Data / Medical devices / Canada / Philips Electronics Ltd

Philips Electronics Ltd: FDA-registered device maker in Mississauga Ontario, Canada, 522 510(k) clearances and 5 PMA approvals

Name: Philips Electronics Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Philips Electronics Ltd is registered with the FDA (registration 3000126629) in Mississauga Ontario, Canada. It lists 195 device types. The FDA files 522 510(k) clearances and 5 PMA approvals under its listings, the newest dated May 15, 2025. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Philips Electronics Ltd

FDA registration number: 3000126629
Address: 1875 Buckhorn Gate, 5th Floor, Mississauga Ontario, Canada, L4W 5P1
Owner or operator: Philips Medical Systems International BV (1217116)
Roles: Exporter to the US
First device listed: November 19, 1992
Registered through: 2026
Brand names listed: 0.6T Marconi Wrist and Hand Array, 0.6T Panorama 4Ch Breast Array, 0.9 OTW TURBO ELITE, 05-10000 - Heartstream Pads to QUIK-COMBO Adapter [FR2], 05-10100 - Heartstream Pads to Zoll Adapter, 1.5T 16CH Cardiac Coil- Anterior, 1.5T 16CH Cardiac Coil- Posterior, 1.5T 16Ch GE Shoulder Coil and more

Devices it lists

Device	Product code	Class	Role	Source
Adaptor, Lead Switching, Electrocardiograph	DRW	2	Exporter to the US	accessdata.fda.gov
Aid, Cardiopulmonary Resuscitation	LIX	2	Exporter to the US	accessdata.fda.gov
Airway, Oropharyngeal, Anesthesiology	CAE	1	Exporter to the US	accessdata.fda.gov
Alarm, Blood-Pressure	DSJ	2	Exporter to the US	accessdata.fda.gov
Amplifier And Signal Conditioner, Transducer Signal	DRQ	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	NHO	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	CBQ	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	CBS	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	NHQ	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	CBR	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Oxygen, Gaseous-Phase	CCL	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	NHP	2	Exporter to the US	accessdata.fda.gov
Analyzer, Spectrum, Electroencephalogram Signal	GWS	1	Exporter to the US	accessdata.fda.gov
Antimicrobial Blood Pressure Cuff	OED	2	Exporter to the US	accessdata.fda.gov
Assembly, Tube Housing, X-Ray, Diagnostic	ITY	1	Exporter to the US	accessdata.fda.gov
Attachment, Breathing, Positive End Expiratory Pressure	BYE	2	Exporter to the US	accessdata.fda.gov
Automated External Defibrillators (Non-Wearable)	MKJ	3	Exporter to the US	accessdata.fda.gov
Automated Radiological Image Processing Software	QIH	2	Exporter to the US	accessdata.fda.gov
Automatic Event Detection Software For Polysomnograph With Electroencephalograph	OLZ	2	Exporter to the US	accessdata.fda.gov
Bilirubin (Total And Unbound) In The Neonate Test System	MQM	1	Exporter to the US	accessdata.fda.gov
Biopsy Needle	FCG	2	Exporter to the US	accessdata.fda.gov
Blood Pressure Cuff	DXQ	2	Exporter to the US	accessdata.fda.gov
Burst Suppression Detection Software For Electroencephalograph	ORT	2	Exporter to the US	accessdata.fda.gov
Cable, Electrode	IKD	2	Exporter to the US	accessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)	DSA	2	Exporter to the US	accessdata.fda.gov
Calculator, Pulmonary Function Data	BZC	2	Exporter to the US	accessdata.fda.gov
Calculator/Data Processing Module, For Clinical Use	JQP	1	Exporter to the US	accessdata.fda.gov
Cannula, Nasal, Oxygen	CAT	1	Exporter to the US	accessdata.fda.gov
Cassette, Radiographic Film	IXA	2	Exporter to the US	accessdata.fda.gov
Catheter For Crossing Total Occlusions	PDU	2	Exporter to the US	accessdata.fda.gov
Catheter, Continuous Flush	KRA	2	Exporter to the US	accessdata.fda.gov
