FDA.reportPublic FDA data

PHILIPS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12189501218950Philips North America LLC1N2026-01-013000 Minuteman Rd ANDOVER MA US 01810
25185862518586Philips Ultrasound LLC1N2026-01-011 Echo Dr Reedsville PA US 17084
30192163019216Philips Ultrasound LLC1Y2026-01-0122100 Bothell Everett Hwy BOTHELL WA US 98021
30266301000126901PHILIPS ORAL HEALTHCARE, LLC1N2026-01-0122100 Bothell Everett Highway Bothell WA US 98021
30306771000524572Philips North America LLC1N2026-01-0122100 Bothell Everett Hwy Bothell WA US 98021
96108163002807167Philips Medizin Systeme Boeblingen GmbH1N2026-01-01HEWLETT-PACKARD STRASSE 2 BOEBLINGEN Baden-Wurttemberg DE D 71034
96179783008581796PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.1N2026-01-01ADVANCED TECHNOLOGY CENTER MATAM BUILDING 34 HAIFA IL 3100202
30001266293000126629Philips Electronics Ltd1N2026-01-011875 Buckhorn Gate, 5th Floor Mississauga Ontario CA L4W 5P1
30009765253000976525Philips Medical Systems Nederland B.V.1N2026-01-01High Tech Campus 36 Eindhoven Noord-Brabant NL 5656 AE
30036308063003630806Philips Austria GmbH1N2026-01-01Koningsbergerstrasse 11 Klagenfurt Karnten AT 9020
30036871893003687189Philips Goldway (Shenzhen) Industrial Inc.1N2026-01-01No.2 Keji North 3rd Road Nan Shan District SHENZHEN Guangdong CN 518057
30037682513003768251Philips Medical Systems DMC GmbH1N2026-01-01Roentgenstrasse 24 HAMBURG DE 22335
30066483203006648320Philips North America LLC1N2026-01-01222 Jacobs Street Cambridge MA US 02141
30091815613009181561Philips Personal Health, a division of Philips North America LLC1Y2026-01-011055 Washington Blvd. 9th Floor, Suite 950 Stamford CT US 06901
30103592223010359222Philips Consumer Lifestyle B.V.1N2026-01-01Tussendiepen 4 Drachten Fryslan NL 9206AD
30120277703012027770Philips (China) Investment Co., Ltd. Philips Healthcare - Shanghai CDC1N2026-01-01Building A1, #718 Lingshi Road JingAn District SHANGHAI CN 200072
30125281603012528160Philips North America LLC1N2026-01-011001 Murry Ridge Lane STE A Murrysville PA US 15668
30126077783012607778Philips North America LLC1N2026-01-0115100 Woodinville-Redmond Road NE Bldg A, Suite 300 Woodinville WA US 98072
30145417003014541700Philips Medical Systems Ltda1N2026-01-01Avenida Otto Selgado, 250 Varginha Minas Gerais BR CEP 37066
30145558053014555805Philips Medical Systems P.R. Inc.1Y2026-01-01Suite 512 Montehiedra Office Center 9615 Ave Los Romeros San Juan PR US 00926
30162573493016257349Philips Image Guided Therapy Corporation1N2026-01-015905 Nathan Lane North Plymouth MN US 55442
30166181433016618143Philips North America LLC1Y2026-01-01222 Jacobs Street Cambridge MA US 02141
30167014043016701404Philips North America LLC1N2026-01-011003 Corporate Lane STE B Export PA US 15632
30178949003017894900Philips Ultrasound LLC1N2026-01-01222 Jacobs Street Cambridge MA US 02141
30180048993018004899Philips Medical Systems (Cleveland), Inc.1N2026-01-013630 SW 47th Avenue Gainesville FL US 32608

