FDA.reportPublic FDA data

PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.

Matched from indexed company URL: Philips Medical Systems

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96179783008581796PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.1N2026-01-01ADVANCED TECHNOLOGY CENTER MATAM BUILDING 34 HAIFA IL 3100202
30009765253000976525Philips Medical Systems Nederland B.V.1N2026-01-01High Tech Campus 36 Eindhoven Noord-Brabant NL 5656 AE
30037682513003768251Philips Medical Systems DMC GmbH1N2026-01-01Roentgenstrasse 24 HAMBURG DE 22335
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
30180048993018004899Philips Medical Systems (Cleveland), Inc.1N2026-01-013630 SW 47th Avenue Gainesville FL US 32608
30421758413042175841PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.1N2026-01-01VEENPLUIS 6 Best Noord-Brabant NL 5684 PC
19378501937850Philips Medical Systems1N2020-04-252039 Concourse Dr Saint Louis MO US 63146
96801943002807913PHILIPS MEDICAL SYSTEMS MR FINLAND1N2020-04-25AYRITIE 4 VANTAA Etela-Suomen laani FI 01510
30040223683004022368Philips Medical Systems (Cleveland), Inc.1N2020-04-255520 Nobel Dr FITCHBURG WI US 53711
30154428593015442859Philips Medical Systems (Cleveland) Inc.1N2020-04-25100 Park Avenue Suite 300 Orange Village OH US 44122

