Medical device makers in Australia: 161 FDA-registered establishments

Name: FDA-registered medical device makers in Australia
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

161 establishments in Australia are registered with the FDA to make medical devices for the US market, listing 507 device types. 81 have a 510(k) clearance or PMA approval on file and 11 have a recall event. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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Device types made here

Device types with the most registered makers in this country.

Device	Product code	Makers
System, Image Processing, Radiological	LLZ	13
Orthopedic Manual Surgical Instrument	LXH	7
Orthopedic Stereotaxic Instrument	OLO	6
Automated Radiological Image Processing Software	QIH	6
Medical Device Data System	OUG	5
Instrument, Manual, Surgical, General Use	MDM	4
Tape And Bandage, Adhesive	KGX	4
Instrument, Ent Manual Surgical	LRC	4
Screw, Fixation, Bone	HWC	3
Bit, Drill	HTW	3
Plate, Fixation, Bone	HRS	3
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	3
Tray, Surgical, Instrument	FSM	3
Impactor	HWA	3
Ventilator, Non-Continuous (Respirator)	BZD	3
System, Measurement, Blood-Pressure, Non-Invasive	DXN	3
Orthosis, Limb Brace	IQI	3
Container, Sharps	MMK	3
Implant, Cochlear	MCM	3
Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification	PGQ	3
Implant, Auditory Brainstem	MHE	3
Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring	SEM	3
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	KWS	2
Laparoscope, General & Plastic Surgery	GCJ	2
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	LZO	2
Shoulder Prosthesis, Reverse Configuration	PHX	2
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	MEH	2
Slide Stainer, Automated	KPA	2
Immunohistochemistry Reagents And Kits	NJT	2
Instrumentation For Clinical Multiplex Test Systems	NSU	2
Reagents, Specific, Analyte	MVU	2
Instrument, Ligature Passing And Knot Tying	HCF	2
Powered Laser Surgical Instrument	GEX	2
Accessories, Implant, Dental, Endosseous	NDP	2
Transducer, Ultrasonic, Diagnostic	ITX	2
Filters, Cell Collection, Tissue Processing	KET	2
Applicator, Absorbent Tipped, Non-Sterile	KXF	2
Needle, Suturing, Disposable	GAB	2
Cuff, Nerve	JXI	2
Accessory, Assisted Reproduction	MQG	2
Tray, Impression, Preformed	EHY	2
Massager, Therapeutic, Electric	ISA	2
Punch, Surgical	LRY	2
Awl	HWJ	2
Ventilator, Continuous, Facility Use	CBK	2
Mask, Gas, Anesthetic	BSJ	2
Cannula, Nasal, Oxygen	CAT	2
Retractor, Self-Retaining	FFO	2
Osteotome	HWM	2
Probe And Director, Gastro-Urology	FGM	2
Speculum, Ent	EPY	2
Cable, Electrode	IKD	2
Light, Examination, Medical, Battery Powered	KYT	2
Retainer, Surgical	GCZ	2
Forceps, Biopsy, Non-Electric	FCL	2
Computer, Blood-Pressure	DSK	2
Joint, Knee, External Brace	ITQ	2
Cleaner, Ultrasonic, Medical Instrument	FLG	2
Disinfectant, Medical Devices	LRJ	2
Device, Anti-Snoring	LRK	2
Hammer, Surgical	FZY	2
