FDA.reportPublic FDA data

Philips North America LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12189501218950Philips North America LLC1N2026-01-013000 Minuteman Rd ANDOVER MA US 01810
30306771000524572Philips North America LLC1N2026-01-0122100 Bothell Everett Hwy Bothell WA US 98021
30066483203006648320Philips North America LLC1N2026-01-01222 Jacobs Street Cambridge MA US 02141
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
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

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
12571177448740P180028HeartStart FRx DefibrillatorMKJ2020-05-11
2228091177448740P180028HeartStart FRx DefibrillatorMKJ2020-05-11
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
12571444070357P160028Philips HeartStart FR3 DefibrillatorMKJ2020-05-11
2228091444070357P160028Philips HeartStart FR3 DefibrillatorMKJ2020-05-11
12351771960806K994188MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5CBQ2000-05-19
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
12351527164104K992674HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027AMHX1999-11-08
12351605326894K992595HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT MEASUREMENT, HP VIRIDIA CMS 24/26, REV K WITHMHX1999-12-08
12351320908583K992273HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR M3000A/M3046A/M3016A,REL BMHX2000-01-28
12351602486209K991773HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PDSI1999-06-07
12351080299950K990972HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE TDSI1999-04-19
12351042028767K990476HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, MODEL REV. K WITH EASI-ECG OPTIONMHX1999-07-22
12351853071026K990199SMARTRECORDER, MODEL 2500MNR1999-04-19
12351824423863K990125HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. KDSI1999-01-29
12571794526719K984286HEARTSTREAM ELECTRODE ADAPTERMKJ1998-12-17
2228091794526719K984286HEARTSTREAM ELECTRODE ADAPTERMKJ1998-12-17
12351105409019K982619HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02CCL1998-08-12
12351087570410K982283WHISPERFLOW 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
12351672284237K981576MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046AMHX1998-07-17
12351860199553K980327MICROSTREAM FILTERLINE ICUCCK1998-04-16
2491751860199553K980327MICROSTREAM 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
12351851409731K980045CENTURION CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEMDSI1998-11-16
12351374506456K974087MODEL M1792A THROMBOLYTIC PREDICTIVE INSTRUMENTLOS1998-06-15
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
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
12351595911040K971910MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A)DSI1998-03-23
12351166426109K970629TANGO NON-INVASIVE BLOOD PRESSURE MONITORDXN1998-01-02
12351767440641K962070YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBEFLL1996-07-19
2491751767440641K962070YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBEFLL1996-07-19
12571964967847K955628FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADSMKJ1996-09-10
12351315258250K954351SERIES 50XMHGM1996-03-08
12351315141283K953649DISPOSABLE ECG ELECTRODEDRX1996-06-21
2491751315141283K953649DISPOSABLE ECG ELECTRODEDRX1996-06-21
12351538049769K951127HEWLETT-PACKARD MODEL M1026A ANESTHETIC GAS MODULECCK1995-03-24
12351998443294K943389SIDESTREAM PUMP PLUG-IN MODULE OF COMPONENT MONITORING SYSTEMCCK1995-03-17
12351227859064K942887MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEMHGM1994-08-15
12351520701716K942842HEWLETT-PACKARD M1021A MIX VEN OXY SAT PLUG-IN MODULEDQA1995-02-16
12351515406791K941811HP M1175A, M1176A, COMPONENT MONITORING SYSTEMDPS1994-05-17
12351688025296K936084OMNI WARM GEL PACKSIMD1994-03-31
12351442099931K932188SAFESET RESERVOIRKRA1993-10-25
12351178610098K925910HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULEKLK1993-07-29
12351524143599K922058MODELS M1175A AND M1176A COMPONENT MONITORING SYSTMHX1992-10-06
12351571462277K921957HEWLETT-PACKARD MODEL M1351A FETAL MONITORHGM1993-09-24
12352053715124K921956HEWLETT PACKARD MODEL M1353A FETAL MONITORHGM1993-09-24
12351065959039K921561YSI MODELS 4400 FOLEY CATHETER TEMPERATURE PROBESEZL1992-11-23
2491751065959039K921561YSI MODELS 4400 FOLEY CATHETER TEMPERATURE PROBESEZL1992-11-23
12351534127686K913533MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS)DXH1991-11-07
2491751534127686K913533MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS)DXH1991-11-07
12351193708590K913516MODEL 520A NOVAMETRIX PULSE OXIMETERDQA1991-11-04
12351506781566K905101NEONATAL/STERILE/DISPOS/NONINVAS BLOOD PRESS CUFFDXQ1990-12-20
2491751506781566K905101NEONATAL/STERILE/DISPOS/NONINVAS BLOOD PRESS CUFFDXQ1990-12-20
