Medical device makers in Brazil: 105 FDA-registered establishments

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

105 establishments in Brazil are registered with the FDA to make medical devices for the US market, listing 455 device types. 49 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 3, 2026.

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Device types made here

Device types with the most registered makers in this country.

Device	Product code	Makers
Accessories, Implant, Dental, Endosseous	NDP	8
Tray, Surgical, Instrument	FSM	8
Retractor, All Types	EIG	7
Instrument, Manual, Surgical, General Use	MDM	6
Strip, Polishing Agent	EHM	6
Agent, Polishing, Abrasive, Oral Cavity	EJR	6
Positioner, Tooth, Preformed	KMY	6
Orthopedic Manual Surgical Instrument	LXH	5
Implant, Endosseous, Root-Form	DZE	5
Cannula, Surgical, General & Plastic Surgery	GEA	5
Handle, Instrument, Dental	EJB	5
Instruments, Dental Hand	DZN	5
Floss, Dental	JES	5
Wire, Orthodontic	DZC	5
Tube, Orthodontic	DZD	5
Abutment, Implant, Dental, Endosseous	NHA	4
Powered Laser Surgical Instrument	GEX	4
Retractor	GAD	4
Point, Abrasive	EHL	4
Tray, Impression, Preformed	EHY	4
Toothbrush, Manual	EFW	4
Instrument, Ligature Tucking, Orthodontic	ECP	4
Tray, Surgical	LRP	4
Drill, Dental, Intraoral	DZA	4
Crown And Bridge, Temporary, Resin	EBG	4
Resin, Denture, Relining, Repairing, Rebasing	EBI	4
Bracket, Metal, Orthodontic	EJF	4
Band, Elastic, Orthodontic	ECI	4
Spring, Orthodontic	ECO	4
Accessories, Arthroscopic	NBH	3
Forceps, General & Plastic Surgery	GEN	3
Bur, Dental	EJL	3
Scissors, General, Surgical	LRW	3
File, Pulp Canal, Endodontic	EKS	3
Forceps	HTD	3
Lamp, Infrared, Therapeutic Heating	ILY	3
Pusher, Band, Orthodontic	ECS	3
Gauge, Depth, Instrument, Dental	EIL	3
Unit, Operative Dental	EIA	3
Sunglasses (Non-Prescription Including Photosensitive)	HQY	3
Instrument, Manual, General Obstetric-Gynecologic	KOH	3
Material, Tooth Shade, Resin	EBF	3
Post, Root Canal	ELR	3
Denture, Plastic, Teeth	ELM	3
Disk, Abrasive	EHJ	3
Lamp, Surgical	FTD	3
Frame, Spectacle	HQZ	3
Lens, Spectacle, Non-Custom (Prescription)	HQG	3
Dam, Rubber	EIE	3
Clamp, Wire, Orthodontic	ECN	3
Facebow	KCR	3
Spirometer, Monitoring (W/Wo Alarm)	BZK	3
Retainer, Screw Expansion, Orthodontic	DYJ	3
Band, Material, Orthodontic	DYO	3
Bracket, Ceramic, Orthodontic	NJM	3
Screw, Fixation, Bone	HWC	2
Washer, Bolt Nut	HTN	2
Blade, Saw, General & Plastic Surgery, Surgical	GFA	2
Bit, Drill	HTW	2
Plate, Fixation, Bone	HRS	2
Thoracolumbosacral Pedicle Screw System	NKB	2
Screw, Fixation, Intraosseous	DZL	2
Rod, Fixation, Intramedullary And Accessories	HSB	2
Accessory, Surgical Apparel	LYU	2
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2
Needle, Hypodermic, Single Lumen	FMI	2
Instrument, Ligature Passing And Knot Tying	HCF	2
Device, Monitoring, Intracranial Pressure	GWM	2
Applicator, Absorbent Tipped, Sterile	KXG	2
Culture Media, Non-Selective And Non-Differential	JSG	2
Cannula, Injection	FGY	2
Hook, Surgical, General & Plastic Surgery	GDG	2
Needle, Aspiration And Injection, Disposable	GAA	2
Instruments, Surgical, Cardiovascular	DWS	2
Tape And Bandage, Adhesive	KGX	2
Template	HWT	2
Depressor, Tongue, Non-Surgical	FMA	2
Motor, Surgical Instrument, Ac-Powered	GEY	2
Unit, Syringe, Air And/Or Water	ECB	2
Cup, Prophylaxis	EHK	2
Dispenser, Liquid Medication	KYX	2
Mouthpiece, Saliva Ejector	DYN	2
Dressing, Wound, Hydrogel Without Drug And/Or Biologic	NAE	2
Chair, Dental, Without Operative Unit	NRU	2
Dressing, Wound, Occlusive	NAD	2
Massager, Therapeutic, Electric	ISA	2
Chisel, Bone, Surgical	EML	2
Instrument, Cutting, Operative	EKD	2
Holder, Needle, Gastroenterologic	FHQ	2
Plier, Orthodontic	JEX	2
Forceps, Rongeur, Surgical	EMH	2
Curette, Surgical, Dental	EMK	2
Probe	HXB	2
Instrument, Bending Or Contouring	HXP	2
Instrument, Compression	HWN	2
Elevator	HTE	2
Extractor	HWB	2
Instrument, Cutting, Orthopedic	HTZ	2
Stocking, Elastic	ILG	2
Retractor, Self-Retaining	FFO	2