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
00884838013407ECG Electrodes - MX40 Patient Cable consists of 5-wire ECG lead set with integrated 8-pin SpO2 connector cable. Grabber leads, AAMI color coded (colored lead wires). Reusable. Cable length = 85 cm (33.5 .) 1 Sales unit= 1 cable.+1(999)999-9999xx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
12581069807376K993946PEGASYS ULTRALLZ2000-03-09
2426741069807376K993946PEGASYS ULTRALLZ2000-03-09
12461130667519K993923ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEMMUJ2000-04-07
2881001130667519K993923ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEMMUJ2000-04-07
12581036697622K992335BEACON-P, MODEL 211059KPS1999-10-07
2426741036697622K992335BEACON-P, MODEL 211059KPS1999-10-07
2426742010696512K992317AUTOSPECT PLUS WITH INSTILL MOTION CORRECTIONKPS1999-10-01
2426741993655324K992078VANTAGE EXSPECT IIKPS1999-09-01
12581961019751K991607VANTAGE 2.5KPS1999-07-26
2426741961019751K991607VANTAGE 2.5KPS1999-07-26
12581939847733K983948BEACON, MODEL 211060KPS1999-04-16
2426741939847733K983948BEACON, MODEL 211060KPS1999-04-16
12371128069375K983069PHILIPS DUO DIAGNOSTOWB1998-11-02
12581944720132K982911FORTEKPS1998-11-16
2426741944720132K982911FORTEKPS1998-11-16
12371102766344K982795PHILIPS BUCKY VISIONMQB1998-11-24
12371221684535K982795PHILIPS BUCKY VISIONMQB1998-11-24
12581176610904K981291VANTAGE 3.0 INSYNCHKPS1998-06-29
2426741176610904K981291VANTAGE 3.0 INSYNCHKPS1998-06-29
12581459698759K9808673D-MSPECTKPS1998-06-04
2426741459698759K9808673D-MSPECTKPS1998-06-04
12581287294020K980715AUTOQUANT QUANTITATIVE PERFUSION SPECT (QPS) & QUANTITATIVE GATED SPECT (QGS)KPS1998-05-06
2426741287294020K980715AUTOQUANT QUANTITATIVE PERFUSION SPECT (QPS) & QUANTITATIVE GATED SPECT (QGS)KPS1998-05-06
2426741478104657K974513PINPOINTJAK1998-05-20
12581090972624K974474PEGASYS INTOUCHLLZ1998-02-24
2426741090972624K974474PEGASYS INTOUCHLLZ1998-02-24
12581939434747K973396QUEST PET IMAGING SYSTEMKPS1998-01-21
2426741939434747K973396QUEST PET IMAGING SYSTEMKPS1998-01-21
12581473595918K973233IMAGE FUSION AND REVIEW SYSTEMKPS1997-11-25
2426741473595918K973233IMAGE FUSION AND REVIEW SYSTEMKPS1997-11-25
12581188155278K971980MCD-ACKPS1997-10-23
2426741188155278K971980MCD-ACKPS1997-10-23
3204601595911040K971910MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A)DSI1998-03-23
12581786917280K971878VANTAGE 2.1 EXSPECTKPS1997-08-08
2426741786917280K971878VANTAGE 2.1 EXSPECTKPS1997-08-08
12371298466081K970640PHILIPS EASY DIAGNOSTIXR1997-03-21
12581833528571K964712PRISM XPVT SYSTEM (210823)KPS1997-02-21
2426741833528571K964712PRISM XPVT SYSTEM (210823)KPS1997-02-21
12371828905146K964124PHILIPS COMPUTED RADIOGRAPHYLLZ1996-12-18
2426741107697713K962010EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMSLLZ1997-03-21
2426741949209068K955268PQ-2000+ COMPUTED TOMOGRAPHY X-RAY SYSTEMJAK1996-01-30
12581601624393K952684VERTEX EPIC MCDKPS1995-11-24
2426741601624393K952684VERTEX EPIC MCDKPS1995-11-24
12581624597113K952564INSPECT/PROSPECTKPS1995-11-22
2426741624597113K952564INSPECT/PROSPECTKPS1995-11-22
12461782432779K951581PINNACLE3 APEXIYE1996-04-08
2881001782432779K951581PINNACLE3 APEXIYE1996-04-08
12371451354209K951373FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQIXW1995-10-27
12371384747167K946320R 302KPW1995-05-11
12371496310898K945278PHILIPS BUCKY DIAGNOST FAMILYKPR1994-12-14
12581739141321K943623PQ5000 CT SYSTEMJAK1995-04-27
2426741739141321K943623PQ5000 CT SYSTEMJAK1995-04-27
2426741159903406K943596VANTAGE, FOR ADAC GAMMA CAMERASKPS1995-04-26
12371174301747K942481FUJI ULTIMA EC-MA CASSETTEIXA1994-07-29
865301688025296K936084OMNI WARM GEL PACKSIMD1994-03-31
12371084175368K933777CONCEPT ONEIZO1993-12-13
12371043275565K933650PHILIPS XRG 90 X-RAY GENERATOR SYSTEMIZO1993-10-07
12461735066541K926008PINNACLE 3IYE1994-10-04
2881001735066541K926008PINNACLE 3IYE1994-10-04
3204601506781566K905101NEONATAL/STERILE/DISPOS/NONINVAS BLOOD PRESS CUFFDXQ1990-12-20
12581380726319K884268VOXELSCOPE(TM)JAK1988-12-20
2426741380726319K884268VOXELSCOPE(TM)JAK1988-12-20