12351491793583K904185SENSATRACEDRX1990-10-31
2491751491793583K904185SENSATRACEDRX1990-10-31
12352035906462K903379PYMAH PRE-GAGED BALANCED TEMPA-KUFFDXQ1990-10-19
12351332864595K900682PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODEDRY1990-07-31
2491751332864595K900682PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODEDRY1990-07-31
12351319563851K900480M1350A FETAL MONITOR (INTRAPARTUM)HGM1990-07-02
12351412411253K896216HEWLETT PACKARD ANESTHETIC GAS ANALYZER M1025ACBS1990-01-16
12351809663892K893643NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETERDQA1989-10-26
12351524306420K893409YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMPBZT1989-07-20
12351023858316K890817OMNI-TRAK (PATIENT MONITOR)CCK1989-08-10
12352058340407K884421PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREATDXQ1989-01-13
12352036379381K883793DISPOSABLE TEMPERATURE PROBES (SEVERAL MODELS)FLL1988-11-21
12351976724087K880320ELECTRODE CABLEDSA1988-03-22
12351776635483K871412CONTOUR SOFT-E SERIES CONDUCTIVE SOLID GEL ELECTRODRX1987-05-12
2491751776635483K871412CONTOUR SOFT-E SERIES CONDUCTIVE SOLID GEL ELECTRODRX1987-05-12
12351372827714K864730INVIVO PULSE OXIMETER, MODEL 4500DQA1987-05-06
12351445101771K844856ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NONDRX1985-02-20
12351839843310K844345CONTOUR ELECTRODEDRX1985-01-02
12351968589157K843273DISPOS. PRESSURE KIT 1295K SERIESDRS1985-06-11
12351853973679K843262TRANSESOPHAGEAL ECHOCARDIOGRAPHY ULTRASOJOP1984-08-23
12351876885156K842817MODEL 78353BDRT1985-06-06
12351741512411K842236PATIENT MONITOR 78354ADRT1985-01-18
12351169017969K841944DISPOSABLE ECG ELECTRODEDRX1985-03-01
12351724186131K841613PRESSURE TRANSDUCER DOME 1295CDRS1984-10-24
12351514641640K831787PATIENT MONITOR #78353ADRT1983-09-29
12351701864351K831447CAPNOMETER W/NEW AIRWAY ADAPTER 47210ACCK1983-11-21
12351763840473K813639SERIES 400 DISPOSABLE TEMPERATURE PROBEFLL1982-01-22
12351551951385K810838NEONATAL BLOOD PRESSURE CUFFDXQ1981-04-03
12351001661872K800066NIASTATDXN1980-02-29
12351215829370K792020AE 840 PHYSIOLOGICAL PRESSURE TRANSDUCERDRS1979-12-07
12351209679070K790305ELECTRODES, FERRIS ECG, TYPES 905,906DRX1979-04-03
2491751209679070K790305ELECTRODES, FERRIS ECG, TYPES 905,906DRX1979-04-03
12351076530995K780324CAPNOMETER MODEL 47210ACCK1978-03-14
12351582094748K771361PHYSIOLOGICAL PRESSURE TRANSDUCER 1290ADRS1977-08-04
2491751806678114K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)MHX2026-02-06
2491751364558779K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 )MHX2025-11-10
2491751497062134K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550MHX2025-10-17
3107601230545298K213335Capsule Surveillance SystemMWI2022-01-14
2491751064711372K212227Philips MR Patient Care PortalMWI2021-09-30
2491751109162191K211900Patient Information Center iXMHX2022-03-04
2491751162263952K210560Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 CardiographDPS2021-06-30
3107601900080575K210204Capsule Vitals Plus Patient Monitoring SystemMWI2021-10-19
12571668874738K203231Switched Internal PaddlesLDD2021-01-11
2491751212146795K193228Hamilton-G5CBK2020-05-04
2491751796658307K192875Philips Biosensor BX100DRG2020-04-16
3107601517928810K183638SmartLinx Vitals Plus Patient Monitoring SystemMWI2019-04-17
12351349190051K183387M3290B Patient Information Center iXMHX2019-08-06
2491751349190051K183387M3290B Patient Information Center iXMHX2019-08-06
2491751936654198K181624Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling LineCCK2019-03-22
2491752049765561K181467Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter LineCCK2019-02-08
2491751568523532K181216HAMILTON-T1, HAMILTON-C1CBK2019-08-02
3107601479046126K180734SmartLinx Vitals Plus Patient Monitoring SystemMWI2018-08-08
2491751263637701K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1CBK2019-03-19
12351412845389K180017MX40 Release C.01MHX2018-07-24
2491751412845389K180017MX40 Release C.01MHX2018-07-24
2492711018225353K173941IntelliSpace Perinatal Rev.K.00HGM2018-09-10

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MHX812026-02-06
MKJ302015-01-23
CCK292019-03-22
DRX292009-08-21
MWI282022-01-14
DQA232017-07-27
HGM152018-09-10
DSI152015-07-17
MSX132016-06-24
DPS102021-06-30
DXN102012-02-14
CBK82020-05-04
DXQ72015-10-27
DRS72006-09-19
BSZ62008-12-18
DSJ52017-03-31
DQK52012-07-18
MKJ 42020-05-11
NSA42019-06-06
DSA42011-02-15
MWJ42007-07-24
DRT42005-01-10
DXH42000-09-21
FLL41996-07-19
DRG32020-04-16
DXJ32015-10-30
BZQ32014-03-26
BZK32011-06-02
LDD22021-01-11
OSP22014-08-27
OED22007-12-20
CBQ22004-04-29
MPO22004-01-27
CCL22003-03-28
MLO22001-09-28
MQM22001-03-19
EZL21992-11-23
DRY21990-07-31
LKD12011-09-30
MNT12011-04-05

PMN#

GUDID#

200 records. Showing 1-40. Next