Makers in Brazil

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

Maker	Location	Device types	510(k) clearances	PMA approvals	Recall events	Source
JJGC Industria e Comercio de Materiais Dentarios SA	Curitiba Parana, Brazil	21	57	0	2	api.fda.gov
S.I.N. Implant System Ltda	Sao Paulo, Brazil	5	22	0	2	api.fda.gov
GM Dos Reis Industria E Comercio Ltda	Campinas Sao Paulo, Brazil	21	21	0	0	api.fda.gov
Philips Medical Systems Ltda	Varginha Minas Gerais, Brazil	32	19	0	0	api.fda.gov
Greiner Bio One Brasil Produtos Medicos Hospitalar	AMERICANA Sao Paulo, Brazil	5	13	0	0	api.fda.gov
Angelus Industria De Productos Odontologicos	LONDRINA Parana, Brazil	21	11	0	0	api.fda.gov
Dentscare Ltda	Joinville Santa Catarina, Brazil	14	10	0	0	api.fda.gov
Alliage S/A Industrias Medico Odontologica	Ribeirao Preto Sao Paulo, Brazil	10	8	0	0	api.fda.gov
Vydence Medical Industria e Comercio Ltda	CEAT - Sao Carlos/SP Sao Paulo, Brazil	4	8	0	0	api.fda.gov
Ibramed Industria Brasileira de Equipamentos Medicos Ltda	Amparo Sao Paulo, Brazil	8	6	0	0	api.fda.gov
Neoortho Produtos Ortopedicos S/A	Curitiba Parana, Brazil	28	6	0	0	api.fda.gov
Osteomed Implantes	Rio Claro Sao Paulo, Brazil	7	4	0	0	api.fda.gov
Aditek Do Brasil, SA	CRAVINHOS Sao Paulo, Brazil	12	3	0	0	api.fda.gov
Braincare Desenvolvimento E Inovacao Tecnologica S.A.	Sao Carlos Sao Paulo, Brazil	1	3	0	0	api.fda.gov
Kolplast Ci Ltda	Itupeva Sao Paulo, Brazil	10	3	0	0	api.fda.gov
Timpel S.A.	Sao Paulo, Brazil	2	3	0	0	api.fda.gov
Timpel S.A.	Pato Branco Parana, Brazil	2	3	0	0	api.fda.gov
Agaplastic Ind. Com. Ltda.	Rio De Janeiro, Brazil	7	2	0	0	api.fda.gov
Dental Morelli Ltda.	SOROCABA Sao Paulo, Brazil	25	2	0	0	api.fda.gov
DMC Importacao E Exportacao De Equipamentos Ltda	Sao Carlos Sao Paulo, Brazil	4	2	0	0	api.fda.gov
Implacil De Bortoli Material Odontologico Ltda	Sao Paulo, Brazil	4	2	0	0	api.fda.gov
Medical San Industria De Equipamentos Medicos Ltda	Estrela Rio Grande do Sul, Brazil	3	2	0	0	api.fda.gov
Olsen Industria E Comercio S/A	Palhoca Santa Catarina, Brazil	7	2	0	0	api.fda.gov
Orthometric Ind. E Com. De Prod. Med. Odont.	Marilia Sao Paulo, Brazil	17	2	0	0	api.fda.gov
Phelcom Technologies	Sao Carlos Sao Paulo, Brazil	2	2	0	0	api.fda.gov
bioBoaVista	Valinhos Sao Paulo, Brazil	7	2	0	0	api.fda.gov
3R Industria E Comercio Ltda	Sao Paulo, Brazil	8	1	0	0	api.fda.gov