Sunglasses (Non-Prescription Including Photosensitive)	HQY	2
Orthopedic Tray	OJH	2
Resin, Denture, Relining, Repairing, Rebasing	EBI	2
Maintainer, Space Preformed, Orthodontic	DYT	2
Eraser, Dental Stain	MAU	2
Applicator, Resin	KXR	2
Plethysmograph, Impedance	DSB	2
Shoulder Arthroplasty Implantation System	QHE	2
Source, Carrier, Fiberoptic Light	EQH	2
System, Digital Image Communications, Radiological	LMD	2
System, Multipurpose For In Vitro Coagulation Studies	JPA	2
Bandage, Liquid, Skin Protectant	NEC	2
Ventilatory Effort Recorder	MNR	2
Reduced- Montage Standard Electroencephalograph	OMC	2
Ventilator, Continuous, Non-Life-Supporting	MNS	2
Wheelchair, Powered	ITI	2
Perimeter, Automatic, Ac-Powered	HPT	2
Setter, Band, Orthodontic	ECR	2
Protector, Dental	BRW	2
System, Automated Platelet Aggregation	JOZ	2
Detectors And Removers, Lice, (Including Combs)	LJL	2
Active Implantable Bone Conduction Hearing System	PFO	2
Instrument, Biopsy, Suction	FCK	2
Microbial Colony Image Assessment System	PPU	2
Light, Lymphedema Reduction, Low Energy	NZY	2
Pin, Fixation, Smooth	HTY	1
Washer, Bolt Nut	HTN	1
Apparatus, Traction, Non-Powered	HST	1
Accessories, Arthroscopic	NBH	1
Appliance, Fixation, Spinal Intervertebral Body	KWQ	1
Orthosis, Spondylolisthesis Spinal Fixation	MNH	1
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	LPH	1
Orthosis, Spinal Pedicle Fixation	MNI	1
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	1
Spinal Vertebral Body Replacement Device	MQP	1
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	HSX	1
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	JDI	1
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	JWH	1

Makers in Australia

Best documented first: most 510(k) clearances and PMA approvals.

Maker	Location	Device types	510(k) clearances	PMA approvals	Recall events	Source
Resmed Pty Ltd.	BELLA VISTA New South Wales, Australia	18	64	0	5	api.fda.gov
Signature Orthopaedics Pty Limited	Sydney New South Wales, Australia	40	49	0	3	api.fda.gov
Sdi Ltd.	BAYSWATER Victoria, Australia	16	32	0	1	api.fda.gov
Compumedics Limited	Melbourne Victoria, Australia	12	14	0	0	api.fda.gov
Impedimed Limited	Lindfield New South Wales, Australia	4	12	0	1	api.fda.gov
Cochlear Ltd	Macquarie University New South Wales, Australia	7	6	5	0	api.fda.gov
Adherium Limited	Victoria, Australia	1	10	0	0	api.fda.gov
Ellex Medical Pty Ltd	Mawson Lakes South Australia, Australia	5	10	0	4	api.fda.gov
Kico Knee Innovation Company	Frenchs Forest New South Wales, Australia	10	10	0	3	api.fda.gov
4dmedical Limited	Carlton Victoria, Australia	4	9	0	0	api.fda.gov
Harrison-AI Medical Pty Ltd	Sydney New South Wales, Australia	2	9	0	0	api.fda.gov
Somnomed, Ltd.	CROWS NEST New South Wales, Australia	5	9	0	0	api.fda.gov
Implant Solutions Pty Ltd (trading AS Osteon Medical)	Mulgrave Victoria, Australia	8	8	0	0	api.fda.gov
William A. Cook Australia Pty, Ltd.	EIGHT MILE PLAINS Queensland, Australia	4	7	1	0	api.fda.gov
