEMS INC
NCAGE Code	2S168	PHILIPS MEDICAL SYSTEMS INC
NCAGE Code	4J370	PHILIPS MEDICAL SYSTEMS INC
NCAGE Code	4X121	PHILIPS MEDICAL SYSTEMS INC
NCAGE Code	9T771	PHILIPS MEDICAL SYSTEMS INC
NCAGE Code	7U145	PHILIPS MEDICAL SYSTEMS INC
NCAGE Code	7K297	PHILIPS MEDICAL SYSTEMS INC
CAGE Code	1F108	PHILIPS MEDICAL SYSTEMS INC
CAGE Code	1HL54	PHILIPS MEDICAL SYSTEMS INC
CAGE Code	1M456	PHILIPS MEDICAL SYSTEMS INC
CAGE Code	2S168	PHILIPS MEDICAL SYSTEMS INC
CAGE Code	4J370	PHILIPS MEDICAL SYSTEMS INC
CAGE Code	7U145	PHILIPS MEDICAL SYSTEMS INC
CAGE Code	9T771	PHILIPS MEDICAL SYSTEMS INC
CAGE Code	4X121	PHILIPS MEDICAL SYSTEMS INC
CAGE Code	7K297	PHILIPS MEDICAL SYSTEMS INC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019021319064	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	SYNCHCESS SLIPRING SHACKLE	1 PKG
201804174381	Sydney,Australia -> Charleston, South Carolina	CRATE	1 PKG
201804175792	Sydney,Australia -> Charleston, South Carolina	DENTAL APPARATUS	2 PKG
201804175792	Sydney,Australia -> Charleston, South Carolina	DENTAL APPARATUS	2 PKG
201804126157	Sydney,Australia -> Philadelphia, Pennsylvania	CRATE	1 PKG
201804129687	Sydney,Australia -> Philadelphia, Pennsylvania	DENTAL APPARATUS	2 PKG
201804129687	Sydney,Australia -> Philadelphia, Pennsylvania	DENTAL APPARATUS	2 PKG