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00884838072558Invivo - Fully Automatic Biopsy Gun+1(877)468-4861dynasupport@invivocorp.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2832491793685059P960042SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATHMFA1997-12-09
2367451592089172P230021Duo Venous Stent SystemQAN2023-12-26
12571177448740P180028HeartStart FRx DefibrillatorMKJ2020-05-11
2228091177448740P180028HeartStart FRx DefibrillatorMKJ2020-05-11
2832491177448740P180028HeartStart FRx DefibrillatorMKJ2020-05-11
2367452044557099P160049STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONONU2017-07-26
12571147793398P160029HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)NSA2019-06-06
2228091147793398P160029HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)NSA2019-06-06
2832491147793398P160029HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)NSA2019-06-06
12571444070357P160028Philips HeartStart FR3 DefibrillatorMKJ2020-05-11
2228091444070357P160028Philips HeartStart FR3 DefibrillatorMKJ2020-05-11
2832491444070357P160028Philips HeartStart FR3 DefibrillatorMKJ2020-05-11
2832491004592557P050018ANGIOSCULPT SCORING BALLOON CATHETERNWX2007-01-08
12311771960806K994188MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5CBQ2000-05-19
12351771960806K994188MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5CBQ2000-05-19
12581069807376K993946PEGASYS ULTRALLZ2000-03-09
2881001130667519K993923ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEMMUJ2000-04-07
2832491929009126K993819QWH-300 WRIST ARRAY COILMOS1999-12-03
2832491209117672K993776OBC-300 BREAST ARRAY COILMOS1999-12-03
2832492052297929K993477HRW WRIST ARRAY COILMOS1999-11-01
12311651853032K993383HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.BDSI2000-02-03
12351651853032K993383HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.BDSI2000-02-03
2491751651853032K993383HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.BDSI2000-02-03
2832491651853032K993383HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.BDSI2000-02-03
2832491144147427K993279QSC-085 SHOULDER ARRAY COILMOS1999-10-15
2832491497022755K992969RESPIRONICS TOTAL FACE MASKBZD1999-11-10
12311527164104K992674HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027AMHX1999-11-08
12351527164104K992674HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027AMHX1999-11-08
2832491527164104K992674HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027AMHX1999-11-08
12311605326894K992595HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT MEASUREMENT, HP VIRIDIA CMS 24/26, REV K WITHMHX1999-12-08
12351605326894K992595HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT MEASUREMENT, HP VIRIDIA CMS 24/26, REV K WITHMHX1999-12-08
12581036697622K992335BEACON-P, MODEL 211059KPS1999-10-07
12311320908583K992273HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR M3000A/M3046A/M3016A,REL BMHX2000-01-28
12351320908583K992273HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR M3000A/M3046A/M3016A,REL BMHX2000-01-28
12311602486209K991773HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PDSI1999-06-07
12351602486209K991773HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PDSI1999-06-07
2832492021081260K991725SIDESTREAM NEBULIZERCAF1999-07-30
12271177303896K991671HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEMIYO1999-06-18
2832491177303896K991671HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEMIYO1999-06-18
3006281177303896K991671HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEMIYO1999-06-18
2832491296732275K991648REUSABLE CONTOUR II NASAL MASKBZD1999-05-28
12581961019751K991607VANTAGE 2.5KPS1999-07-26
2832491463302134K991366DAUM MRI/CONVENTIONAL BIOPSY KITKNW1999-06-25
2832491705899043K991105ECG ELECTRODE (VARIOUS)DRX1999-11-26
12311080299950K990972HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE TDSI1999-04-19
12351080299950K990972HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE TDSI1999-04-19
2832491072683546K990713SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTERDRB1999-10-22
12311042028767K990476HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, MODEL REV. K WITH EASI-ECG OPTIONMHX1999-07-22
12351042028767K990476HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, MODEL REV. K WITH EASI-ECG OPTIONMHX1999-07-22
12271326600785K990339SONOS 5500 IMAGING SYSTEM M2424A VERSION B.OIYN1999-02-18
2832491326600785K990339SONOS 5500 IMAGING SYSTEM M2424A VERSION B.OIYN1999-02-18
3006281326600785K990339SONOS 5500 IMAGING SYSTEM M2424A VERSION B.OIYN1999-02-18
12351853071026K990199SMARTRECORDER, MODEL 2500MNR1999-04-19
12311824423863K990125HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. KDSI1999-01-29
12351824423863K990125HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. KDSI1999-01-29
12571794526719K984286HEARTSTREAM ELECTRODE ADAPTERMKJ1998-12-17
2228091794526719K984286HEARTSTREAM ELECTRODE ADAPTERMKJ1998-12-17
2832491794526719K984286HEARTSTREAM ELECTRODE ADAPTERMKJ1998-12-17
12581939847733K983948BEACON, MODEL 211060KPS1999-04-16
2832491216971191K983533ACTIWATCHGWQ1999-03-23
2832491456544812K983109MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANYMOS1998-10-06
12371128069375K983069PHILIPS DUO DIAGNOSTOWB1998-11-02
2832491128069375K983069PHILIPS DUO DIAGNOSTOWB1998-11-02
12581944720132K982911FORTEKPS1998-11-16
12371102766344K982795PHILIPS BUCKY VISIONMQB1998-11-24
2832491102766344K982795PHILIPS BUCKY VISIONMQB1998-11-24
12371221684535K982795PHILIPS BUCKY VISIONMQB1998-11-24
