Medical device makers in Sweden: 188 FDA-registered establishments

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

188 establishments in Sweden are registered with the FDA to make medical devices for the US market, listing 470 device types. 97 have a 510(k) clearance or PMA approval on file and 27 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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SwedenCountry

Device types made here

Device types with the most registered makers in this country.

Device	Product code	Makers
Implant, Endosseous, Root-Form	DZE	7
Abutment, Implant, Dental, Endosseous	NHA	7
Accessories, Implant, Dental, Endosseous	NDP	7
System, Image Processing, Radiological	LLZ	7
Hearing Aid, Bone Conduction	LXB	7
Medical Device Data System	OUG	6
Instrument, Biopsy	KNW	6
Lift, Patient, Non-Ac-Powered	FSA	6
Aid, Transfer	IKX	5
Hearing Aid, Bone Conduction, Implanted	MAH	5
Dressing, Wound, Drug	FRO	4
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	4
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	KRR	4
Multi-Analyte Controls, All Kinds (Assayed)	JJY	4
Biopsy Needle	FCG	4
Handle, Instrument, Dental	EJB	4
Garment, Protective, For Incontinence	EYQ	4
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	4
Condenser, Heat And Moisture (Artificial Nose)	BYD	4
Instrument, Ent Manual Surgical	LRC	4
Post, Root Canal	ELR	4
Prosthesis, Nose, Internal	FZE	4
Walker, Mechanical	ITJ	4
Accessories, Wheelchair	KNO	4
Accelerator, Linear, Medical	IYE	4
Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees	PJY	4
Neurological Stereotaxic Instrument	HAW	3
Counter, Differential Cell	GKZ	3
Labware, Assisted Reproduction	MQK	3
Dressing, Wound, Hydrophilic	NAC	3
Guide, Needle, Surgical	GDF	3
Tape And Bandage, Adhesive	KGX	3
Instruments, Dental Hand	DZN	3
Evacuator, Oral Cavity	EHZ	3
Crown, Preformed	ELZ	3
Multi-Analyte Controls Unassayed	OHQ	3
Filter, Bacterial, Breathing-Circuit	CAH	3
Ventilator, Continuous, Facility Use	CBK	3
Chair, With Casters	INM	3
Sunglasses (Non-Prescription Including Photosensitive)	HQY	3
Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)	NHX	3
Chair, Adjustable, Mechanical	INN	3
Support, Head And Trunk, Wheelchair	IMS	3
System, Nuclear Magnetic Resonance Imaging	LNH	3
Armrest, Wheelchair	IML	3
Belt, Wheelchair	IQB	3
Footrest, Wheelchair	IMM	3
Table, Radiographic, Tilting	IXR	3
Media, Reproductive	MQL	3
Active Implantable Bone Conduction Hearing System	PFO	3
Compressor, Cardiac, External	DRM	3
Orthopedic Manual Surgical Instrument	LXH	2
Filler, Bone Void, Calcium Compound	MQV	2
Screw, Fixation, Intraosseous	DZL	2
Orthopedic Stereotaxic Instrument	OLO	2
Drill, Bone, Powered	DZI	2
Brace, Drill	HXY	2