Cochlear Limited - Brisbane	Newstead Queensland, Australia	6	2	5	0	api.fda.gov
Resonance Health Analysis Services Pty Ltd	Burswood Western Australia, Australia	4	7	0	0	api.fda.gov
ATCOR MEDICAL Pty Ltd	SYDNEY New South Wales, Australia	3	6	0	0	api.fda.gov
GENEA BIOMEDX Pty Ltd.	Sydney New South Wales, Australia	4	6	0	0	api.fda.gov
Magic Mobility	Scoresby Victoria, Australia	2	6	0	0	api.fda.gov
Nanosonics Limited	Macquarie Park New South Wales, Australia	5	6	0	0	api.fda.gov
Optimized Ortho Pty Ltd	Sydney New South Wales, Australia	7	6	0	0	api.fda.gov
Cochlear Ltd.	LANE COVE New South Wales, Australia	6	0	5	0	api.fda.gov
Go Medical Industries Pty. Ltd.	SUBIACO Western Australia, Australia	6	5	0	1	api.fda.gov
The O R Company Pty Ltd	Cheltenham Victoria, Australia	11	5	0	0	api.fda.gov
Care Essentials Pty Ltd	North Geelong Victoria, Australia	2	4	0	1	api.fda.gov
Field Orthopaedics	Teneriffe Queensland, Australia	11	4	0	0	api.fda.gov
Open Airway Dental Solutions Australia Pty Ltd	Taringa Queensland, Australia	2	4	0	0	api.fda.gov
Gelflex Laboratories	PERTH Western Australia, Australia	3	3	0	0	api.fda.gov
GKC Manufacturing Pty Ltd	Melbourne Victoria, Australia	3	3	0	0	api.fda.gov
Micropace Pty. Ltd.	Homebush West New South Wales, Australia	3	3	0	0	api.fda.gov
Omniscient Neurotechnology Pty Ltd (o8t)	Haymarket New South Wales, Australia	2	3	0	0	api.fda.gov
Polynovo Biomaterials Pty Ltd	Port Melbourne Victoria, Australia	1	3	0	0	api.fda.gov
See-Mode Technologies Pty Ltd	Melbourne Victoria, Australia	3	3	0	0	api.fda.gov
Artrya	Perth Western Australia, Australia	3	2	0	0	api.fda.gov
Asiga	Alexandria New South Wales, Australia	6	2	0	0	api.fda.gov
Cathrx	Rydalmere New South Wales, Australia	2	2	0	0	api.fda.gov
Clever Culture Systems Limited	Adelaide South Australia, Australia	2	2	0	0	api.fda.gov
Daniels Corporation International Pty Ltd	Dandenong South Victoria, Australia	2	2	0	0	api.fda.gov
Dorsavi Ltd	Oakleigh South Victoria, Australia	3	2	0	0	api.fda.gov
Enterix Pty Ltd.	NORTH RYDE New South Wales, Australia	2	2	0	0	api.fda.gov
Fink Engineering Pty Ltd	Laverton North Victoria, Australia	1	2	0	0	api.fda.gov
Imaxeon Pty Ltd	Rydalmere New South Wales, Australia	2	2	0	0	api.fda.gov
Micro-X Ltd	Tonsley South Australia, Australia	2	2	0	8	api.fda.gov
Navbit Pty Ltd	South Eveleigh New South Wales, Australia	2	2	0	0	api.fda.gov
Orthocell Limited	Perth Western Australia, Australia	2	2	0	0	api.fda.gov
Qlicksmart Pty., Ltd.	WEST END, BRISBANE Queensland, Australia	5	2	0	0	api.fda.gov
Singular Health Pty Ltd	Leederville Western Australia, Australia	1	2	0	0	api.fda.gov
Uscom Limited	SYDNEY New South Wales, Australia	4	2	0	0	api.fda.gov
Actis Medical	Torrensville South Australia, Australia	6	1	0	0	api.fda.gov
Akunah	Brisbane Queensland, Australia	1	1	0	0	api.fda.gov
Asp Plastics Pty Ltd.	ST-MARYS New South Wales, Australia	1	1	0	0	api.fda.gov
