EU → North America Device Access

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

194 manufacturers registered in Switzerland with at least 5 devices declared in the European database. Of these, 93 were not found in the U.S. FDA establishment register, 94 were matched, and 7 have a similar name that needs checking.

Against the Canadian register, 132 of them were not found, 58 hold a Health Canada licence, and 4 need checking.

ManufacturerDevices FDAHealth Canada
Synthes GmbH31 944Registered with FDALicensed in Canada
SIGVARIS AG21 743Registered with FDANot found in the Canadian register
Medacta International SA8 486Registered with FDALicensed in Canada
Stryker GmbH7 152Registered with FDALicensed in Canada
Medos International SARL7 113Registered with FDALicensed in Canada
Medartis AG6 915Registered with FDALicensed in Canada
STAAR Surgical AG4 854Registered with FDALicensed in Canada
Assut Medical Sàrl4 341Not found in the FDA registerNot found in the Canadian register
Sonova AG3 796Registered with FDALicensed in Canada
GLOOR AG2 761Registered with FDANot found in the Canadian register
Jota AG2 690Registered with FDALicensed in Canada
Institut Straumann AG2 449Registered with FDALicensed in Canada
Dent4You AG1 943Registered with FDALicensed in Canada
Diaswiss SA1 797Similar name found — unverifiedNot found in the Canadian register
Novodent SA1 537Not found in the FDA registerNot found in the Canadian register
Candulor AG1 434Registered with FDALicensed in Canada
TRATE AG1 172Registered with FDANot found in the Canadian register
FKG Dentaire Sàrl1 168Similar name found — unverifiedSimilar name found — unverified
IML SA982Not found in the FDA registerNot found in the Canadian register
X.NOV MEDICAL TECHNOLOGY832Not found in the FDA registerNot found in the Canadian register
OBA AG637Not found in the FDA registerNot found in the Canadian register
MPS Micro Precision Systems AG486Registered with FDANot found in the Canadian register
icotec ag481Registered with FDALicensed in Canada
Künzli SwissSchuh AG464Not found in the FDA registerNot found in the Canadian register
Rontis Corporation SA443Not found in the FDA registerNot found in the Canadian register
Polydentia SA402Similar name found — unverifiedNot found in the Canadian register
Accuratus AG379Registered with FDANot found in the Canadian register
Biotronik AG370Registered with FDALicensed in Canada
Tobler & Co. AG342Not found in the FDA registerNot found in the Canadian register
Medicel AG318Registered with FDANot found in the Canadian register
Akzenta International SA309Not found in the FDA registerNot found in the Canadian register
Bonebridge AG308Registered with FDANot found in the Canadian register
Thommen Medical AG292Registered with FDALicensed in Canada
Maillefer Instruments Holding Sàrl288Similar name found — unverifiedSimilar name found — unverified
SURGICON AG268Registered with FDALicensed in Canada
Vantive Health GmbH252Registered with FDALicensed in Canada
Atesos medical AG244Not found in the FDA registerNot found in the Canadian register
Incipio Devices SA240Registered with FDANot found in the Canadian register
Medela AG226Registered with FDALicensed in Canada
Produits Dentaires SA225Registered with FDANot found in the Canadian register
Biosensors Europe SA223Not found in the FDA registerNot found in the Canadian register
Keri Medical SA220Registered with FDANot found in the Canadian register
Bucher Leichtbau AG190Not found in the FDA registerNot found in the Canadian register
SPD Swiss Precision Diagnostics GmbH190Registered with FDALicensed in Canada
CeramTec Schweiz GmbH189Registered with FDANot found in the Canadian register
Baxter Healthcare SA186Similar name found — unverifiedLicensed in Canada
Derungs Licht AG156Registered with FDANot found in the Canadian register
medmix Switzerland AG145Registered with FDANot found in the Canadian register
Oertli Instrumente AG145Registered with FDALicensed in Canada
Bien-Air Dental SA142Registered with FDALicensed in Canada
Haag-Streit AG139Registered with FDALicensed in Canada
Applimed SA138Not found in the FDA registerNot found in the Canadian register
SIC invent AG127Registered with FDANot found in the Canadian register
Z-Systems AG127Registered with FDALicensed in Canada
Hamilton AG121Registered with FDANot found in the Canadian register
mdd Company GmbH120Not found in the FDA registerNot found in the Canadian register
LiNA Medical AG116Registered with FDALicensed in Canada
X-os S.A.115Not found in the FDA registerNot found in the Canadian register
Ardo medical AG108Registered with FDALicensed in Canada
Schaerer Medical AG98Registered with FDANot found in the Canadian register
TiMask Suisse Sagl98Not found in the FDA registerNot found in the Canadian register
LifeScan Europe GmbH88Registered with FDALicensed in Canada
InfinetaMed AG87Registered with FDALicensed in Canada