Ac Equipamentos Medicos E Odontologicos Ltda	Ribeirao Preto Sao Paulo, Brazil	3	1	0	0	api.fda.gov
Avanutri Equipamentos De Saude Ltda	Tres Rios Rio de Janeiro, Brazil	4	1	0	0	api.fda.gov
Becton Dickinson Ind. Cirurgicas Ltda.	CURITIBA Parana, Brazil	2	1	0	0	api.fda.gov
Becton Dickinson Industrias Cirurgicas, Ltda.	JUIZ DE FORA Minas Gerais, Brazil	2	1	0	0	api.fda.gov
Biomecanica Industria E Comercio De Produtos Ortopedicos Ltda	Jau Sao Paulo, Brazil	1	1	0	0	api.fda.gov
Blue Dent Dental	Pirassununga Sao Paulo, Brazil	2	1	0	0	api.fda.gov
BMR Medical	Campina Grande do Sul Parana, Brazil	1	1	0	0	api.fda.gov
D.S.P. Industrial Eireli Epp	Campo Largo Parana, Brazil	6	1	0	0	api.fda.gov
Dentsply Industria E Comercio Ltda	PIRASSUNUNGA Sao Paulo, Brazil	2	1	0	0	api.fda.gov
Evoden Industria Comercio Importacao E Exportacao De Produtos Odontologicos Ltda.	Pirassununga Sao Paulo, Brazil	4	1	0	0	api.fda.gov
Fabinject Industria E Comercio Importacao E Exportacao Ltda	Taubate Sao Paulo, Brazil	5	1	0	0	api.fda.gov
Global Tec Industria E Comercio De Produtos Medicos Ltda	Sao Paulo, Brazil	1	1	0	0	api.fda.gov
Ionic Health Technologies SA	Sao Jose dos Campos Sao Paulo, Brazil	4	1	0	0	api.fda.gov
Kenvue LTDA	Sao Jose dos Campos Sao Paulo, Brazil	2	1	0	0	api.fda.gov
LMG Lasers Comercio Importacao E Exportacao Ltda	Guaxupe Minas Gerais, Brazil	1	1	0	0	api.fda.gov
Magnamed Tecnologia Medica S/A	Sao Paulo, Brazil	3	1	0	0	api.fda.gov
Micromar Industria E Comercio Ltda	Serraria, Diadema Sao Paulo, Brazil	1	1	0	0	api.fda.gov
Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.	SAO CARLOS Sao Paulo, Brazil	5	1	0	0	api.fda.gov
Philips Clinical Informatics	Blumenau Santa Catarina, Brazil	2	1	0	0	api.fda.gov
Solotica Industria E Comercio Ltda	Sao Paulo, Brazil	2	1	0	0	api.fda.gov
St. Jude Medical Brasil Ltda.	Belo Horizonte Minas Gerais, Brazil	4	0	1	0	api.fda.gov
Vigodent Industria E Comercio Ltda	Rio de Janeiro, Brazil	3	1	0	0	api.fda.gov
Alacer Industria Eletronica Ltda	Sao Paulo, Brazil	3	0	0	0	api.fda.gov
Andre Gregate Braga Instrumentos Ltda	CAIEIRAS Sao Paulo, Brazil	1	0	0	0	api.fda.gov
Apramed Industria E Comercio De Aparelhos Medicos Ltda	SAO CARLOS Sao Paulo, Brazil	16	0	0	0	api.fda.gov
Atrasorb Industria De Produtos Hospitalares	Sao Roque Sao Paulo, Brazil	1	0	0	0	api.fda.gov