Catheter, Intravascular Occluding, Temporary	MJN	2	Exporter to the US	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Exporter to the US	accessdata.fda.gov
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring	NWX	3	Exporter to the US	accessdata.fda.gov
Catheter, Percutaneous, Cutting/Scoring	PNO	2	Exporter to the US	accessdata.fda.gov
Catheter, Peripheral, Atherectomy	MCW	2	Exporter to the US	accessdata.fda.gov
Catheter, Ultrasound, Intravascular	OBJ	2	Exporter to the US	accessdata.fda.gov
Catheters, Suction, Tracheobronchial	BSY	1	Exporter to the US	accessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)	CAI	1	Exporter to the US	accessdata.fda.gov
Coil, Magnetic Resonance, Specialty	MOS	2	Exporter to the US	accessdata.fda.gov
Collimator, Automatic, Radiographic	IZW	2	Exporter to the US	accessdata.fda.gov
Compressor, Air, Portable	BTI	2	Exporter to the US	accessdata.fda.gov
Computer, Blood-Pressure	DSK	2	Exporter to the US	accessdata.fda.gov
Computer, Diagnostic, Pre-Programmed, Single-Function	DXG	2	Exporter to the US	accessdata.fda.gov
Computer, Diagnostic, Programmable	DQK	2	Exporter to the US	accessdata.fda.gov
Connector, Airway (Extension)	BZA	1	Exporter to the US	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Exporter to the US	accessdata.fda.gov
Continuous, Minimal Ventilatory Support, Facility Use Ventilator	MNT	2	Exporter to the US	accessdata.fda.gov
Continuous, Ventilator, Home Use	NOU	2	Exporter to the US	accessdata.fda.gov
Dc-Defibrillator, Low-Energy, (Including Paddles)	LDD	2	Exporter to the US	accessdata.fda.gov
Detector And Alarm, Arrhythmia	DSI	2	Exporter to the US	accessdata.fda.gov
Device, Anti-Snoring	LRK	2	Exporter to the US	accessdata.fda.gov
Device, Beam Limiting, X-Ray, Diagnostic	KPW	2	Exporter to the US	accessdata.fda.gov
Device, Biofeedback	HCC	2	Exporter to the US	accessdata.fda.gov
Device, Medical Examination, Ac Powered	KZF	1	Exporter to the US	accessdata.fda.gov
Device, Positive Pressure Breathing, Intermittent	NHJ	2	Exporter to the US	accessdata.fda.gov
Device, Removal, Pacemaker Electrode, Percutaneous	MFA	3	Exporter to the US	accessdata.fda.gov
Device, Spot-Film	IXL	2	Exporter to the US	accessdata.fda.gov
Dilator, Vessel, For Percutaneous Catheterization	DRE	2	Exporter to the US	accessdata.fda.gov
Display, Cathode-Ray Tube, Medical	DXJ	2	Exporter to the US	accessdata.fda.gov
Drain, Tee (Water Trap)	BYH	1	Exporter to the US	accessdata.fda.gov
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	ERL	2	Exporter to the US	accessdata.fda.gov
Electrocardiograph	DPS	2	Exporter to the US	accessdata.fda.gov
Electrocardiograph, Ambulatory, With Analysis Algorithm	MLO	2	Exporter to the US	accessdata.fda.gov
Electrode, Circular (Spiral), Scalp And Applicator	HGP	2	Exporter to the US	accessdata.fda.gov
Electrode, Electrocardiograph	DRX	2	Exporter to the US	accessdata.fda.gov
Electrode, Ion Specific, Calcium	JFP	2	Exporter to the US	accessdata.fda.gov
Electrode, Ion Specific, Potassium	CEM	2	Exporter to the US	accessdata.fda.gov
Electrode, Ion Specific, Sodium	JGS	2	Exporter to the US	accessdata.fda.gov
Electrode, Ion-Specific, Chloride	CGZ	2	Exporter to the US	accessdata.fda.gov
Endoscopic Bite Block	MNK	1	Exporter to the US	accessdata.fda.gov
Exerciser, Measuring	ISD	2	Exporter to the US	accessdata.fda.gov
Full Field Digital, System, X-Ray, Mammographic	MUE	2	Exporter to the US	accessdata.fda.gov
Full-Montage Standard Electroencephalograph	GWQ	2	Exporter to the US	accessdata.fda.gov
Gas, Calibration (Specified Concentration)	BXK	1	Exporter to the US	accessdata.fda.gov
Gas-Machine, Anesthesia	BSZ	2	Exporter to the US	accessdata.fda.gov