Swissdentacare SA86Not found in the FDA registerNot found in the Canadian register
B. Braun Medical AG84Registered with FDALicensed in Canada
SCHILLER AG80Registered with FDALicensed in Canada
Bürki inno med AG78Not found in the FDA registerNot found in the Canadian register
Zimmer Switzerland Manufacturing GmbH78Not found in the FDA registerLicensed in Canada
ForaCare Suisse AG77Not found in the FDA registerNot found in the Canadian register
Airex AG75Not found in the FDA registerNot found in the Canadian register
Imetric 4D Imaging Sarl75Not found in the FDA registerNot found in the Canadian register
Oscimed SA75Registered with FDANot found in the Canadian register
Biodenta Swiss AG74Registered with FDALicensed in Canada
SANKOM SA74Not found in the FDA registerNot found in the Canadian register
NOUVAG AG73Registered with FDALicensed in Canada
Baitella AG72Registered with FDANot found in the Canadian register
Rossmax Swiss GmbH68Not found in the FDA registerNot found in the Canadian register
SIS Medical AG68Registered with FDALicensed in Canada
SIE AG, Surgical Instrument Engineering62Not found in the FDA registerLicensed in Canada
KAZ Europe Sàrl61Not found in the FDA registerNot found in the Canadian register
STORZ MEDICAL AG61Registered with FDALicensed in Canada
Pall International SARL60Registered with FDANot found in the Canadian register
Spineart SA59Registered with FDANot found in the Canadian register
SDS Swiss Dental Solutions AG56Registered with FDANot found in the Canadian register
INFOMED SA55Registered with FDANot found in the Canadian register
Polichem SA, Lussemburgo, succursale di Mendrisi55Not found in the FDA registerNot found in the Canadian register
B.Well Swiss AG54Not found in the FDA registerNot found in the Canadian register
Leica Microsystems (Schweiz) AG52Registered with FDALicensed in Canada
Bien-Air Surgery SA51Registered with FDALicensed in Canada
Regen Lab SA51Registered with FDALicensed in Canada
Ares Trading SA50Registered with FDALicensed in Canada
Orphée SA46Not found in the FDA registerNot found in the Canadian register
Sentec AG46Registered with FDALicensed in Canada
IVF HARTMANN AG45Registered with FDANot found in the Canadian register
mylife Diabetes Care AG45Not found in the FDA registerNot found in the Canadian register
PRIMA Lab SA45Not found in the FDA registerNot found in the Canadian register
BIOSYNEX Swiss SA41Not found in the FDA registerNot found in the Canadian register
DEVINTEC SAGL41Not found in the FDA registerNot found in the Canadian register
Scanatron AG41Not found in the FDA registerNot found in the Canadian register
Bayer Consumer Care AG37Not found in the FDA registerNot found in the Canadian register
Hocoma AG37Not found in the FDA registerLicensed in Canada
Intensiv SA35Registered with FDALicensed in Canada
NDD Medizintechnik AG35Registered with FDALicensed in Canada
QuantièmePlus SA35Not found in the FDA registerNot found in the Canadian register
SOFAR SWISS SA34Not found in the FDA registerNot found in the Canadian register
Bordier Affinity Products SA32Registered with FDANot found in the Canadian register
Haemonetics S.A.32Not found in the FDA registerLicensed in Canada
SpineSave AG31Not found in the FDA registerNot found in the Canadian register
Enbio Group AG29Registered with FDALicensed in Canada
Optima Medical Swiss AG29Not found in the FDA registerLicensed in Canada
Technimed AG29Not found in the FDA registerNot found in the Canadian register
Ascensia Diabetes Care Holdings AG28Registered with FDALicensed in Canada
Oncobit AG28Not found in the FDA registerNot found in the Canadian register
AliveDx Suisse SA27Not found in the FDA registerLicensed in Canada
Novocure GmbH27Registered with FDALicensed in Canada
Harald Nordin S.A.26Registered with FDANot found in the Canadian register
Medion Grifols Diagnostics AG26Registered with FDALicensed in Canada
Degradable Solutions AG24Not found in the FDA registerNot found in the Canadian register
read on GmbH24Not found in the FDA registerNot found in the Canadian register
Innovative Orthopedic Technologies IOT AG23Registered with FDANot found in the Canadian register
MTS Maschinenbau AG22Not found in the FDA registerNot found in the Canadian register
Biover AG21Registered with FDANot found in the Canadian register
Effectum Medical AG21Not found in the FDA registerNot found in the Canadian register
Samarit Medical AG21Registered with FDANot found in the Canadian register
APIS Technologies20Registered with FDANot found in the Canadian register
Haleon CH SARL20Not found in the FDA registerNot found in the Canadian register
Tillotts Pharma AG20Not found in the FDA registerNot found in the Canadian register
BPR Swiss GmbH19Not found in the FDA registerNot found in the Canadian register
Bracco Injeneering SA19Similar name found — unverifiedSimilar name found — unverified
E.M.S. Electro Medical Systems S.A.19Registered with FDALicensed in Canada