Atmo Biosciences Ltd	Box Hill Victoria, Australia	1	1	0	0	api.fda.gov
Aus Systems Pty Ltd.	ALLENBY GARDENS South Australia, Australia	2	1	0	0	api.fda.gov
Anteris Aus Operations Pty Ltd	Malaga Western Australia, Australia	1	1	0	0	api.fda.gov
Better Breathing Devices Pty Ltd	Tweed Heads South New South Wales, Australia	1	1	0	0	api.fda.gov
Concourse Assistive Technology Pty Ltd	Wetherill Park New South Wales, Australia	1	1	0	0	api.fda.gov
Cyclomedica Australia Pty Ltd	Kingsgrove New South Wales, Australia	1	1	0	0	api.fda.gov
Echoiq Limited	Sydney New South Wales, Australia	1	1	0	0	api.fda.gov
Epiminder Limited	Melbourne Victoria, Australia	1	1	0	0	api.fda.gov
Genetic Signatures Limited	Newtown New South Wales, Australia	4	1	0	0	api.fda.gov
Gyder Surgical Pty Ltd	Mulgrave Victoria, Australia	2	1	0	0	api.fda.gov
Headsafe MFG Pty Ltd	Surry Hills New South Wales, Australia	2	1	0	0	api.fda.gov
IBD Medical Trading Pty Ltd.	Ultimo New South Wales, Australia	5	1	0	0	api.fda.gov
Incisive Technologies Pty Ltd	Ferntree Gully Victoria, Australia	1	1	0	0	api.fda.gov
Livac Pty Ltd	Hawthorn Victoria, Australia	1	1	0	0	api.fda.gov
Mano And Mano Pty Ltd	Moorabbin Airport Victoria, Australia	1	1	0	0	api.fda.gov
Medical Developments International	Scoresby Victoria, Australia	2	1	0	0	api.fda.gov
Myofunctional Research Corp. Pty. Ltd.	HELENSVALE Queensland, Australia	5	1	0	0	api.fda.gov
Navi Medical Technologies Pty Ltd	Carlton Victoria, Australia	1	1	0	0	api.fda.gov
Norseld Pty. Ltd.	ADELAIDE South Australia, Australia	1	1	0	0	api.fda.gov
Orecchio Pty Ltd.	Subiaco Western Australia, Australia	1	1	0	0	api.fda.gov
PainChek Ltd.	Sydney New South Wales, Australia	1	1	0	0	api.fda.gov
Renerve Ltd	Melbourne Victoria, Australia	1	1	0	0	api.fda.gov
Riancorp Pty Ltd	Henley Beach South Australia, Australia	1	1	0	0	api.fda.gov
Stratos Medtech Pty Ltd	Maryborough Queensland, Australia	1	1	0	0	api.fda.gov
Sydney Neuroimaging Analysis Centre Pty Ltd	Camperdown New South Wales, Australia	3	1	0	0	api.fda.gov
Saluda Medical Pty. Ltd.	Macquarie Park New South Wales, Australia	3	0	1	0	api.fda.gov
Trewavis Surgical Instruments Pty Ltd.	Bayswater Victoria, Australia	3	1	0	0	api.fda.gov
Voyager Imaging	Hawthorn East Victoria, Australia	1	1	0	0	api.fda.gov
Vitasora Health Limited	Melbourne Victoria, Australia	1	1	0	0	api.fda.gov
Zed Technologies	Melbourne Victoria, Australia	1	1	0	0	api.fda.gov
1922 Pty Ltd	Marrickville New South Wales, Australia	2	0	0	0	api.fda.gov
Aeris Environmental Ltd	Rosebery New South Wales, Australia	4	0	0	0	api.fda.gov
Axxin Pty Ltd	Eaglemont Victoria, Australia	1	0	0	0	api.fda.gov
Bandicool	Middle Park Victoria, Australia	1	0	0	0	api.fda.gov
Baxter Laboratories	Boronia Victoria, Australia	1	0	0	0	api.fda.gov
Better Balance Orthotics	Castle Hill New South Wales, Australia	1	0	0	0	api.fda.gov
Brooks Laboratory Automation Solutions PTY LTD	VIRGINIA, Queensland, Australia	1	0	0	0	api.fda.gov