Barrfab Industria Comercio Importacao De Equipamentos Hospit	Farroupilha Rio Grande do Sul, Brazil	4	0	0	0	api.fda.gov
Baumer S.A.	MOGI MIRIM - SP Sao Paulo, Brazil	2	0	0	0	api.fda.gov
Bio-Art Equipamentos Odontologicos Ltda.	SAO CARLOS Sao Paulo, Brazil	7	0	0	0	api.fda.gov
Biotecno Industria E Comercio Ltda	SANTA ROSA Rio Grande do Sul, Brazil	1	0	0	0	api.fda.gov
Casex, Ltda	Curitiba Parana, Brazil	10	0	0	0	api.fda.gov
Colgate-Palmolive Industrial Ltda	Sao Paulo, Brazil	2	0	0	0	api.fda.gov
Condor Nordeste In E Com Ltda - Filial Sul	Sao Bento do Sul Santa Catarina, Brazil	2	0	0	0	api.fda.gov
Condor S.A	Sao Bento do Sul Santa Catarina, Brazil	2	0	0	0	api.fda.gov
Dentsply Industria E Comercio Ltda	PIRASSUNUNGA Sao Paulo, Brazil	3	0	0	0	api.fda.gov
DFL Industria E Comercio SA	Rio de Janeiro, Brazil	5	0	0	0	api.fda.gov
Easy Equipamentos Odontologicos Ltda	Belo Horizonte Minas Gerais, Brazil	1	0	0	0	api.fda.gov
Essity Do Brasil Industria E Comercio	Jarinu Sao Paulo, Brazil	1	0	0	0	api.fda.gov
Essilor Da Amazonia Industria E Comercio	Manaus Amazonas, Brazil	1	0	0	0	api.fda.gov
F & A Laboratorio Farmaceutico Ltda	Sao Paulo-SP, Brazil	2	0	0	0	api.fda.gov
Fabrica De Artefatos Metalurgicos Ita Ltda	Sao Caetano do Sul Sao Paulo, Brazil	1	0	0	0	api.fda.gov
Faga Medical Industria De Equipamentos E Instrumentos Medico Hospitalares Ltda Me	Bauru Sao Paulo, Brazil	8	0	0	0	api.fda.gov
Hanisch Medical Ltda	Portao Rio Grande do Sul, Brazil	2	0	0	0	api.fda.gov
Hidrolight Do Brasil SA	GAROPABA Santa Catarina, Brazil	9	0	0	0	api.fda.gov
Indrel Scientific	LONDRINA Parana, Brazil	1	0	0	0	api.fda.gov
Indusbello Industria De Instrumentos Odo	Londrina Parana, Brazil	11	0	0	0	api.fda.gov
Injemedic	VINHEDO Sao Paulo, Brazil	4	0	0	0	api.fda.gov
ITM Industria de Tecnologias Medicas LTDA	CANOAS Rio Grande do Sul, Brazil	45	0	0	0	api.fda.gov
Johnson & Johnson do Brasil Ind. Com. de Prod. p/ Saude Ltda	SAO JOSE DOS CAMPOS Sao Paulo, Brazil	4	0	0	0	api.fda.gov
Luxottica Brasil Produtos Oticos E Esportivos Ltda	CAMPINAS Sao Paulo, Brazil	3	0	0	0	api.fda.gov
Luxottica Brasil Produtos Oticos E Esportivos Ltda.	Jundiai Sao Paulo, Brazil	3	0	0	0	api.fda.gov
Maquira Industria De Produtos Odontologicos	Maringa Parana, Brazil	12	0	0	0	api.fda.gov
