EU → North America Device Access

Medical device manufacturers in Sweden and the U.S. market

163 manufacturers registered in Sweden with at least 5 devices declared in the European database. Of these, 89 were not found in the U.S. FDA establishment register, 72 were matched, and 2 have a similar name that needs checking.

Against the Canadian register, 126 of them were not found, 37 hold a Health Canada licence, and 0 need checking.

ManufacturerDevices FDAHealth Canada
ArjoHuntleigh AB8 654Registered with FDALicensed in Canada
Nobel Biocare AB3 516Registered with FDALicensed in Canada
Mediroyal Nordic AB2 066Not found in the FDA registerNot found in the Canadian register
Multilens AB2 015Not found in the FDA registerNot found in the Canadian register
Camp Scandinavia AB1 922Registered with FDANot found in the Canadian register
Essity Hygiene and Health AB1 808Registered with FDALicensed in Canada
Nimacare AB1 677Not found in the FDA registerNot found in the Canadian register
B.I.M.A. PLASTTEKNIK AB1 667Not found in the FDA registerNot found in the Canadian register
Etac Supply Center AB1 209Registered with FDANot found in the Canadian register
Mercado Medic AB1 125Registered with FDANot found in the Canadian register
Haco Tellus AB868Not found in the FDA registerNot found in the Canadian register
Phadia AB802Registered with FDALicensed in Canada
Catell AB689Not found in the FDA registerNot found in the Canadian register
Sjöbloms Sjukvårdsutrustning AB540Not found in the FDA registerNot found in the Canadian register
AB Germa427Not found in the FDA registerNot found in the Canadian register
Wellspect HealthCare395Registered with FDALicensed in Canada
Swereco AB378Not found in the FDA registerNot found in the Canadian register
SIC invent Sweden AB346Not found in the FDA registerNot found in the Canadian register
Invacare Rea AB335Similar name found — unverifiedNot found in the Canadian register
Attends Healthcare AB311Registered with FDANot found in the Canadian register
Mediplast AB273Registered with FDANot found in the Canadian register
Liko Aktiebolag269Not found in the FDA registerNot found in the Canadian register
Getinge Disinfection AB251Registered with FDALicensed in Canada
Vitrolife Sweden AB227Registered with FDALicensed in Canada
Neoss AB209Registered with FDALicensed in Canada
Pharma Systems AB190Registered with FDALicensed in Canada
CareDx AB183Registered with FDALicensed in Canada
Atos Medical AB181Registered with FDALicensed in Canada
Episurf Operations AB164Registered with FDANot found in the Canadian register
C LindheXtend AB162Not found in the FDA registerNot found in the Canadian register
Stille AB149Registered with FDANot found in the Canadian register
Osstell AB142Registered with FDALicensed in Canada
Orkla Wound Care AB138Not found in the FDA registerLicensed in Canada
HD Rehab AB134Not found in the FDA registerNot found in the Canadian register
Oticon Medical AB133Registered with FDALicensed in Canada
Aurena Laboratories AB124Registered with FDALicensed in Canada
Human Care HC AB121Registered with FDANot found in the Canadian register
Disentis AB109Not found in the FDA registerNot found in the Canadian register
RFSU AB101Not found in the FDA registerNot found in the Canadian register
Cetro Medical AB96Registered with FDANot found in the Canadian register
Inverdia AB95Not found in the FDA registerNot found in the Canadian register
Bactiguard AB91Not found in the FDA registerLicensed in Canada
Breas Medical AB91Registered with FDALicensed in Canada
Nordic activity AB81Not found in the FDA registerNot found in the Canadian register
Erimed International AB80Not found in the FDA registerNot found in the Canadian register
Pjama AB78Not found in the FDA registerNot found in the Canadian register
Abena AB77Not found in the FDA registerNot found in the Canadian register
Kanmed AB72Not found in the FDA registerLicensed in Canada
Cellcomb71Not found in the FDA registerNot found in the Canadian register
Maquet Critical Care AB71Registered with FDALicensed in Canada
TR Equipment AB70Registered with FDANot found in the Canadian register
Customized innovations i Sverige AB68Not found in the FDA registerNot found in the Canadian register