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	2
Agent, Clearing	KEM	2
General Purpose Reagent	PPM	2
Reagents, Specific, Analyte	MVU	2
Retainer, Matrix	JEP	2
Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs	PHO	2
Powered Laser Surgical Instrument	GEX	2
Forceps, General & Plastic Surgery	GEN	2
Needle, Aspiration And Injection, Disposable	GAA	2
Cannula, Surgical, General & Plastic Surgery	GEA	2
Tubes, Gastrointestinal (And Accessories)	KNT	2
Bur, Dental	EJL	2
Tube Tracheostomy And Tube Cuff	JOH	2
Adaptor, Hygiene	ILS	2
Mouthpiece, Saliva Ejector	DYN	2
Accessories, Retractor, Dental	EIF	2
Paper, Articulation	EFH	2
Container, Specimen, Non-Sterile	NNI	2
Tray, Surgical, Instrument	FSM	2
Bandage, Elastic	FQM	2
Dressing, Wound, Occlusive	NAD	2
Frame, Rubber Dam	EJE	2
Automated Radiological Image Processing Software	QIH	2
Guide, Surgical, Instrument	FZX	2
Bag, Reservoir	BTC	2
Set, Tubing And Support, Ventilator (W Harness)	BZO	2
Drain, Tee (Water Trap)	BYH	2
Circuit, Breathing (W Connector, Adaptor, Y Piece)	CAI	2
Tubing, Noninvasive	GAZ	2
Forceps, Ent	KAE	2
Applicator, Ent	KCJ	2
Table, Operating-Room, Electrical	GDC	2
Compressor, Air, Portable	BTI	2
Electrode, Electrocardiograph	DRX	2
Components, Wheelchair	KNN	2
Drill, Dental, Intraoral	DZA	2
Oximeter	DQA	2
System, Thermal Regulating	DWJ	2
Negative Pressure Wound Therapy Powered Suction Pump	OMP	2
Handpiece, Direct Drive, Ac-Powered	EKX	2
Orthosis, Limb Brace	IQI	2
Dental Abutment Design Software For Dental Laboratory	PNP	2
Attachment, Precision, All	EGG	2

Makers in Sweden

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

Maker	Location	Device types	510(k) clearances	PMA approvals	Recall events	Source
Elekta Solutions AB	Stockholm, Sweden	23	93	0	2	api.fda.gov
Nobel Biocare AB	GOTEBORG Vastra Gotaland, Sweden	15	84	0	2	api.fda.gov
Phadia AB	Uppsala, Sweden	30	51	0	6	api.fda.gov
Dentsply IH AB	MOLNDAL Vastra Gotaland, Sweden	11	49	0	0	api.fda.gov
Molnlycke Health Care AB	Molndal Vastra Gotaland, Sweden	20	29	0	0	api.fda.gov
Vitrolife Sweden AB	Vastra Frolunda Vastra Gotaland, Sweden	10	26	0	0	api.fda.gov
Phadia AB	Uppsala, Sweden	19	24	0	0	api.fda.gov
Cochlear Bone Anchored Solutions AB	Molnlycke Vastra Gotaland, Sweden	8	22	0	0	api.fda.gov
Maquet Critical Care AB	SOLNA Stockholm, Sweden	22	22	0	3	api.fda.gov
Neoss AB	Goteborg Vastra Gotaland, Sweden	13	19	0	0	api.fda.gov
Oticon Medical AB	Askim Vastra Gotaland, Sweden	6	16	0	0	api.fda.gov
RaySearch Laboratories AB (publ)	Stockholm, Sweden	1	12	0	59	api.fda.gov
Atos Medical AB	HORBY Skane, Sweden	17	10	0	1	api.fda.gov
Nidacon International AB	MOLNDAL Vastra Gotaland, Sweden	3	10	0	0	api.fda.gov
Permobil AB	Sundsvall Vasternorrland, Sweden	21	9	0	0	api.fda.gov
