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Data / FDA device clearances / Switzerland

FDA device clearances in Switzerland: 126 since Nov 2024

The full list. FDA device clearances for applicants in Switzerland: 126 rows for $6.30, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 4 rows a month. The new rows come each week by email, $19 a month.

Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (pathway, device name, applicant address, contact, date received, device type and 5 more), which open on your screen as soon as the payment clears and come by email. The weekly rows run until you cancel, from the link in each delivery. The rows on this page are a sample.

For agents and scripts: this list is ordered at https://specstream.ai/data/fda-clearances/country/switzerland, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated October 30, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).

FDA made 126 device decisions for applicants in Switzerland from November 13, 2024 to October 30, 2026: 126 510(k) clearances and De Novo grants and 0 PMA approvals and supplements, for 50 applicants. The newest, K260360 on October 30, 2026, is AesyBite Active from Aesyra SA.

The request: Every new FDA device clearance or approval for a company in Switzerland, with its address, the device and the product code. $10 of credit on sign-up, no card.

SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

  • 126Decisions
  • 126510(k) and De Novo
  • 0PMA
  • October 30, 2026Latest decision

Newest decisions

The newest 100 of 126, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

Decision dateNumberDeviceApplicantLocationDecisionTypeProduct codeSource
October 30, 2026K260360AesyBite ActiveAesyra SASwitzerlandSubstantially Equivalent510(k) traditionalHCCaccessdata.fda.gov
October 29, 2026K263582KeriFlex® MCP and PIP Finger Joint ProsthesesKeri Medical SASwitzerlandSubstantially Equivalent510(k) specialKYJaccessdata.fda.gov
October 23, 2026K262080OTOPLANCascination AGSwitzerlandSubstantially Equivalent510(k) traditionalQQEaccessdata.fda.gov
October 8, 2026K263680One Coat Bond; One Coat Bond SLDent4You AGSwitzerlandSubstantially Equivalent510(k) traditionalKLEaccessdata.fda.gov
September 29, 2026K261225CAS-One IRCascination AGSwitzerlandSubstantially Equivalent510(k) traditionalJAKaccessdata.fda.gov
September 22, 2026K253762ErgoSteel (ES0001/696)Strongback Mobility AG C/O Blueaudit GmbHSwitzerlandSubstantially Equivalent510(k) traditionalIORaccessdata.fda.gov
September 17, 2026K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.SwitzerlandSubstantially Equivalent510(k) traditionalLZOaccessdata.fda.gov
September 15, 2026K262057GMK ExtensionMedacta International SASwitzerlandSubstantially Equivalent510(k) traditionalJWHaccessdata.fda.gov
September 11, 2026K260115DRIM-Nail System41Medical AGSwitzerlandSubstantially Equivalent510(k) traditionalaccessdata.fda.gov
September 5, 2026K254135LipoSurg ARTISTNouvag AGSwitzerlandSubstantially Equivalent510(k) traditionalQPBaccessdata.fda.gov
August 28, 2026K253630Mpact 3D Metal FoamMedacta International S.A.SwitzerlandSubstantially Equivalent510(k) traditionalLPHaccessdata.fda.gov
August 20, 2026K261049SCALA® TLSpineart SASwitzerlandSubstantially Equivalent510(k) traditionalMAXaccessdata.fda.gov
August 14, 2026K262639BAGUERA® C Cervical Disc Surgical InstrumentsSpineart SASwitzerlandSubstantially Equivalent510(k) traditionalQLQaccessdata.fda.gov
August 14, 2026K253562medilogFDSchiller AGSwitzerlandSubstantially Equivalent510(k) traditionalMWJaccessdata.fda.gov
August 11, 2026K261398Dexter L6 SystemDistalmotion SASwitzerlandSubstantially Equivalent510(k) traditionalSDDaccessdata.fda.gov
July 29, 2026K261205SPINEART Navigation Instrument SystemSpineart SASwitzerlandSubstantially Equivalent510(k) traditionalOLOaccessdata.fda.gov
July 20, 2026K261535Hi-D Imaging 4TAVRHi-D Imaging AGSwitzerlandSubstantially Equivalent510(k) specialQIHaccessdata.fda.gov
June 29, 2026K261481Pangea Femur Reconstruction SystemStryker GmbHSwitzerlandSubstantially Equivalent510(k) traditionalHSBaccessdata.fda.gov