Chewly Pty. Ltd.	Bellfield Victoria, Australia	2	0	0	0	api.fda.gov
CT Healthcare Pty Ltd trading as Niagara Therapy	Parkinson Queensland, Australia	1	0	0	0	api.fda.gov
Daizo Eyewear Pty Ltd	Brighton Victoria, Australia	5	0	0	0	api.fda.gov
Denneroll Industries International Pty Ltd	CROMER New South Wales, Australia	1	0	0	0	api.fda.gov
Diag-Nose Medical Pty Ltd	Notting Hill Victoria, Australia	1	0	0	0	api.fda.gov
Ellapack Pty Ltd	Keysborough Victoria, Australia	1	0	0	0	api.fda.gov
Eoca MD Pty Limited	Double Bay New South Wales, Australia	4	0	0	0	api.fda.gov
Erskine Dental	MACKSVILLE New South Wales, Australia	12	0	0	0	api.fda.gov
Evolve MVMT Pty Ltd	Melbourne Victoria, Australia	1	0	0	0	api.fda.gov
Eyeonic Pty Limited	Caulfield North Victoria, Australia	1	0	0	0	api.fda.gov
Ferno Australia	Brendale Queensland, Australia	2	0	0	0	api.fda.gov
Gropep Bioreagents Pty Ltd	Adelaide South Australia, Australia	1	0	0	0	api.fda.gov
Healthtec Pty Ltd	Wacol Queensland, Australia	2	0	0	0	api.fda.gov
Inka Surgical Instruments	Jandakot Western Australia, Australia	139	0	0	0	api.fda.gov
Innovation Scientific Pty Ltd	Vineyard New South Wales, Australia	23	0	0	0	api.fda.gov
Innovgas Pty Ltd	Docklands Victoria, Australia	2	0	0	0	api.fda.gov
International Medical Research	Balcatta Western Australia, Australia	1	0	0	0	api.fda.gov
Iorthotics Pty Ltd	Windsor Queensland, Australia	1	0	0	0	api.fda.gov
Icon Plastics Pty Ltd	Hallam Victoria, Australia	4	0	0	0	api.fda.gov
Imaging Solutions (AU)	Park Ridge Queensland, Australia	4	0	0	0	api.fda.gov
Invetech Pty Ltd	Mount Waverley Victoria, Australia	5	0	0	0	api.fda.gov
Kailo Medical Pty Ltd	Hawthorn Victoria, Australia	1	0	0	0	api.fda.gov
Labworks Australia Pty Ltd	Ferntree Gully Victoria, Australia	1	0	0	0	api.fda.gov
Laronix Pty Ltd	Brisbane City Queensland, Australia	2	0	0	0	api.fda.gov
Leica Biosystems Melbourne Pty Ltd	MELBOURNE Victoria, Australia	9	0	0	1	api.fda.gov
Lenexa Medical Pty Ltd	Balwyn Victoria, Australia	1	0	0	0	api.fda.gov
Mac Surgical	Brookvale New South Wales, Australia	4	0	0	0	api.fda.gov
Macquarie Medical Systems Pvt. Ltd	Leichhardt New South Wales, Australia	1	0	0	0	api.fda.gov
Matana Pty Ltd	POINT COOK, Victoria, Australia	2	0	0	0	api.fda.gov
Maxm Skate Pty Ltd	Torrensville South Australia, Australia	1	0	0	0	api.fda.gov
Medical Manufacturers	MT. WAVERLEY Victoria, Australia	1	0	0	0	api.fda.gov
Medmont International Pty Ltd	Nunawading Victoria, Australia	3	0	0	0	api.fda.gov
Modibodi Pty Ltd	Sydney New South Wales, Australia	2	0	0	0	api.fda.gov
Moregate Exports Pty Ltd	brisbane Queensland, Australia	1	0	0	0	api.fda.gov
Myo Munchee (operations) Pty Ltd	Carrington New South Wales, Australia	1	0	0	0	api.fda.gov
Modsel Pty Ltd	MARYBOROUGH Queensland, Australia	1	0	0	0	api.fda.gov
Nutricare Pty Ltd	Melbourne Victoria, Australia	2	0	0	0	api.fda.gov
Novapharm Research Australia Pty Ltd	Rosebery New South Wales, Australia	1	0	0	0	api.fda.gov