PB Swiss Tools AG19Registered with FDANot found in the Canadian register
Sunstar Europe SA19Not found in the FDA registerNot found in the Canadian register
GetSet Surgical SA18Similar name found — unverifiedNot found in the Canadian register
Pearl Technology AG18Registered with FDANot found in the Canadian register
41medical AG17Not found in the FDA registerNot found in the Canadian register
CASCINATION AG17Registered with FDANot found in the Canadian register
Smartcanula LLC17Not found in the FDA registerNot found in the Canadian register
SOPHiA GENETICS SA17Not found in the FDA registerNot found in the Canadian register
Arcomed AG16Not found in the FDA registerNot found in the Canadian register
S&T AG16Registered with FDANot found in the Canadian register
Juvaplus SA14Not found in the FDA registerLicensed in Canada
macu4 AG14Registered with FDANot found in the Canadian register
Polaroid Therapeutics AG14Not found in the FDA registerNot found in the Canadian register
Zephyr Surgical Implants sàrl14Not found in the FDA registerSimilar name found — unverified
Aleva Neurotherapeutics SA13Not found in the FDA registerNot found in the Canadian register
Lallemand Pharma13Not found in the FDA registerNot found in the Canadian register
Distalmotion SA12Registered with FDANot found in the Canadian register
MAM Baby AG12Registered with FDANot found in the Canadian register
Zetta25 AG12Registered with FDALicensed in Canada
Duracell International Operations SARL11Not found in the FDA registerNot found in the Canadian register
Intigena (Schweiz) AG11Not found in the FDA registerNot found in the Canadian register
ME Medical AG11Not found in the FDA registerNot found in the Canadian register
Pentapharm AG11Registered with FDALicensed in Canada
Phonak AG11Not found in the FDA registerNot found in the Canadian register
4bases SA10Not found in the FDA registerNot found in the Canadian register
Professional Derma SA10Not found in the FDA registerNot found in the Canadian register
Spectrum Dynamics Medical SA10Registered with FDALicensed in Canada
Anton Meyer & Co. AG9Registered with FDANot found in the Canadian register
Luciole Medical AG9Not found in the FDA registerNot found in the Canadian register
Medcem GmbH9Not found in the FDA registerNot found in the Canadian register
Bones AG8Not found in the FDA registerNot found in the Canadian register
LEVO AG8Registered with FDANot found in the Canadian register
Messer Schweiz AG8Not found in the FDA registerNot found in the Canadian register
Swiss Footcare Laboratories sarl8Not found in the FDA registerNot found in the Canadian register
AXIS DENTAL SARL7Not found in the FDA registerNot found in the Canadian register
Emovo Care7Not found in the FDA registerNot found in the Canadian register
I-Dent Innovations for Dentistry SA7Registered with FDANot found in the Canadian register
Ikerian AG7Not found in the FDA registerNot found in the Canadian register
Inpeco SA7Registered with FDANot found in the Canadian register
Max Stäubli AG7Not found in the FDA registerNot found in the Canadian register
MDT Int'l SA7Not found in the FDA registerLicensed in Canada
Pregnolia AG7Not found in the FDA registerNot found in the Canadian register
99 Technologies SA6Not found in the FDA registerNot found in the Canadian register
Anel AG6Not found in the FDA registerNot found in the Canadian register
BRACCO SUISSE SA6Not found in the FDA registerNot found in the Canadian register
Brütsch Technology AG6Not found in the FDA registerNot found in the Canadian register
GaDia SA6Not found in the FDA registerNot found in the Canadian register
Lang-Stereotest AG6Registered with FDANot found in the Canadian register
Nocubi AG6Not found in the FDA registerNot found in the Canadian register
Piomic Medical AG6Not found in the FDA registerNot found in the Canadian register
Sensopro AG6Not found in the FDA registerNot found in the Canadian register
Sleepiz AG6Registered with FDANot found in the Canadian register
AD SWISS MEDTECH SA5Not found in the FDA registerNot found in the Canadian register
Aktiia SA5Registered with FDALicensed in Canada
Bariatric Solutions GmbH5Not found in the FDA registerNot found in the Canadian register
Helmedica AG5Not found in the FDA registerNot found in the Canadian register
Medimaps Group SA5Registered with FDANot found in the Canadian register
Miromed Group SA5Not found in the FDA registerNot found in the Canadian register
Nalkein SA5Not found in the FDA registerNot found in the Canadian register
NeuroXtherapeutics SA5Registered with FDANot found in the Canadian register
PreAnalytiX GmbH5Registered with FDANot found in the Canadian register
SMT Swiss Microtechnology AG5Not found in the FDA registerLicensed in Canada
Tecan Schweiz AG5Registered with FDANot found in the Canadian register
Top Engineering Sarl5Not found in the FDA registerNot found in the Canadian register

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