MB Industria Cirurgica Ltda	Paulista Pernambuco, Brazil	1	0	0	0	api.fda.gov
Medpej Equipamentos Medicos Ltda	Ribeirao Preto Sao Paulo, Brazil	4	0	0	0	api.fda.gov
Meta Moveis De Metais Industria E Comercio Ltda	Aparecida de Goiania Goias, Brazil	2	0	0	0	api.fda.gov
Nova Aventura Comercio De Artigos Esportivos Ltda	Campinas Sao Paulo, Brazil	2	0	0	0	api.fda.gov
Nutec Global Industria E Comercio Ltda	Rio Claro Sao Paulo, Brazil	1	0	0	0	api.fda.gov
Ortho Pauher Ind. Com. E Dist. Ltda	Recife Pernambuco, Brazil	17	0	0	0	api.fda.gov
PHS Do Brasil Ltda	Joinville Santa Catarina, Brazil	5	0	0	0	api.fda.gov
Rabbit Industria E Comercio De Produtos De Higiene Pessoal Ltda.	Londrina Parana, Brazil	4	0	0	0	api.fda.gov
Razek Equipamentos Ltda	Sao Carlos Sao Paulo, Brazil	4	0	0	0	api.fda.gov
Riellens Industria E Comercio Ltda	Vargem Grande Paulista Sao Paulo, Brazil	1	0	0	0	api.fda.gov
RP Conexoes Restauradoras Ltda	Caieiras Sao Paulo, Brazil	1	0	0	0	api.fda.gov
Schobell Industrial Ltda	Rio Claro Sao Paulo, Brazil	87	0	0	0	api.fda.gov
Sysmex Do Brasil Ind E Com Ltda	Sao Jose dos Pinhais Parana, Brazil	2	0	0	0	api.fda.gov
Sigvaris Do Brasil Ind. E Com. LTDA	Jundiai Sao Paulo, Brazil	2	0	0	0	api.fda.gov
TDV Dental Ltda	POMERODE Santa Catarina, Brazil	14	0	0	0	api.fda.gov
Tecnident Equipamentos Ortodonticos Ltda.	SAO CARLOS Sao Paulo, Brazil	9	0	0	0	api.fda.gov
Tecnocirurgica Comercio De Materiais Medicos Cirurgicos E Hospitalares Ltda	Rio Claro Sao Paulo, Brazil	14	0	0	0	api.fda.gov
Toyo Comercio Importacao E Exportacao De Instrumentos Cirurgicos Ltda	Sao Caetano do Sul Sao Paulo, Brazil	12	0	0	0	api.fda.gov
Trinity Biotech do Brasil	Extrema Minas Gerais, Brazil	2	0	0	0	api.fda.gov
Ultimate Do Brasil Importacao E Exportacao Ltda.	SAO JOSE DOS CAMPOS Sao Paulo, Brazil	4	0	0	0	api.fda.gov
Unidade De Esterilizacao Cotia Ltda.	Cotia Sao Paulo, Brazil	3	0	0	0	api.fda.gov
Visio Industria E Comercio De Equipamentos Ltda	Sao Paulo, Brazil	1	0	0	0	api.fda.gov
Volmed Brasil Equipamentos Ltda	Sao Carlos Sao Paulo, Brazil	3	0	0	0	api.fda.gov
Vuelo Pharma Ltda	Curitiba Parana, Brazil	1	0	0	0	api.fda.gov
Watanabe Equipamentos Medicos	Cravinhos, Sao Paulo, Brazil	1	0	0	0	api.fda.gov
Wise Comfort & Care Ltda	SAO CARLOS Sao Paulo, Brazil	2	0	0	0	api.fda.gov

Updated November 3, 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.