2832491221684535K982795PHILIPS BUCKY VISIONMQB1998-11-24
12351105409019K982619HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02CCL1998-08-12
2832491322818088K982454BIPAP VISION VENTILATORY SUPPORTMNT1998-11-03
2832491786226061K982293PRESSURE TRANSDUCER AIRFLOW SENSORMNR1998-07-13
12351087570410K982283WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WHBYE1999-03-09
2832491087570410K982283WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WHBYE1999-03-09
12351277158245K981737K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60MKJ1998-12-09
12571277158245K981737K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60MKJ1998-12-09
12311672284237K981576MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046AMHX1998-07-17
12351672284237K981576MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046AMHX1998-07-17
12581176610904K981291VANTAGE 3.0 INSYNCHKPS1998-06-29
12581459698759K9808673D-MSPECTKPS1998-06-04
12581287294020K980715AUTOQUANT QUANTITATIVE PERFUSION SPECT (QPS) & QUANTITATIVE GATED SPECT (QGS)KPS1998-05-06
12351860199553K980327MICROSTREAM FILTERLINE ICUCCK1998-04-16
2491751860199553K980327MICROSTREAM FILTERLINE ICUCCK1998-04-16
2832491860199553K980327MICROSTREAM FILTERLINE ICUCCK1998-04-16
12352007850430K980325MICROSTREAM NASAL CANNULA FILTERLINECCK1998-04-16
2491752007850430K980325MICROSTREAM NASAL CANNULA FILTERLINECCK1998-04-16
12351463050292K980324MICROSTREAM FILLERLINE OR/EMSCCK1998-04-16
2491751463050292K980324MICROSTREAM FILLERLINE OR/EMSCCK1998-04-16
2832491463050292K980324MICROSTREAM FILLERLINE OR/EMSCCK1998-04-16
2832491721305778K98007456 SERIES AEROSOL GENERATORCAF1998-06-12
12351851409731K980045CENTURION CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEMDSI1998-11-16
2832491078556459K974631DAUM NEUROBIOPSY NEEDLEKNW1998-03-09
2832491203409319K974576DAUM BIOPSYGUNKNW1998-03-06
2832491169685159K974575DAUM ASPIRATIONBIOPSY NEEDLEKNW1998-03-06
2832491692845957K974574DAUM NEUROPUNCTURE NEEDLEKNW1998-03-06
12581090972624K974474PEGASYS INTOUCHLLZ1998-02-24
12351374506456K974087MODEL M1792A THROMBOLYTIC PREDICTIVE INSTRUMENTLOS1998-06-15
12311735508621K973437HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULESDPS1997-12-03
12351735508621K973437HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULESDPS1997-12-03
2491751735508621K973437HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULESDPS1997-12-03
2832491735508621K973437HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULESDPS1997-12-03
12581939434747K973396QUEST PET IMAGING SYSTEMKPS1998-01-21
12581473595918K973233IMAGE FUSION AND REVIEW SYSTEMKPS1997-11-25
12571982708844K972418HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX)MKJ1997-09-25
2228091982708844K972418HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX)MKJ1997-09-25
2832491982708844K972418HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX)MKJ1997-09-25
12581188155278K971980MCD-ACKPS1997-10-23
12311595911040K971910MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A)DSI1998-03-23
12351595911040K971910MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A)DSI1998-03-23
3204601595911040K971910MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A)DSI1998-03-23
12581786917280K971878VANTAGE 2.1 EXSPECTKPS1997-08-08
2832491870862141K970868MODEL HNC NEUROVASCULAR ARRAY COILMOS1997-06-06
12371298466081K970640PHILIPS EASY DIAGNOSTIXR1997-03-21
2832491298466081K970640PHILIPS EASY DIAGNOSTIXR1997-03-21
12351166426109K970629TANGO NON-INVASIVE BLOOD PRESSURE MONITORDXN1998-01-02
2832491629689683K970037TARGOGRIDLNH1997-03-12
12311383010392K965160HP ORVUE INTRA-OP (M2510A)BSZ1997-09-11
12581833528571K964712PRISM XPVT SYSTEM (210823)KPS1997-02-21
2832491021958305K964668MODELS EXL AND EXS EXTREMITY COIL SETMOS1997-02-18
2832491932950946K964653OASIS HUMIDIFIERBTT1997-02-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN1802026-03-27
MHX1732026-02-06
MOS762021-12-23
DQA662017-07-27
LLZ642025-10-02
KPS532021-08-06
CCK442019-03-22
MWI432022-01-14
JAK422026-03-27
DRX412009-08-21
DSI402015-07-17
MKJ392015-01-23
HGM382024-07-02
BZD362024-07-31
DPS252024-12-17
CBK252020-05-04
MSX212026-03-30
MQB212020-09-30
LNH152019-06-04
DXN142012-02-14
CAF132017-11-02
DXQ132015-10-27
QIH122025-03-06
DXJ122021-09-30
DRS122006-09-19
DSJ112019-10-27
IYO112017-12-13
DQK102012-07-18
OBJ92020-09-02
BZQ92014-03-26
ITX92009-07-17
MNR92009-06-26
DSA82025-01-17
MUE82013-12-13
MNS82012-02-01
BSZ82008-12-18
DRT82005-01-10
FLL82004-04-22
KPR72024-06-13
JAA72024-01-11

PMA#

Tack Endovascular System (4F, 1.5-4.5mm)

2022-11-09

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 TrialsNCT...

Tack Endovascular System (4F)

2022-05-24

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 Typenor...

Tack Endovascular System (6F)

2022-05-24

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 ...

HeartStart OnSite Home Defibrillator

2022-03-20

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...

HeartStart FRx Defibrillator

2022-03-20

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 Proc...

62 records. Showing 1-40. Next

PMN#

Spectral CT

2025-05-16

Philips Medical Systems Technologies , Ltd.

ROCC Console

2024-10-24

Philips Medical Systems Nederland B.V.

Zenition 90

2024-05-22

Philips Medical Systems Nederlands B.V.

CT 5300

2024-05-03

Philips Healthcare (Suzhou) Co., Ltd.

Zenition 30

2024-02-16

Philips Medical Systems Nederland B.V.

200 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next