Generator, Electroencephalograph Test Signal	GWR	1	Exporter to the US	accessdata.fda.gov
Generator, High-Voltage, X-Ray, Diagnostic	IZO	1	Exporter to the US	accessdata.fda.gov
Generator, Oxygen, Portable	CAW	2	Exporter to the US	accessdata.fda.gov
Grid, Radiographic	IXJ	1	Exporter to the US	accessdata.fda.gov
Guide, Needle, Surgical	GDF	1	Exporter to the US	accessdata.fda.gov
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	BZE	2	Exporter to the US	accessdata.fda.gov
Holder, Radiographic Cassette, Wall-Mounted	IXY	1	Exporter to the US	accessdata.fda.gov
Holding Chambers, Direct Patient Interface	NVP	2	Exporter to the US	accessdata.fda.gov
Humidifier, Respiratory Gas, (Direct Patient Interface)	BTT	2	Exporter to the US	accessdata.fda.gov
Image-Intensified Fluoroscopic X-Ray System, Mobile	OXO	2	Exporter to the US	accessdata.fda.gov
Index-Generating Electroencephalograph Software	OLW	2	Exporter to the US	accessdata.fda.gov
Infant Heel Warmer (Chemical Heat Pack)	MPO	1	Exporter to the US	accessdata.fda.gov
Instrument, Biopsy	KNW	2	Exporter to the US	accessdata.fda.gov
Instrument, Quality-Assurance, Radiologic	LHO	1	Exporter to the US	accessdata.fda.gov
Interventional Fluoroscopic X-Ray System	OWB	2	Exporter to the US	accessdata.fda.gov
Intra-Pulmonary Percussive Vibration (Ipv) Devices	SDT	2	Exporter to the US	accessdata.fda.gov
Marker, Radiographic, Implantable	NEU	2	Exporter to the US	accessdata.fda.gov
Mask, Oxygen	BYG	1	Exporter to the US	accessdata.fda.gov
Mask, Oxygen, Non-Rebreathing	KGB	1	Exporter to the US	accessdata.fda.gov
Medical Device Data System	OUG	1	Exporter to the US	accessdata.fda.gov
Meter, Peak Flow, Spirometry	BZH	2	Exporter to the US	accessdata.fda.gov
Mixer, Breathing Gases, Anesthesia Inhalation	BZR	2	Exporter to the US	accessdata.fda.gov
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	CAP	2	Exporter to the US	accessdata.fda.gov
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass	DRY	2	Exporter to the US	accessdata.fda.gov
Monitor, Breathing Frequency	BZQ	2	Exporter to the US	accessdata.fda.gov
Monitor, Carbon-Dioxide, Cutaneous	LKD	2	Exporter to the US	accessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	DRT	2	Exporter to the US	accessdata.fda.gov
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia	KLK	2	Exporter to the US	accessdata.fda.gov
Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia	LPP	2	Exporter to the US	accessdata.fda.gov
Monitor, Patient Position, Light-Beam	IWE	1	Exporter to the US	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Exporter to the US	accessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	MHX	2	Exporter to the US	accessdata.fda.gov
Monitor, St Segment	MLC	2	Exporter to the US	accessdata.fda.gov
Monitor, St Segment With Alarm	MLD	2	Exporter to the US	accessdata.fda.gov
Monitor, Uterine Contraction, External (For Use In Clinic)	HFM	2	Exporter to the US	accessdata.fda.gov
Mouthpiece, Breathing	BYP	1	Exporter to the US	accessdata.fda.gov
Nebulizer (Direct Patient Interface)	CAF	2	Exporter to the US	accessdata.fda.gov
Non-Normalizing Quantitative Electroencephalograph Software	OLT	2	Exporter to the US	accessdata.fda.gov
Over-The-Counter Automated External Defibrillator	NSA	3	Exporter to the US	accessdata.fda.gov
Oximeter	DQA	2	Exporter to the US	accessdata.fda.gov
Oximeter, Ear	DPZ	2	Exporter to the US	accessdata.fda.gov
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)	DRO	2	Exporter to the US	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Exporter to the US	accessdata.fda.gov
Percussor, Powered-Electric	BYI	2	Exporter to the US	accessdata.fda.gov
Ph Rate Measurement, Carbon-Dioxide	JFL	2	Exporter to the US	accessdata.fda.gov
