Philips Electronics Ltd

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3000126629	3000126629	Philips Electronics Ltd	1	N	2026-01-01	1875 Buckhorn Gate, 5th Floor Mississauga Ontario CA L4W 5P1
8021997	3007577254	PHILIPS ELECTRONICS UK LIMITED	1	N	2020-04-25	LOWER ROAD GLEMSFORD Suffolk GB CO10 7QS
3006988753	3006988753	Philips Electronics Nederland B.V.	1	N	2020-04-25	High Tech Campus 5 Eindhoven Noord-Brabant NL 5656AE

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
283249	1793685059	P960042	SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH	MFA	1997-12-09
283249	1177448740	P180028	HeartStart FRx Defibrillator	MKJ	2020-05-11
283249	1147793398	P160029	HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)	NSA	2019-06-06
283249	1444070357	P160028	Philips HeartStart FR3 Defibrillator	MKJ	2020-05-11
283249	1004592557	P050018	ANGIOSCULPT SCORING BALLOON CATHETER	NWX	2007-01-08
283249	1929009126	K993819	QWH-300 WRIST ARRAY COIL	MOS	1999-12-03
283249	1209117672	K993776	OBC-300 BREAST ARRAY COIL	MOS	1999-12-03
283249	2052297929	K993477	HRW WRIST ARRAY COIL	MOS	1999-11-01
283249	1651853032	K993383	HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B	DSI	2000-02-03
283249	1144147427	K993279	QSC-085 SHOULDER ARRAY COIL	MOS	1999-10-15
283249	1497022755	K992969	RESPIRONICS TOTAL FACE MASK	BZD	1999-11-10
283249	1527164104	K992674	HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A	MHX	1999-11-08
283249	2021081260	K991725	SIDESTREAM NEBULIZER	CAF	1999-07-30
283249	1177303896	K991671	HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM	IYO	1999-06-18
283249	1296732275	K991648	REUSABLE CONTOUR II NASAL MASK	BZD	1999-05-28
283249	1463302134	K991366	DAUM MRI/CONVENTIONAL BIOPSY KIT	KNW	1999-06-25
283249	1705899043	K991105	ECG ELECTRODE (VARIOUS)	DRX	1999-11-26
283249	1072683546	K990713	SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER	DRB	1999-10-22
283249	1326600785	K990339	SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O	IYN	1999-02-18
283249	1794526719	K984286	HEARTSTREAM ELECTRODE ADAPTER	MKJ	1998-12-17
283249	1216971191	K983533	ACTIWATCH	GWQ	1999-03-23
283249	1456544812	K983109	MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY	MOS	1998-10-06
283249	1128069375	K983069	PHILIPS DUO DIAGNOST	OWB	1998-11-02
283249	1102766344	K982795	PHILIPS BUCKY VISION	MQB	1998-11-24
283249	1221684535	K982795	PHILIPS BUCKY VISION	MQB	1998-11-24
283249	1322818088	K982454	BIPAP VISION VENTILATORY SUPPORT	MNT	1998-11-03
283249	1786226061	K982293	PRESSURE TRANSDUCER AIRFLOW SENSOR	MNR	1998-07-13
283249	1087570410	K982283	WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH	BYE	1999-03-09
283249	1860199553	K980327	MICROSTREAM FILTERLINE ICU	CCK	1998-04-16
283249	1463050292	K980324	MICROSTREAM FILLERLINE OR/EMS	CCK	1998-04-16
283249	1721305778	K980074	56 SERIES AEROSOL GENERATOR	CAF	1998-06-12
283249	1078556459	K974631	DAUM NEUROBIOPSY NEEDLE	KNW	1998-03-09
283249	1203409319	K974576	DAUM BIOPSYGUN	KNW	1998-03-06
283249	1169685159	K974575	DAUM ASPIRATIONBIOPSY NEEDLE	KNW	1998-03-06
283249	1692845957	K974574	DAUM NEUROPUNCTURE NEEDLE	KNW	1998-03-06
283249	1735508621	K973437	HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULES	DPS	1997-12-03
283249	1982708844	K972418	HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX)	MKJ	1997-09-25
283249	1870862141	K970868	MODEL HNC NEUROVASCULAR ARRAY COIL	MOS	1997-06-06
283249	1298466081	K970640	PHILIPS EASY DIAGNOST	IXR	1997-03-21
283249	1629689683	K970037	TARGOGRID	LNH	1997-03-12
283249	1021958305	K964668	MODELS EXL AND EXS EXTREMITY COIL SET	MOS	1997-02-18
283249	1932950946	K964653	OASIS HUMIDIFIER	BTT	1997-02-14
283249	1828905146	K964124	PHILIPS COMPUTED RADIOGRAPHY	LLZ	1996-12-18
283249	1837834990	K963894	SMARTGUIDE	FCG	1997-03-11
283249	1248330583	K963794	PUNCTURENEEDLE	KNW	1998-03-19
283249	1432700800	K963380	CO 2 SMO PLUS	BZC	1997-01-22
283249	1720814473	K963250	PRESSURE VALVE	BZD	1996-11-14
283249	1622880562	K962924	PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM	BZH	1996-10-25
283249	1796565463	K962822	OPTICHAMBER	CAF	1996-10-17
283249	1835427081	K962615	TUMORLOCALIZER MRI	MIG	1998-03-19
283249	1348183690	K962203	WHISPER SWIVEL II EXHALATION PORT	BZD	1996-12-05
283249	1767440641	K962070	YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE	FLL	1996-07-19
283249	1904209257	K961525	ARRAY OPEN BREAST COIL (MODEL OBC-63 PA)	MOS	1996-09-05
283249	1479819954	K961366	MODEL #QSC-200-4C AND QSC-165-4C ARRAY SHOULDER COILS	LNH	1996-07-03
283249	1076810569	K961185	DAUM BIOPSYNEEDLE	FCG	1996-04-30
283249	1295111495	K961077	PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE	BWF	1996-07-15
283249	1710146322	K960851	THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSOR	BZQ	1996-09-17
283249	1964967847	K955628	FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS	MKJ	1996-09-10