Unident AB67Not found in the FDA registerNot found in the Canadian register
Nord Ability AB64Registered with FDANot found in the Canadian register
Optergo AB62Not found in the FDA registerNot found in the Canadian register
Adaptis Spektra AB61Not found in the FDA registerNot found in the Canadian register
Novista of Sweden AB61Not found in the FDA registerNot found in the Canadian register
Nordic Biomarker AB54Not found in the FDA registerNot found in the Canadian register
Devyser AB50Not found in the FDA registerLicensed in Canada
AprioMed AB48Registered with FDALicensed in Canada
CellaVision AB48Registered with FDALicensed in Canada
Mölnlycke Health Care AB48Not found in the FDA registerNot found in the Canadian register
Naslund Medical AB48Registered with FDANot found in the Canadian register
Trust Care AB48Not found in the FDA registerNot found in the Canadian register
AJ Medical KB46Not found in the FDA registerNot found in the Canadian register
AMO Uppsala AB46Registered with FDANot found in the Canadian register
CryoIQ global AB46Registered with FDANot found in the Canadian register
Tjugohundra18 AB46Not found in the FDA registerNot found in the Canadian register
Sunmedic AB44Similar name found — unverifiedNot found in the Canadian register
Harry Holms AB43Not found in the FDA registerNot found in the Canadian register
Integrum AB42Registered with FDANot found in the Canadian register
SIT Swedish Implant Technology AB41Not found in the FDA registerNot found in the Canadian register
AristoDent AB40Not found in the FDA registerNot found in the Canadian register
Careva System AB40Not found in the FDA registerNot found in the Canadian register
LVI Low Vision International AB40Not found in the FDA registerNot found in the Canadian register
Bellman & Symfon Group AB38Not found in the FDA registerNot found in the Canadian register
Svan Care AB38Not found in the FDA registerNot found in the Canadian register
Support Design AB36Not found in the FDA registerNot found in the Canadian register
ComfortSystem Scandinavia AB35Not found in the FDA registerNot found in the Canadian register
Fogless International AB34Registered with FDANot found in the Canadian register
ABIGO Medical AB32Registered with FDALicensed in Canada
Labex Reagens AB31Not found in the FDA registerNot found in the Canadian register
SVENSKA DENTORAMA AB30Registered with FDANot found in the Canadian register
Minitube AB29Registered with FDANot found in the Canadian register
C-RAD Positioning AB28Registered with FDALicensed in Canada
Medical Innovation Design MID AB28Not found in the FDA registerNot found in the Canadian register
Caretec i Forserum AB26Not found in the FDA registerNot found in the Canadian register
Wiges AB26Not found in the FDA registerNot found in the Canadian register
Nil Medical AB25Not found in the FDA registerNot found in the Canadian register
Ortoma AB25Registered with FDANot found in the Canadian register
Q-Med AB25Registered with FDALicensed in Canada
Circius Pharma AB24Registered with FDANot found in the Canadian register
M Dialysis AB24Registered with FDANot found in the Canadian register
Rolf Kullgren AB24Not found in the FDA registerNot found in the Canadian register
Texray AB24Registered with FDANot found in the Canadian register
Bohus BioTech AB22Not found in the FDA registerNot found in the Canadian register
Cepheid AB22Registered with FDALicensed in Canada
Boule Medical AB21Registered with FDANot found in the Canadian register
Embreis AB20Not found in the FDA registerNot found in the Canadian register
Anatomic Sitt i Norrköping AB19Not found in the FDA registerNot found in the Canadian register
Fujirebio Diagnostics AB19Registered with FDALicensed in Canada
Sterisol AB18Not found in the FDA registerNot found in the Canadian register
Trident Industri AB17Not found in the FDA registerNot found in the Canadian register
Conroy Medical AB16Registered with FDANot found in the Canadian register
Turon MedTech AB16Registered with FDANot found in the Canadian register
AKLA AB15Not found in the FDA registerNot found in the Canadian register
Burman Enterprise15Not found in the FDA registerNot found in the Canadian register
Europea i Malmö AB15Not found in the FDA registerNot found in the Canadian register