Pillow, Cervical (For Mild Sleep Apnea)	MYB	2	Exporter to the US	accessdata.fda.gov
Plethysmograph, Impedance	DSB	2	Exporter to the US	accessdata.fda.gov
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic	JOM	2	Exporter to the US	accessdata.fda.gov
Probe, Thermodilution	KRB	2	Exporter to the US	accessdata.fda.gov
Pump, Breast, Non-Powered	HGY	1	Exporter to the US	accessdata.fda.gov
Pump, Breast, Powered	HGX	2	Exporter to the US	accessdata.fda.gov
Recorder, Magnetic Tape, Medical	DSH	2	Exporter to the US	accessdata.fda.gov
Recorder, Paper Chart	DSF	1	Exporter to the US	accessdata.fda.gov
Reduced- Montage Standard Electroencephalograph	OMC	2	Exporter to the US	accessdata.fda.gov
Reminder, Medication	NXQ	1	Exporter to the US	accessdata.fda.gov
Scale, Patient	FRW	1	Exporter to the US	accessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)	BZO	1	Exporter to the US	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Exporter to the US	accessdata.fda.gov
Shield, Nipple	HFS	1	Exporter to the US	accessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	2	Exporter to the US	accessdata.fda.gov
Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide	JKS	1	Exporter to the US	accessdata.fda.gov
Spirometer, Diagnostic	BZG	2	Exporter to the US	accessdata.fda.gov
Spirometer, Monitoring (W/Wo Alarm)	BZK	2	Exporter to the US	accessdata.fda.gov
Spirometer, Therapeutic (Incentive)	BWF	2	Exporter to the US	accessdata.fda.gov
Standard Polysomnograph With Electroencephalograph	OLV	2	Exporter to the US	accessdata.fda.gov
Stethoscope Head	BZS	1	Exporter to the US	accessdata.fda.gov
Stethoscope, Manual	LDE	1	Exporter to the US	accessdata.fda.gov
Stimulator, Nerve, Peripheral, Electric	KOI	2	Exporter to the US	accessdata.fda.gov
Strap, Head, Gas Mask	BTK	1	Exporter to the US	accessdata.fda.gov
Strip, Temperature, Forehead, Liquid Crystal	KPD	2	Exporter to the US	accessdata.fda.gov
Strip, Test Isoniazid	MIG	U	Exporter to the US	accessdata.fda.gov
Stylet, Catheter	DRB	2	Exporter to the US	accessdata.fda.gov
System, Balloon, Intra-Aortic And Control	DSP	2	Exporter to the US	accessdata.fda.gov
System, Communication, Powered	ILQ	2	Exporter to the US	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Exporter to the US	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Exporter to the US	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Exporter to the US	accessdata.fda.gov
System, Isokinetic Testing And Evaluation	IKK	2	Exporter to the US	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Exporter to the US	accessdata.fda.gov
System, Monitoring, Perinatal	HGM	2	Exporter to the US	accessdata.fda.gov
System, Network And Communication, Physiological Monitors	MSX	2	Exporter to the US	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	2	Exporter to the US	accessdata.fda.gov
System, Nuclear Magnetic Resonance Spectroscopic	LNI	2	Exporter to the US	accessdata.fda.gov
System, Planning, Radiation Therapy Treatment	MUJ	2	Exporter to the US	accessdata.fda.gov
System, Signal Isolation	DRJ	1	Exporter to the US	accessdata.fda.gov
System, Tomography, Computed, Emission	KPS	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Angiographic	IZI	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Mobile	IZL	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Stationary	KPR	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Exporter to the US	accessdata.fda.gov
Table, Radiographic, Non-Tilting, Powered	IZZ	2	Exporter to the US	accessdata.fda.gov
Table, Radiographic, Stationary Top	IXQ	2	Exporter to the US	accessdata.fda.gov
Table, Radiographic, Tilting	IXR	2	Exporter to the US	accessdata.fda.gov