Wellspect Healthcare	Molndal Vastra Gotaland, Sweden	12	9	0	1	api.fda.gov
Breas Medical AB	MOLNLYCKE Vastra Gotaland, Sweden	12	8	0	1	api.fda.gov
Hemocue AB	ANGELHOLM Skane, Sweden	4	8	0	5	api.fda.gov
Hermes Medical Solutions, AB	Stockholm, Sweden	5	8	0	1	api.fda.gov
Syntheticmr AB	Linkoping Ostergotland, Sweden	2	8	0	0	api.fda.gov
Perimed AB	JARFALLA Stockholm, Sweden	6	7	0	0	api.fda.gov
Cellavision AB	LUND Skane, Sweden	4	6	0	2	api.fda.gov
Clinical Laserthermia Systems AB	Lund Skane, Sweden	5	6	0	1	api.fda.gov
Directa AB	UPPLANDS VAESBY Stockholm, Sweden	32	6	0	0	api.fda.gov
Naturalcycles Nordic AB	Stockholm, Sweden	6	6	0	0	api.fda.gov
Niox AB	Uppsala, Sweden	1	6	0	0	api.fda.gov
Abigo Medical AB	MOLNDAL Vastra Gotaland, Sweden	1	5	0	0	api.fda.gov
Abigo Medical AB	ASKERSUND Orebro, Sweden	1	4	0	0	api.fda.gov
C-Rad Positioning AB	Uppsala, Sweden	2	4	0	3	api.fda.gov
Naslund Medical AB	Huddinge Stockholm, Sweden	1	4	0	0	api.fda.gov
Osstell AB	GOTEBORG Vastra Gotaland, Sweden	2	4	0	0	api.fda.gov
Pharma Systems AB	Lysekil Halland, Sweden	2	4	0	0	api.fda.gov
Qbtech AB	Stockholm, Sweden	1	4	0	0	api.fda.gov
Redsense Medical AB	Halmstad Halland, Sweden	1	4	0	0	api.fda.gov
Senzime AB	Uppsala, Sweden	3	4	0	0	api.fda.gov
AprioMed AB	Uppsala, Sweden	5	3	0	0	api.fda.gov
Biora AB	MALMO Skane, Sweden	3	2	1	0	api.fda.gov
Bone Support AB	LUND Skane, Sweden	3	3	0	0	api.fda.gov
Jolife AB	LUND Skane, Sweden	1	3	0	3	api.fda.gov
Medviso AB	Lund Skane, Sweden	1	3	0	0	api.fda.gov
Neko Health AB	Solna, Sweden	6	3	0	0	api.fda.gov
Q-Med AB	Uppsala, Sweden	5	0	3	0	api.fda.gov
Sectra AB	LINKOPING Ostergotland, Sweden	3	3	0	0	api.fda.gov
Solutions For Tomorrow AB	Vackelsang Kronoberg, Sweden	2	3	0	0	api.fda.gov
Toul Meditech AB	Vasteras Vastmanland, Sweden	1	3	0	0	api.fda.gov
Braincool AB	Lund Skane, Sweden	2	2	0	0	api.fda.gov
Circius Pharma AB	Askim Vastra Gotaland, Sweden	2	2	0	0	api.fda.gov
Coroventis Research AB	Uppsala, Sweden	2	2	0	0	api.fda.gov
Dentatus AB	SPANGA Stockholm, Sweden	16	2	0	0	api.fda.gov
Dignitana AB	Lund Skane, Sweden	1	2	0	0	api.fda.gov
Exini Diagnostics AB	LUND Skane, Sweden	1	2	0	0	api.fda.gov
Gestenco International AB	GOTEBORG Vastra Gotaland, Sweden	6	2	0	0	api.fda.gov
M Dialysis AB	Stockholm, Sweden	3	2	0	0	api.fda.gov
Miris AB	Uppsala, Sweden	2	2	0	0	api.fda.gov
Nobel Biocare AB, Produktion	KARLSKOGA Orebro, Sweden	7	2	0	0	api.fda.gov
Nuvoair AB	Stockholm, Sweden	1	2	0	0	api.fda.gov
Ossdsign	Uppsala, Sweden	1	2	0	0	api.fda.gov
Perstorp Specialty Chemicals AB, Perstorp Pharma	PERSTORP Skane lan [SE-12], Sweden	2	2	0	0	api.fda.gov
Suturion AB	LUND Skane, Sweden	1	2	0	0	api.fda.gov
Xvivo Perfusion AB	Molndal Vastra Gotaland, Sweden	3	1	1	1	api.fda.gov
AB Mando	HUDDINGE Stockholm, Sweden	1	1	0	0	api.fda.gov