Hammarplast Medical AB15Registered with FDANot found in the Canadian register
ImmunoIVD AB15Not found in the FDA registerNot found in the Canadian register
Cybergene AB14Not found in the FDA registerNot found in the Canadian register
Nidacon International AB14Registered with FDALicensed in Canada
RAYSEARCH LABORATORIES AB (PUBL)14Registered with FDALicensed in Canada
Senzime AB14Registered with FDANot found in the Canadian register
Jolife AB13Registered with FDALicensed in Canada
Remeda AB13Registered with FDANot found in the Canadian register
Absorbest AB12Registered with FDANot found in the Canadian register
Aktiebolaget Ulax12Not found in the FDA registerNot found in the Canadian register
BrainCool AB12Registered with FDANot found in the Canadian register
Clemondo AB12Not found in the FDA registerNot found in the Canadian register
NIOX AB12Registered with FDANot found in the Canadian register
Stretch Care AB12Not found in the FDA registerNot found in the Canadian register
Clinical Laserthermia Systems AB11Registered with FDANot found in the Canadian register
Elekta Solutions AB11Registered with FDALicensed in Canada
Enzymatica AB11Not found in the FDA registerNot found in the Canadian register
Lumina Adhesives AB11Not found in the FDA registerNot found in the Canadian register
Mercodia AB11Registered with FDALicensed in Canada
MIM Pharma Europe AB11Not found in the FDA registerNot found in the Canadian register
Modulpac AB11Not found in the FDA registerNot found in the Canadian register
Nimmu Scandinavia AB11Not found in the FDA registerNot found in the Canadian register
Rini Ergoteknik AB10Registered with FDANot found in the Canadian register
Spectro Analytic Irradia AB10Not found in the FDA registerNot found in the Canadian register
Krucom AB9Not found in the FDA registerNot found in the Canadian register
Neko Health AB9Registered with FDANot found in the Canadian register
O&P Solutions AB9Not found in the FDA registerNot found in the Canadian register
TePe Munhygienprodukter AB9Registered with FDANot found in the Canadian register
Westerstrand Urfabrik AB9Not found in the FDA registerNot found in the Canadian register
Funktionsverket AB8Not found in the FDA registerNot found in the Canadian register
Linköpings Tekniska Fabrik AB8Not found in the FDA registerNot found in the Canadian register
MA-GO Scandinavia AB8Not found in the FDA registerNot found in the Canadian register
Toul Meditech AB8Registered with FDANot found in the Canadian register
Trionic Sverige AB8Registered with FDANot found in the Canadian register
Aktiebolaget Elektronik-Konstruktion Innovation7Not found in the FDA registerNot found in the Canadian register
Biocool AB7Not found in the FDA registerNot found in the Canadian register
Hermes Medical Solutions AB7Registered with FDALicensed in Canada
NordiCare Ortopedi & Rehab AB7Not found in the FDA registerNot found in the Canadian register
Redsense Medical AB7Registered with FDALicensed in Canada
Cambio Healthcare Systems AB6Not found in the FDA registerNot found in the Canadian register
Duearity AB6Not found in the FDA registerNot found in the Canadian register
I & B Medical AB6Not found in the FDA registerNot found in the Canadian register
Monivent AB6Not found in the FDA registerNot found in the Canadian register
ORTHO KM6Not found in the FDA registerNot found in the Canadian register
PulseLavage AB6Not found in the FDA registerNot found in the Canadian register
Conscious Breathing Institute Sweden AB5Not found in the FDA registerNot found in the Canadian register
Coroventis Research AB5Registered with FDALicensed in Canada
Medviso AB5Registered with FDANot found in the Canadian register
Neonavia AB5Registered with FDANot found in the Canadian register
nWise AB5Not found in the FDA registerNot found in the Canadian register
ProstaLund AB5Not found in the FDA registerLicensed in Canada
Q-linea AB5Registered with FDANot found in the Canadian register
Swedish Hospital Supply AB5Not found in the FDA registerNot found in the Canadian register
The Active Brands Group Scandinavia AB5Not found in the FDA registerNot found in the Canadian register
XVIVO Perfusion AB5Registered with FDALicensed in Canada

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