Table, Radiologic	KXJ	2	Exporter to the US	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Exporter to the US	accessdata.fda.gov
Tester, Electrode, Surface, Electrocardiographic	KRC	2	Exporter to the US	accessdata.fda.gov
Toothbrush, Powered	JEQ	1	Exporter to the US	accessdata.fda.gov
Transducer, Blood-Pressure, Extravascular	DRS	2	Exporter to the US	accessdata.fda.gov
Transducer, Gas Flow	BXP	1	Exporter to the US	accessdata.fda.gov
Transducer, Pressure, Catheter Tip	DXO	2	Exporter to the US	accessdata.fda.gov
Transducer, Pressure, Intrauterine	HFN	2	Exporter to the US	accessdata.fda.gov
Transducer, Ultrasonic	JOP	2	Exporter to the US	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Exporter to the US	accessdata.fda.gov
Transducer, Ultrasonic, Obstetric	HGL	2	Exporter to the US	accessdata.fda.gov
Transmitters And Receivers, Electrocardiograph, Telephone	DXH	2	Exporter to the US	accessdata.fda.gov
Transmitters And Receivers, Physiological Signal, Radiofrequency	DRG	2	Exporter to the US	accessdata.fda.gov
Tube Mount, X-Ray, Diagnostic	IYB	1	Exporter to the US	accessdata.fda.gov
Unit, Oral Irrigation	EFS	1	Exporter to the US	accessdata.fda.gov
Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile	NOB	1	Exporter to the US	accessdata.fda.gov
Urinometer, Electrical	EXS	2	Exporter to the US	accessdata.fda.gov
Ventilator, Continuous, Facility Use	CBK	2	Exporter to the US	accessdata.fda.gov
Ventilator, Continuous, Non-Life-Supporting	MNS	2	Exporter to the US	accessdata.fda.gov
Ventilator, External Body, Negative Pressure, Adult (Cuirass)	BYT	2	Exporter to the US	accessdata.fda.gov
Ventilator, Non-Continuous (Respirator)	BZD	2	Exporter to the US	accessdata.fda.gov
Ventilatory Effort Recorder	MNR	2	Exporter to the US	accessdata.fda.gov
Whole Slide Imaging System	PSY	2	Exporter to the US	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Exporter to the US	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 522.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 15, 2025	K242519	Lumify Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Ultrasound	accessdata.fda.gov
May 8, 2025	K242670	Lumify Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Ultrasound	accessdata.fda.gov
October 18, 2024	K240844	Spectral CT 7500 RT	JAK	Substantially Equivalent	Philips Medical Systems Technologies , Ltd.	accessdata.fda.gov
July 31, 2024	K233555	AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask	BZD	Substantially Equivalent	Philips Respironics	accessdata.fda.gov
June 24, 2024	K233204	Philips IntelliSite Pathology Solution 5.1	PSY	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
May 3, 2024	K232491	CT 5300	JAK	Substantially Equivalent	Philips Healthcare (Suzhou) Co., Ltd.	accessdata.fda.gov
December 19, 2023	K231671	IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468)	MHX	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
May 12, 2023	K231190	EPIQ Series Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Ultrasound, LLC	accessdata.fda.gov
December 2, 2022	K221141	PageWriter TC35 Cardiograph	DPS	Substantially Equivalent	Medizin Systeme Boblingen GmbH	accessdata.fda.gov
September 27, 2022	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	Substantially Equivalent	Philips Ultrasound, LLC	accessdata.fda.gov
May 13, 2022	K212875	Spectral CT on Rails	JAK	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
December 23, 2021	K213766	dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T	MOS	Substantially Equivalent	Invivo Corporation	accessdata.fda.gov
October 7, 2021	K210906	IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4	MHX	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
September 24, 2021	K212704	Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Medical Systems	accessdata.fda.gov