Airsonett AB	Angelholm Skane, Sweden	1	1	0	0	api.fda.gov
Algodx AB	Stockholm, Sweden	1	1	0	0	api.fda.gov
Amo Uppsala AB	Uppsala, Sweden	1	0	1	0	api.fda.gov
Amra Medical AB	Linkoping Ostergotland, Sweden	1	1	0	0	api.fda.gov
Arcoma AB	VAXJO Kronoberg, Sweden	6	1	0	1	api.fda.gov
Ascom Sweden AB	Goteborg Vastra Gotaland, Sweden	2	1	0	0	api.fda.gov
Bibb Instruments AB	Lund Skane, Sweden	1	1	0	0	api.fda.gov
Biovica International AB	Uppsala, Sweden	1	1	0	0	api.fda.gov
Boule Medical AB	Spanga Stockholm, Sweden	5	1	0	0	api.fda.gov
Cardia Innovation AB	Bromma Stockholm, Sweden	1	1	0	0	api.fda.gov
CryoIQ global AB	Onsala Halland, Sweden	1	1	0	0	api.fda.gov
Episurf Operations AB	Stockholm, Sweden	2	1	0	0	api.fda.gov
Evolan Pharma AB	Danderyd Stockholm, Sweden	1	1	0	0	api.fda.gov
Fogless International AB	Vaggeryd Jonkoping, Sweden	3	1	0	0	api.fda.gov
Flow Neuroscience AB	Malmo Skane, Sweden	1	0	1	0	api.fda.gov
Fujirebio Diagnostics AB	Molndal Vastra Gotaland, Sweden	1	1	0	0	api.fda.gov
Fujirebio Diagnostics, AB	Gothenburg Vastra Gotaland, Sweden	1	1	0	0	api.fda.gov
Integration Diagnostics Sweden AB	Goteborg Vastra Gotaland, Sweden	1	1	0	0	api.fda.gov
Integrum AB	Molndal Vastra Gotaland, Sweden	1	0	1	0	api.fda.gov
Micropos Medical AB	Goteborg Vastra Gotaland, Sweden	1	1	0	0	api.fda.gov
Minitube AB	TRANGSVIKEN Jamtland, Sweden	3	1	0	0	api.fda.gov
Neonavia AB	Vallentuna Stockholm, Sweden	2	1	0	0	api.fda.gov
Neoventa Medical AB	Molndal Vastra Gotaland, Sweden	1	1	0	0	api.fda.gov
Novus Scientific AB	Uppsala, Sweden	3	1	0	1	api.fda.gov
Ortoma AB	Gothenburg Vastra Gotaland, Sweden	1	1	0	1	api.fda.gov
Occlutech International AB	Helsingborg Skane, Sweden	1	0	1	0	api.fda.gov
PROTOTAL Sweden AB	Jonkoping, Sweden	4	1	0	0	api.fda.gov
Peptonic Medical AB	Bromma Stockholm, Sweden	1	1	0	0	api.fda.gov
Q-linea AB	Uppsala, Sweden	2	1	0	0	api.fda.gov
Qualisys AB	Goteborg Vastra Gotaland, Sweden	1	1	0	0	api.fda.gov
Resitu Medical AB	Uppsala, Sweden	1	1	0	0	api.fda.gov
Rossix AB	Molndal Vastra Gotaland, Sweden	1	1	0	0	api.fda.gov
Scibase AB	sundbyberg Stockholm, Sweden	1	0	1	0	api.fda.gov
Seebreath AB	Stockholm, Sweden	1	1	0	0	api.fda.gov
Svar Life Science AB	MALMO Skane, Sweden	2	1	0	5	api.fda.gov
Xaga Surgical AB	Eslov Skane, Sweden	1	1	0	0	api.fda.gov
AB Elektronik-Konstruktion Innovation (Abelko)	Lulea, Sweden	2	0	0	0	api.fda.gov
AB Germa,sweden	KRISTIANSTAD Skane, Sweden	4	0	0	0	api.fda.gov
AB Sorbinco	MOLNLYCKE Vastra Gotaland, Sweden	1	0	0	0	api.fda.gov
AB Ulax	MOTALA Ostergotland, Sweden	2	0	0	1	api.fda.gov
Absorbest AB	Kisa Ostergotland, Sweden	1	0	0	0	api.fda.gov
Amb Industri AB	Broakulla Kalmar, Sweden	3	0	0	0	api.fda.gov