12581406713958K873075ADAC MODEL ARC-5000, GAMMA CAMERAJWM1987-10-30
2426741406713958K873075ADAC MODEL ARC-5000, GAMMA CAMERAJWM1987-10-30
12581596137549K253649Spectral CT Verida FamilyJAK2026-03-27
3445431881548544K252645LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D HubDQK2025-10-24
2183791211924612K251215Philips IntelliSpace CardiovascularLLZ2025-10-02
12581368217756K250648Philips iCT CT systemJAK2025-06-27
3204601501544618K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)MHX2025-09-02
12581224467713K244008Spectral CTJAK2025-05-16
2183791380672905K241659Ultrasound Workspace (UWS 6.0)QIH2025-02-10
12582018685888K240844Spectral CT 7500 RTJAK2024-10-18
12371415089414K233945ProxiDiagnost N90 / Precision CRF (706110, 706400)JAA2024-01-11
3445431241909007K233853LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D HubDQK2024-03-14
12371765842423K233678Radiography 7000 MIZL2024-02-14
12371788957111K233662Radiography 7300 CKPR2024-06-13
12371315616371K232910CombiDiagnost R90JAA2023-10-19
3445431426558766K223918AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D HubDQK2023-06-08
2183791177659823K213544TOMTEC-ARENAQIH2022-01-06
12581126087719K212875Spectral CT on RailsJAK2022-05-13
12371714820303K212837ProxiDiagnost N90JAA2021-09-21
12371808534816K212186Philips Radiology Smart AssistantKPR2021-12-13
12581994894882K211764Vereos PET/CTKPS2021-08-06
2183792000661369K211046eCareManager 4.5MSX2022-06-03
12581792462691K210880Vereos PET/CTKPS2021-05-19
12371944706471K210692DigitalDiagnostKPR2021-04-02
12371229650080K203087CombiDiagnost R90JAA2020-12-03
12371785372338K202564DigitalDiagnost C90MQB2020-09-30
3445431992464836K201081AltaTrack equipment, AltaTrack Guidewire, AltaTrack CatheterDQK2020-12-17
2183791988380984K200974QLAB Advanced Quantification SoftwareQIH2020-06-03
12581781529071K193454IQon Spectral CTJAK2020-01-24
2426741781529071K193454IQon Spectral CTJAK2020-01-24
2183792000658651K190913QLAB Advanced Quantification Software 13LLZ2019-06-18
12371328282187K182973DigitalDiagnost C90MQB2019-01-11
2183791424151033K181311Philips Hemodynamic Application R1.0MWI2018-09-07
2183791049533428K181264QLAB Advanced Quantification SoftwareLLZ2018-06-07
2183791151018245K180019CAAS WorkstationIZI2018-05-03
12371057308416K173433ProxiDiagnost N90OWB2018-02-05
2183791314221101K172609CSMC Cardiac SuiteKPS2017-11-03
12581739259078K172406Ingenuity TFKPS2017-10-06
2426741739259078K172406Ingenuity TFKPS2017-10-06
12581091718673K171850Philips CT Big BoreJAK2017-11-09
2426741091718673K171850Philips CT Big BoreJAK2017-11-09
12371390798174K171461SkyPlate Detector for Philips Radiography/Fluoroscopy SystemsMQB2017-07-07
3204601035116856K171423Nasal Alar SpO2 SensorDQA2017-07-27
2183791330096492K171314QLAB Advanced Quantification SoftwareLLZ2017-05-30
12371578323279K170113pixium 4343RCEMQB2017-02-09
12461750355423K170086Pinnacle Radiation Therapy Planning SystemMUJ2017-02-09
2881001750355423K170086Pinnacle Radiation Therapy Planning SystemMUJ2017-02-09
12581978554078K163711IQon Spectral CTJAK2017-04-05
2426741978554078K163711IQon Spectral CTJAK2017-04-05
12372010089703K163210Philips CombiDiagnost R90JAA2017-01-31
12582033651223K162838Philips iCT CT SystemJAK2017-04-07
2426742033651223K162838Philips iCT CT SystemJAK2017-04-07
12581602060175K160743Philips Ingenuity CTJAK2016-08-08
2426741602060175K160743Philips Ingenuity CTJAK2016-08-08
12371160681150K153318Philips Eleva Workspot with SkyFlowMQB2015-12-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KPS892021-08-06
JAK412026-03-27
LLZ282025-10-02
MQB132020-09-30
MUJ112017-02-09
DQA82017-07-27
JAA62024-01-11
KPR52024-06-13
DQK42025-10-24
MUE42013-12-13
LNH42011-03-22
IYE41996-04-08
QIH32025-02-10
OWB32018-02-05
IZL22024-02-14
MWI22018-09-07
IZI22018-05-03
HGM22014-11-25
OUO22011-11-23
MQM22001-03-19
DSI22000-05-17
IZO21993-12-13
JWM21987-10-30
MHX12025-09-02
MSX12022-06-03
OED12007-12-20
KXJ12005-03-25
OMJ12004-10-08
MPO12004-01-27
IXR11997-03-21
IXW11995-10-27
KPW11995-05-11
IXA11994-07-29
IMD11994-03-31
DXQ11990-12-20