September 8, 2021	K211597	EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Medical Systems	accessdata.fda.gov
August 6, 2021	K211764	Vereos PET/CT	KPS	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
May 19, 2021	K210880	Vereos PET/CT	KPS	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
April 15, 2021	K210235	Verrata PLUS Pressure Guide Wire	DQX	Substantially Equivalent	Volcano Corporation	accessdata.fda.gov
October 29, 2020	K202142	Sleepware G3	OLZ	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
October 1, 2020	K201381	Philips Avent Single/Double electric breast pump Advanced	HGX	Substantially Equivalent	Philips Consumer Lifestyle - Innovation Site Eindhoven	accessdata.fda.gov
September 30, 2020	K202564	DigitalDiagnost C90	MQB	Substantially Equivalent	Philips Medical Systems Dmc GmbH	accessdata.fda.gov
September 28, 2020	K202543	OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip	DQX	Substantially Equivalent	Volcano Corporation	accessdata.fda.gov
September 25, 2020	K201439	Ventilator, Non-continuous (Respirator)	BZD	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
September 20, 2020	K200603	AAA Model	LLZ	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
September 15, 2020	K201665	Collaboration Live	LLZ	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
September 11, 2020	K192137	IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550	MHX	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
September 2, 2020	K202216	EPIQ Series Diagnostic Ultrasound Systems	IYN	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
September 2, 2020	K200812	VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter	OBJ	Substantially Equivalent	Philips Image Guided Therapy Corporation	accessdata.fda.gov
August 17, 2020	K201352	3D Auto LAA	LLZ	Substantially Equivalent	Philips Health Care	accessdata.fda.gov
August 14, 2020	K201632	TOMTEC-ARENA	LLZ	Substantially Equivalent	Tomtec Imaging Systems GmbH	accessdata.fda.gov
July 24, 2020	K200849	Tempus LS - Manual	LDD	Substantially Equivalent	Remote Diagnostic Technologies, Ltd. A Philips Company	accessdata.fda.gov
July 10, 2020	K200480	DreamStation 2 System, DreamStation 2 Advanced System	BZD	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
June 3, 2020	K200974	QLAB Advanced Quantification Software	QIH	Substantially Equivalent	Philips Health Care	accessdata.fda.gov
May 22, 2020	K200410	Reconnaissance PV .018 OTW Digital IVUS Catheter	OBJ	Substantially Equivalent	Philips Image Guided Therapy Corporation	accessdata.fda.gov
May 14, 2020	K201053	PercuNav Image Fusion and Interventional Navigation	JAK	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
May 4, 2020	K193228	Hamilton-G5	CBK	Substantially Equivalent	Hamilton Medical AG	accessdata.fda.gov
May 1, 2020	K201012	EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
April 16, 2020	K192875	Philips Biosensor BX100	DRG	Substantially Equivalent	Philips Medical Systems	accessdata.fda.gov
March 26, 2020	K192886	OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip	DQX	Substantially Equivalent	Volcano Corporation	accessdata.fda.gov
March 6, 2020	K200304	EPIQ Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
February 18, 2020	K200179	Collaboration Live	LLZ	Substantially Equivalent	Philips Health Care	accessdata.fda.gov
January 24, 2020	K193454	IQon Spectral CT	JAK	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
December 27, 2019	K193403	UroNav System	LLZ	Substantially Equivalent	Invivo Corporation	accessdata.fda.gov
December 20, 2019	K191647	QLAB Advanced Quantification Software	QIH	Substantially Equivalent	Philips Health Care	accessdata.fda.gov