Anatomic Sitt I Norrkoping Aktiebolag	Norrkoping Ostergotland, Sweden	8	0	0	0	api.fda.gov
Apotek Produktion & Laboratorier AB	Umea Vasterbotten, Sweden	2	0	0	0	api.fda.gov
Arjohuntleigh AB	MALMO Skane, Sweden	1	0	0	3	api.fda.gov
Arta Plast AB	Tyresoe Stockholm, Sweden	2	0	0	0	api.fda.gov
Ate Pharmacare AB	Goteborg Vastra Gotaland, Sweden	2	0	0	0	api.fda.gov
Attends Healthcare AB	ANEBY Jonkoping, Sweden	1	0	0	0	api.fda.gov
Aurena Laboratories AB	Karlstad Varmland, Sweden	3	0	0	0	api.fda.gov
Acne Studios AB	Spanga Stockholm, Sweden	1	0	0	0	api.fda.gov
Beneli AB	Helsingborg Skane, Sweden	1	0	0	0	api.fda.gov
Bio-Hospital AB	KOPPARBERG Orebro, Sweden	2	0	0	0	api.fda.gov
Bioservo AB	Kista Stockholm, Sweden	1	0	0	0	api.fda.gov
Bluebird Medical AB	Fjaras Halland, Sweden	1	0	0	0	api.fda.gov
Blomdahl Medical AB	Halmstad Halland, Sweden	1	0	0	0	api.fda.gov
Camp Scandinavia AB	HELSINGBORG Skane, Sweden	7	0	0	0	api.fda.gov
Capitainer AB	Solna Stockholm, Sweden	2	0	0	0	api.fda.gov
Cenova AB	MJOLBY Ostergotland, Sweden	12	0	0	0	api.fda.gov
Cepheid AB	SOLNA Stockholm, Sweden	14	0	0	0	api.fda.gov
Cetro Medical AB	Smalandsstenar Jonkoping, Sweden	2	0	0	0	api.fda.gov
Chimi AB	Stockholm, Sweden	1	0	0	0	api.fda.gov
Cytodelics AB	Sodertalje Stockholm, Sweden	2	0	0	0	api.fda.gov
Conroy Medical AB	UPPLANDS VASBY Stockholm, Sweden	1	0	0	0	api.fda.gov
DYNAVOX Group AB	Stockholm, Sweden	1	0	0	0	api.fda.gov
Direct Healthcare Group Sverige AB	Reftele Jonkoping, Sweden	2	0	0	0	api.fda.gov
Direct Healthcare Group Sverige AB	Kista Stockholm, Sweden	6	0	0	3	api.fda.gov
Elos Medtech Timmersdala AB	TIMMERSDALA Vastra Gotaland, Sweden	9	0	0	0	api.fda.gov
Etac Supply Center AB	Anderstorp Jonkoping, Sweden	18	0	0	4	api.fda.gov
Elos Medtech Skara AB	Skara Vastra Gotaland, Sweden	1	0	0	0	api.fda.gov
Essity Hygiene Health AB	FALKENBERG Halland, Sweden	1	0	0	0	api.fda.gov
Essity Hygiene and Health AB	Gothenburg Vastra Gotaland, Sweden	5	0	0	0	api.fda.gov
Fillauer Europe	JARFALLA Stockholm, Sweden	7	0	0	0	api.fda.gov
Flodins Filter AB	Lysekil Vastra Gotaland, Sweden	1	0	0	0	api.fda.gov
Fresenius Kabi AB	Uppsala, Sweden	2	0	0	0	api.fda.gov
Frohe Sweden AB	Tyreso, Sweden	7	0	0	0	api.fda.gov
Getinge Disinfection AB	VAXJO Kronoberg, Sweden	2	0	0	6	api.fda.gov
Genome Diagnostics Sweden AB	Stockholm, Sweden	1	0	0	0	api.fda.gov
Hammarplast Medical AB	Lidkoping Vastra Gotaland, Sweden	4	0	0	0	api.fda.gov
Harnosands Plastindustri AB	Harnosand Vasternorrland, Sweden	1	0	0	0	api.fda.gov
Human Care HC AB	Stockholm, Sweden	5	0	0	1	api.fda.gov
Interlinked AB	Stockholm, Sweden	1	0	0	0	api.fda.gov
Inission Syd AB (Malmo AB)	Malmo Skane, Sweden	3	0	0	0	api.fda.gov
J.h.orsing AB	Helsingborg Skane, Sweden	2	0	0	0	api.fda.gov
Kitron AB	Jonkoping, Sweden	3	0	0	0	api.fda.gov