283249	1645051704	K954190	MODEL 580GE-64 QUADRATURE ABDOMINAL FLEX COIL	MOS	1995-11-20
283249	1324360769	K953392	HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES)	BTT	1996-03-12
24456	1563523731	K952035	NIPLETTE	HGY	1995-07-28
283249	1384747167	K946320	R 302	KPW	1995-05-11
283249	2061232800	K945782	HUMIDIFIER	BTT	1996-03-01
283249	1157441157	K945778	PHASED ARRAY SHOULDER COIL, QUADRATURE SHOULDER COIL	LNH	1995-03-23
283249	1496310898	K945278	PHILIPS BUCKY DIAGNOST FAMILY	KPR	1994-12-14
283249	1949046115	K944331	MODEL 528GE SERIES	LNH	1995-01-25
283249	1067702560	K944177	BREAST SHELL	HFS	1994-10-05
24456	1442594510	K944177	BREAST SHELL	HFS	1994-10-05
283249	1066078008	K944175	ADAM SHELL THERMOCOUPLE ASSEMBLY	BZG	1994-10-14
283249	1174301747	K942481	FUJI ULTIMA EC-MA CASSETTE	IXA	1994-07-29
283249	1984169778	K941025	PHASED ARRAY BREAST COIL	LNH	1994-06-08
283249	1885892932	K940888	SYSTEM 22 PAEDIATRIC MASK	BYG	1994-04-19
283249	1948938314	K940015	SNORING MICROPHONE, SM1	MNR	1995-01-11
283249	1892692110	K940014	PLM SENSOR, MODEL PLM1	BZQ	1994-11-10
283249	1969745267	K940013	BODY POSITION INDICATOR, MODEL BPI1	MNR	1995-05-04
283249	1688025296	K936084	OMNI WARM GEL PACKS	IMD	1994-03-31
283249	1299708266	K934396	QUADRATURE LOWER EXTREMITY COIL	LNH	1993-11-24
283249	2017088172	K933889	PERSONAL BEST LOW RANGE	BZH	1993-09-09
283249	1043275565	K933650	PHILIPS XRG 90 X-RAY GENERATOR SYSTEM	IZO	1993-10-07
283249	1442099931	K932188	SAFESET RESERVOIR	KRA	1993-10-25
283249	1178610098	K925910	HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE	KLK	1993-07-29
283249	1835281738	K924123	SIDESTREAM DISPOSABLE	CAF	1992-11-16
283249	1088748713	K923402	CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR	BZQ	1992-12-30
283249	1662091379	K915460	HEATED RESPIRATORY HUMIDIFIER HC100	BTT	1993-01-15
283249	1965385672	K914103	LIFELINE(R) PERSONAL RESPONSE SYSTEM	ILQ	1991-09-27
283249	1534127686	K913533	MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS)	DXH	1991-11-07
283249	1055335171	K913423	LIFECARE REMOTE ALARM II	CBK	1992-01-30
283249	1062095160	K913396	CANNULA STYLE THERMOCOUPLES	BZG	1992-05-22
283249	1198432078	K913395	EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS	BZG	1992-05-20
283249	1923161294	K913367	MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESS	BTT	1992-06-25
283249	1369588274	K910947	NEV-10 NEGATIVE PRESSURE VENTILATOR	BYT	1991-06-03
283249	1506781566	K905101	NEONATAL/STERILE/DISPOS/NONINVAS BLOOD PRESS CUFF	DXQ	1990-12-20
283249	1896844770	K904935	RESPIRONICS' DIGITAL MANOMETER	CAP	1991-04-03
283249	1491793583	K904185	SENSATRACE	DRX	1990-10-31
283249	1096430730	K902292	MODIFIED ASSESS(R) PEAK FLOW METER	BZH	1990-08-10
283249	1332864595	K900682	PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE	DRY	1990-07-31
283249	1346345805	K895849	RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM	BYT	1989-12-22
283249	1788337621	K894361	LIFECARE PRESSURE ALARM CAT. NO. 34-010	CAP	1989-10-05
283249	1420882231	K892355	M1300A ULTRASOUND IMAGING SYSTEM, M1321A 3.5 MHZ	IYO	1989-07-24
283249	2058340407	K884421	PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT	DXQ	1989-01-13
283249	1819735425	K883825	MODIFIED SANDERS BI-PAPEASY	BYE	1988-12-08
283249	2036379381	K883793	DISPOSABLE TEMPERATURE PROBES (SEVERAL MODELS)	FLL	1988-11-21
283249	1776635483	K871412	CONTOUR SOFT-E SERIES CONDUCTIVE SOLID GEL ELECTRO	DRX	1987-05-12
283249	1215560940	K870962	GESCO ASPIRATOR	BSY	1987-05-22
283249	1053923990	K870514	THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER	BWF	1987-03-31
283249	1445101771	K844856	ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON	DRX	1985-02-20
283249	1839843310	K844345	CONTOUR ELECTRODE	DRX	1985-01-02
283249	1853973679	K843262	TRANSESOPHAGEAL ECHOCARDIOGRAPHY ULTRASO	JOP	1984-08-23
283249	1358239901	K842876	PORTABLE LIFECARE VENTILATOR PLV-102	CBK	1984-08-29
283249	1215829370	K792020	AE 840 PHYSIOLOGICAL PRESSURE TRANSDUCER	DRS	1979-12-07
283249	1209679070	K790305	ELECTRODES, FERRIS ECG, TYPES 905,906	DRX	1979-04-03
283249	1002933266	K242670	Lumify Diagnostic Ultrasound System	IYN	2025-05-08
283249	2023505101	K242519	Lumify Diagnostic Ultrasound System	IYN	2025-05-15
283249	2018685888	K240844	Spectral CT 7500 RT	JAK	2024-10-18
283249	1792045194	K233555	AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask	BZD	2024-07-31
283249	1679561529	K233204	Philips IntelliSite Pathology Solution 5.1	PSY	2024-06-24
283249	1048670297	K232491	CT 5300	JAK	2024-05-03
283249	1086586942	K231671	IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468)	MHX	2023-12-19
283249	1465817488	K231190	EPIQ Series Diagnostic Ultrasound System	IYN	2023-05-12
283249	1729933378	K222648	5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W)	IYN	2022-09-27