November 19, 2019	K182979	IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3	MHX	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
October 27, 2019	K190624	EarlyVue VS30	DSJ	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
October 9, 2019	K192200	DynaCAD	LLZ	Substantially Equivalent	Invivo Corporation	accessdata.fda.gov
September 6, 2019	K192226	Lumify Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Health Care	accessdata.fda.gov
August 6, 2019	K183387	M3290B Patient Information Center iX	MHX	Substantially Equivalent	Philips Medical Systems	accessdata.fda.gov
August 2, 2019	K181216	HAMILTON-T1, HAMILTON-C1	CBK	Substantially Equivalent	Hamilton Medical AG	accessdata.fda.gov
July 18, 2019	K181170	Trilogy Evo Universal	CBK	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
July 18, 2019	K181166	Trilogy Evo	CBK	Substantially Equivalent	Respironics, Inc.	accessdata.fda.gov
June 18, 2019	K190913	QLAB Advanced Quantification Software 13	LLZ	Substantially Equivalent	Philips Health Care	accessdata.fda.gov
June 4, 2019	K190461	Achieva 1.5T, 3.0T and Intera 1.5T MR Systems	LNH	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
April 26, 2019	K182637	Philips IntelliVue XDS Software	MSX	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
March 19, 2019	K180098	SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1	CBK	Substantially Equivalent	Maquet Critical Care AB	accessdata.fda.gov
February 11, 2019	K190078	IntraSight	DSA	Substantially Equivalent	Volcano Corporation	accessdata.fda.gov
January 11, 2019	K182973	DigitalDiagnost C90	MQB	Substantially Equivalent	Philips Medical Systems Dmc GmbH	accessdata.fda.gov
December 31, 2018	K183101	Zenition 50	OWB	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
December 6, 2018	K183040	Zenition 70	OWB	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
November 15, 2018	K181831	IntelliVue Multi-Measurement Module MMX	MHX	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
November 9, 2018	K182857	EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
October 23, 2018	K182529	Xperius Ultrasound System	IYN	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
October 19, 2018	K182561	UroNav (Version 3.0)	LLZ	Substantially Equivalent	Invivo Corporation	accessdata.fda.gov
September 10, 2018	K173941	IntelliSpace Perinatal Rev.K.00	HGM	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
July 27, 2018	K181485	EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
July 24, 2018	K180017	MX40 Release C.01	MHX	Substantially Equivalent	Philips Medical Systems	accessdata.fda.gov
July 16, 2018	K180534	Philips IntelliVue GuardianSoftware	DXJ	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
June 7, 2018	K181264	QLAB Advanced Quantification Software	LLZ	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
June 5, 2018	K180608	Lunoa System	MYB	Substantially Equivalent	Nightbalance BV	accessdata.fda.gov
February 5, 2018	K173433	ProxiDiagnost N90	OWB	Substantially Equivalent	Philips Medical Systems Dmc GmbH	accessdata.fda.gov
December 26, 2017	K172904	IntelliVue Capnography Extension, IntelliVue Microstream Extension	CCK	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
December 13, 2017	K172056	InnoSight Diagnostic Ultrasound System	IYO	Substantially Equivalent	Qisda Corporation	accessdata.fda.gov
November 9, 2017	K172226	MX40 Release B.07	MHX	Substantially Equivalent	Philips Medical Systems	accessdata.fda.gov
November 9, 2017	K171850	Philips CT Big Bore	JAK	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.	accessdata.fda.gov
November 2, 2017	K170853	InnoSpire Go	CAF	Substantially Equivalent	Respironics Respiratory Drug Delivery (Uk) , Ltd.	accessdata.fda.gov