PMA#

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...

56 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.

Zenition 30

2024-02-16

Philips Medical Systems Nederland B.V.

MR 5300

2021-11-19

Philips Medical Systems Nederland B.V.

Zenition 70

2021-10-01

Philips Medical Systems Nederland BV

200 records. Showing 1-40. Next

GUDID#

DigitalDiagnost - The DigitalDiagnost is a high-end digital radiography system, that includes- Accessory-lead apron for Vertical stand;- Additional SkyPlate charger;- Adjustable Straps for Patient Support;- Compression Belt (singles. pull);- Detector Holder for Patient Bed;- Hand grips (Pair of);- Handle for Skyplate Large;- Infusion bottle holder;- Mobile Detector Holder;- Paper roll holder;- Patient Support for Stitching;- Portable Panel Protector;- Remote control holder;- Set of 50 Hygienic Bags large;- Set of 50 Hygienic Bags small;- Side Bar;- Stretch Grip for VS/VM Stand;- Table top support

Philips Medical Systems DMC GmbH

2016-09-19

DigitalDiagnost - The DigitalDiagnost is a high-end digital radiography system, that includes- Accessory-lead apron for Vertical stand;- Additional SkyPlate charger;- Adjustable Straps for Patient Support;- Compression Belt (singles. pull);- Detector Holder for Patient Bed;- Hand grips (Pair of);- Handle for Skyplate Large;- Infusion bottle holder;- Mobile Detector Holder;- Paper roll holder;- Patient Support for Stitching;- Portable Panel Protector;- Remote control holder;- Set of 50 Hygienic Bags large;- Set of 50 Hygienic Bags small;- Side Bar;- Stretch Grip for VS/VM Stand;- Table top support

Philips Medical Systems DMC GmbH

2016-09-19

DigitalDiagnost - The DigitalDiagnost is a high-end digital radiography system, that includes- Accessory-lead apron for Vertical stand;- Additional SkyPlate charger;- Adjustable Straps for Patient Support;- Compression Belt (singles. pull);- Detector Holder for Patient Bed;- Hand grips (Pair of);- Handle for Skyplate Large;- Infusion bottle holder;- Mobile Detector Holder;- Paper roll holder;- Patient Support for Stitching;- Portable Panel Protector;- Remote control holder;- Set of 50 Hygienic Bags large;- Set of 50 Hygienic Bags small;- Side Bar;- Stretch Grip for VS/VM Stand;- Table top support

Philips Medical Systems DMC GmbH

2016-09-19

DigitalDiagnost C90 - The DigitalDiagnost C90 is a high-end digital radiography system, that inlcudes- Adjustable Straps for Patient Support;- Battery for SkyPlate E;- Compression Belt (singles. pull);- Hand grips (Pair of);- Infusion bottle holder;- Lateral cassette holder;- Mobile Detector Holder;- Paper roll holder;- Parking frame for accessories;- Patient Support for Stitching;- Remote control holder;- Side Bar;- Stretch Grip for VS/VM Stand;- Table top support

Philips Medical Systems DMC GmbH

2019-03-28

DigitalDiagnost C90 - The DigitalDiagnost C90 is a high-end digital radiography system, that inlcudes- Adjustable Straps for Patient Support;- Battery for SkyPlate E;- Compression Belt (singles. pull);- Hand grips (Pair of);- Infusion bottle holder;- Lateral cassette holder;- Mobile Detector Holder;- Paper roll holder;- Parking frame for accessories;- Patient Support for Stitching;- Remote control holder;- Side Bar;- Stretch Grip for VS/VM Stand;- Table top support

Philips Medical Systems DMC GmbH

2019-03-28

CombiDiagnost R90 - The CombiDiagnost R90 is a multi-functional general Radiography/Fluoroscopy (R/F) system.that includes- Adjustable Straps for Patient Support; - Adult headrest;- Ankle Clamps;- Arm Support;- Babix holder vertical stand;- Compression Belt (singles. pull);- Console trolles;- Detector Holder for Patient Bed;- Extra Stitching Ruler;- Hand grips (Pair of);- Handle;- Infusion bottle holder;- Leg Supports (Pair of);- Mattress GXR Systems;- Mobile Detector Holder;- Monitor Ceiling Suspension(Family);- Monitor CS for1 Monitor;- Monitor CS for2 Monitors;- Monitor CS for3 Monitors;- Monitor Trolley Family:- Monitor Trolley for 1 Monitor assembly;- Monitor Trolley for 2 Monitors assembly;- Patient Support for Stitching;- Rotable stool for footrest;- Shoulder supports (Pair of);- Side Bar;- Stretch Grip for VS/VM Stand

Philips Medical Systems DMC GmbH

2021-02-04

80 records. Showing 1-40. Next