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
MOS	76	2021-12-23
IYN	37	2025-05-15
BZD	36	2024-07-31
MHX	35	2023-12-19
LLZ	23	2020-09-20
DQA	18	2017-07-27
CBK	17	2020-05-04
LNH	14	2019-06-04
CAF	14	2017-11-02
JAK	12	2024-10-18
CCK	11	2017-12-26
DRX	11	2009-08-21
OBJ	9	2020-09-02
MKJ	9	2013-10-18
KPS	8	2021-08-06
MQB	8	2020-09-30
DSI	8	2015-07-17
MNS	8	2012-02-01
MNR	8	2009-06-26
MWI	7	2015-12-23
BTT	7	2008-03-31
KNW	6	1999-06-25
DQX	5	2021-04-15
DPS	4	2022-12-02
MSX	4	2019-04-26
OWB	4	2018-12-31
DXJ	4	2018-07-16
IYO	4	2017-12-13
MUE	4	2013-12-13
BZQ	4	2013-04-12
FLL	4	2004-04-22
DSJ	3	2019-10-27
HGM	3	2018-09-10
DXQ	3	2015-10-27
CAW	3	2011-11-04
BZK	3	2011-06-02
HGY	3	2010-11-05
BZH	3	1996-10-25
BZG	3	1994-10-14
OLZ	2	2020-10-29

PMN#

Philips IntelliSite Pathology Solution

2019-09-20

Philips Electronics Nederland B.V.

Philips BlueControl

2017-07-06

Philips Electronics Nederland B.V.

HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)

2010-11-05

PHILIPS ELECTRONICS UK LIMITED

PHILIPS AVENT DIGITAL THERMOMETER SET, MODEL SCH540

2010-06-22

PHILIPS ELECTRONICS UK LIMITED

PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS AVENT ANIMAL STAGE 2 AND 3 TEETHER,

2009-06-18

Philips Electronics UK Limited