October 6, 2017	K172406	Ingenuity TF	KPS	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.	accessdata.fda.gov
October 6, 2017	K171801	IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable	MHX	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
October 4, 2017	K172607	Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Health Care	accessdata.fda.gov
August 2, 2017	K162832	731 Series Ventilators	CBK	Substantially Equivalent	ZOLL Medical Corporation	accessdata.fda.gov
July 27, 2017	K171423	Nasal Alar SpO2 Sensor	DQA	Substantially Equivalent	Xhale, Inc.	accessdata.fda.gov
July 7, 2017	K163584	M3290B Philips IntelliVue Information Center iX	MHX	Substantially Equivalent	Philips Medical Systems	accessdata.fda.gov
May 30, 2017	K171314	QLAB Advanced Quantification Software	LLZ	Substantially Equivalent	Philips Health Care	accessdata.fda.gov
April 21, 2017	K170716	PercuNav Image Fusion and Interventional Navigation	JAK	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
April 7, 2017	K170059	Spectranetics Turbo-Elite Laser Atherectomy Catheters	MCW	Substantially Equivalent	Spectranetics, Inc.	accessdata.fda.gov
January 31, 2017	K163210	Philips CombiDiagnost R90	JAA	Substantially Equivalent	Philips Medical Systems Dmc GmbH	accessdata.fda.gov
January 27, 2017	K161767	Philips IntelliVue GuardianSoftware	DXJ	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov
January 10, 2017	K163120	EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
December 28, 2016	K162675	Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter	DQA	Substantially Equivalent	Masimo Corporation	accessdata.fda.gov
December 2, 2016	K162418	Pioneer Plus Catheter	PDU	Substantially Equivalent	Philips Volcano	accessdata.fda.gov
November 16, 2016	K163020	Xperius Ultrasound System	IYN	Substantially Equivalent	Philips Health Care	accessdata.fda.gov
November 7, 2016	K162863	dS Small Extremity 16CH 1.5T Coil	MOS	Substantially Equivalent	Invivo Therapeutics Corporation	accessdata.fda.gov
October 26, 2016	K160583	REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip	OBJ	Substantially Equivalent	Volcano Corporation	accessdata.fda.gov
October 3, 2016	K162549	Lumify Ultrasound System	IYN	Substantially Equivalent	Philips Health Care	accessdata.fda.gov
September 20, 2016	K161887	Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip	DQX	Substantially Equivalent	Volcano Corporation	accessdata.fda.gov
September 14, 2016	K162329	CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Health Care	accessdata.fda.gov
September 14, 2016	K162177	dS FootAnkle I6CH 1.5T Coil	MOS	Substantially Equivalent	Invivo Corporation	accessdata.fda.gov
August 31, 2016	K162001	1.5T and 3.0T 16 CH GE Shoulder Coils	MOS	Substantially Equivalent	Invivo Corporation	accessdata.fda.gov
August 8, 2016	K160743	Philips Ingenuity CT	JAK	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.	accessdata.fda.gov
July 1, 2016	K161531	IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800	MHX	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
May 11, 2020	P180028	HeartStart FRx Defibrillator	MKJ	19	May 21, 2026	accessdata.fda.gov
May 11, 2020	P160028	Philips HeartStart FR3 Defibrillator	MKJ	7	May 21, 2026	accessdata.fda.gov
June 6, 2019	P160029	HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)	NSA	26	February 2, 2026	accessdata.fda.gov
January 8, 2007	P050018	ANGIOSCULPT SCORING BALLOON CATHETER	NWX	32	April 4, 2025	accessdata.fda.gov
December 9, 1997	P960042	SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH	MFA	67	December 18, 2025	accessdata.fda.gov

Compare with other makers

Updated May 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.