Oxoid Australia Pty Limited	THEBARTON South Australia, Australia	7	0	0	1	api.fda.gov
Osseointegration International Pty Ltd	Macquarie Park New South Wales, Australia	3	0	0	0	api.fda.gov
Para Mobility Pty Ltd	Dural New South Wales, Australia	1	0	0	0	api.fda.gov
Permanence Wholesale Pty Ltd	Sydney New South Wales, Australia	1	0	0	0	api.fda.gov
Planet Innovation	Box Hill Victoria, Australia	3	0	0	0	api.fda.gov
POD Active Pty Ltd	Geelong Victoria, Australia	3	0	0	0	api.fda.gov
PPC Moulding Services Pty Ltd	Villawood New South Wales, Australia	2	0	0	0	api.fda.gov
Precision Ai Pty Ltd	Brisbane Queensland, Australia	3	0	0	0	api.fda.gov
Relax Retractors	Kingswood New South Wales, Australia	2	0	0	0	api.fda.gov
Rhinomed Limited	Cremorne Victoria, Australia	3	0	0	0	api.fda.gov
Riha Industries Pty Ltd	Edinburgh North South Australia, Australia	1	0	0	0	api.fda.gov
Sabre Medical Pty Ltd	Lane Cove West New South Wales, Australia	3	0	0	0	api.fda.gov
Safestyle Holdings Pty Ltd	Osborne Park Western Australia, Australia	1	0	0	0	api.fda.gov
Scan Optics Pty., Ltd.	THEBARTON, ADELAIDE South Australia, Australia	3	0	0	0	api.fda.gov
Schott Minifab Pty Ltd	Scoresby Victoria, Australia	1	0	0	0	api.fda.gov
Scolicare	Kogarah New South Wales, Australia	1	0	0	0	api.fda.gov
Si&d (aust) Pty Ltd	Norwest New South Wales, Australia	2	0	0	0	api.fda.gov
Sienna Cancer Diagnostics Limited	Melbourne Victoria, Australia	2	0	0	0	api.fda.gov
Speedx Pty Ltd	Eveleigh New South Wales, Australia	1	0	0	0	api.fda.gov
SRC Health Pty Ltd.	Port Melbourne Victoria, Australia	1	0	0	0	api.fda.gov
Srxglobal (australia) Pty Ltd	Dandenong Victoria, Australia	1	0	0	0	api.fda.gov
Strapit Medical And Sports Supplies	Thomastown Victoria, Australia	6	0	0	0	api.fda.gov
Survival Services Pty Ltd T/A SURVIVAL EMERGENCY SOLUTIONS	Green Point New South Wales, Australia	2	0	0	0	api.fda.gov
Telscope Systems	Castle Hill New South Wales, Australia	2	0	0	0	api.fda.gov
Tolife Technologies Pty Ltd	Welshpool Western Australia, Australia	3	0	0	0	api.fda.gov
Trajan Scientific Australia Pty Ltd	Ringwood Victoria, Australia	7	0	0	0	api.fda.gov
Tresmine Pty Ltd T/A Circuitwise Electronics	Bella vista New South Wales, Australia	2	0	0	0	api.fda.gov
The Natural Patch Company Pty Ltd	Prahran Victoria, Australia	1	0	0	0	api.fda.gov
United Pacific Industries Pty. Ltd.	KILSYTH Victoria, Australia	4	0	0	0	api.fda.gov
Vald Performance (usa) Pty Ltd	Newstead Queensland, Australia	1	0	0	0	api.fda.gov
Vito Health Pty Ltd	CARLTON Victoria, Australia	1	0	0	0	api.fda.gov
Vorotek	Moolap Victoria, Australia	5	0	0	0	api.fda.gov
Vitrafy Laboratory and Manufacturing Centre	Wendouree Victoria, Australia	1	0	0	0	api.fda.gov
W&S Plastics Pty Ltd	Moorebank New South Wales, Australia	2	0	0	0	api.fda.gov
Whiteley Corporation Pty Ltd	Tomago New South Wales, Australia	1	0	0	0	api.fda.gov

Updated November 2, 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.