Konsultbyran Process Construction AB	Tommarp Skane, Sweden	1	0	0	0	api.fda.gov
Laser Nova AB	Ostersund Jamtland, Sweden	1	0	0	0	api.fda.gov
Liko AB	LULEA Norrbotten, Sweden	2	0	0	0	api.fda.gov
Lindhextend AB	Halmstad Halland, Sweden	1	0	0	0	api.fda.gov
Linxens Sweden AB	Angelholm Skane, Sweden	6	0	0	0	api.fda.gov
Mediplast AB	MALMO Skane, Sweden	4	0	0	0	api.fda.gov
Meloq AB	Stockholm, Sweden	3	0	0	0	api.fda.gov
Mercado Medic AB	Lidingo Stockholm, Sweden	1	0	0	0	api.fda.gov
Mercodia AB	Uppsala, Sweden	6	0	0	0	api.fda.gov
Mikrolab Stockholm AB	Sollentuna Stockholm, Sweden	1	0	0	0	api.fda.gov
Montex AB	Jamjoe Blekinge, Sweden	1	0	0	0	api.fda.gov
National Bredaryd Performance Polymers AB	Bredaryd Vastra Gotaland, Sweden	1	0	0	0	api.fda.gov
Nolato Meditech	Horby Skane, Sweden	2	0	0	0	api.fda.gov
Nolato Meditor AB	TOREKOV Skane, Sweden	3	0	0	0	api.fda.gov
Nord Ability AB	Smogen Vastra Gotaland, Sweden	1	0	0	0	api.fda.gov
NOTE Herrljunga AB	Herrljunga Vastra Gotaland, Sweden	1	0	0	0	api.fda.gov
Note Torsby AB	Torsby Varmland, Sweden	1	0	0	0	api.fda.gov
Onetwo Analytics AB	Stockholm, Sweden	1	0	0	0	api.fda.gov
Opaje AB	Stockholm, Sweden	2	0	0	0	api.fda.gov
Paindrainer AB	Lund Skane, Sweden	2	0	0	0	api.fda.gov
Part Precision Sweden AB	Mariestad Vastra Gotaland, Sweden	4	0	0	0	api.fda.gov
Reison Medical AB	HALLSTAHAMMAR Vastmanland, Sweden	2	0	0	0	api.fda.gov
Remeda AB	Halmstad Halland, Sweden	2	0	0	0	api.fda.gov
Rini Ergoteknik AB	Vallentuna Uppsala, Sweden	3	0	0	0	api.fda.gov
Samhall AB	Svenstavik Jamtland, Sweden	2	0	0	0	api.fda.gov
Sanmina-Sci AB	SJALEVAD Vasternorrland, Sweden	3	0	0	0	api.fda.gov
Scanfil Atvidaberg AB	Atvidaberg Ostergotland, Sweden	2	0	0	0	api.fda.gov
Selahatin AB	Stockholm, Sweden	1	0	0	0	api.fda.gov
Sonesta Medical AB	Stockholm, Sweden	2	0	0	2	api.fda.gov
Specialplast Wensbo AB	Gislaved Jonkoping, Sweden	2	0	0	0	api.fda.gov
Stille AB	Torshalla Sodermanland, Sweden	39	0	0	2	api.fda.gov
Stoeryd AB	Tranas Jonkoping, Sweden	1	0	0	0	api.fda.gov
STOKVIS Nordic	Norrkoping Ostergotland, Sweden	2	0	0	0	api.fda.gov
Svenska Dentorama AB	SOLLENTUNA Stockholm, Sweden	13	0	0	0	api.fda.gov
Tepe Munhygienprodukter AB	MALMO Skane, Sweden	4	0	0	0	api.fda.gov
Texray AB	Goteborg Vastra Gotaland, Sweden	2	0	0	0	api.fda.gov
TR Equipment AB	TRANAS Jonkoping, Sweden	3	0	0	0	api.fda.gov
Trionic Sverige AB	Uppsala, Sweden	1	0	0	0	api.fda.gov
Turon Medtech AB	Varberg Halland, Sweden	2	0	0	0	api.fda.gov
Wasserman Medic AB	Hollviken Skane, Sweden	1	0	0	0	api.fda.gov
Willo AB	Vaxjo Kronoberg, Sweden	2	0	0	0	api.fda.gov
X-Med AB	Vasteras Vastmanland, Sweden	1	0	0	0	api.fda.gov
Yourrad AB	Kungsbacka Halland, Sweden	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.