June 26, 2026K261351SALGINA 2.5mm Distal Radius SystemBonebridge AGSwitzerlandSubstantially Equivalent510(k) traditionalHRSaccessdata.fda.gov
June 20, 2026K260369Dynamis Robotic Surgical SystemLEM Surgical AGSwitzerlandSubstantially Equivalent510(k) traditionalOLOaccessdata.fda.gov
June 11, 2026K260653Dexter L6 SystemDistalmotion SASwitzerlandSubstantially Equivalent510(k) traditionalSDDaccessdata.fda.gov
June 10, 2026K261016MSS - Humeral reverse liners extensionMedacta International, SASwitzerlandSubstantially Equivalent510(k) traditionalPHXaccessdata.fda.gov
June 5, 2026K260761APTUS Clavicle System 2.8Medartis AGSwitzerlandSubstantially Equivalent510(k) traditionalHRSaccessdata.fda.gov
June 3, 2026K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGSwitzerlandSubstantially Equivalent510(k) traditionalKCTaccessdata.fda.gov
June 3, 2026K252904SIC Abutments including CAD/CAM SolutionsSic Invent AGSwitzerlandSubstantially Equivalent510(k) traditionalNHAaccessdata.fda.gov
June 2, 2026K260364Device 300419 StripGeistlich Pharma AGSwitzerlandSubstantially Equivalent510(k) traditionalMQVaccessdata.fda.gov
May 26, 2026K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARLSwitzerlandSubstantially Equivalent510(k) traditionalOLOaccessdata.fda.gov
May 20, 2026K260304WAVE PTA Balloon CatheterWAVE Medical AGSwitzerlandSubstantially Equivalent510(k) traditionalLITaccessdata.fda.gov
May 7, 2026K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AGSwitzerlandSubstantially Equivalent510(k) traditionalNHAaccessdata.fda.gov
May 5, 2026K254202MectaLIF 3D Metal AnteriorMedacta International S.A.SwitzerlandSubstantially Equivalent510(k) traditionalOVDaccessdata.fda.gov
May 1, 2026K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SASwitzerlandSubstantially Equivalent510(k) traditionalNKBaccessdata.fda.gov
April 28, 2026K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.SwitzerlandSubstantially Equivalent510(k) traditionalNKBaccessdata.fda.gov
April 24, 2026K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AGSwitzerlandSubstantially Equivalent510(k) traditionalHRSaccessdata.fda.gov
April 17, 2026K260934TITAN Nail; APTUS K-Wire SystemMedartis AGSwitzerlandSubstantially Equivalent510(k) specialHWCaccessdata.fda.gov
April 17, 2026K252334PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)PontemedagSwitzerlandSubstantially Equivalent510(k) traditionalKPIaccessdata.fda.gov
April 10, 2026K252757CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SASwitzerlandSubstantially Equivalent510(k) specialOPPaccessdata.fda.gov
April 9, 2026K254158SPINEART Navigation Instrument SystemSpineart SASwitzerlandSubstantially Equivalent510(k) specialOLOaccessdata.fda.gov
March 27, 2026K260294SF Push-in AnchorSurgical Fusion Technologies GmbHSwitzerlandSubstantially Equivalent510(k) traditionalMAIaccessdata.fda.gov
March 27, 2026K260240SYMPHONY Navigation Ready InstrumentsMedos International SARLSwitzerlandSubstantially Equivalent510(k) traditionalOLOaccessdata.fda.gov
March 19, 2026K260532Derma-GideGeistlich Pharma AGSwitzerlandSubstantially Equivalent510(k) specialKGNaccessdata.fda.gov
March 16, 2026K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AGSwitzerlandSubstantially Equivalent510(k) traditionalHRSaccessdata.fda.gov
March 10, 2026K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbHSwitzerlandSubstantially Equivalent510(k) traditionalHRSaccessdata.fda.gov
March 10, 2026K252168Straumann® BLC Implants - Indication WideningInstitut Straumann AGSwitzerlandSubstantially Equivalent510(k) traditionalDZEaccessdata.fda.gov
March 9, 2026K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbHSwitzerlandSubstantially Equivalent510(k) traditionalHRSaccessdata.fda.gov
March 2, 2026K254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating SystemSynthes GmbHSwitzerlandSubstantially Equivalent510(k) traditionalHRSaccessdata.fda.gov
February 26, 2026K260254Enbio PROEnbio Group AGSwitzerlandSubstantially Equivalent510(k) traditionalFLEaccessdata.fda.gov
February 26, 2026K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.SwitzerlandSubstantially Equivalent510(k) traditionalMBHaccessdata.fda.gov
February 3, 2026K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbHSwitzerlandSubstantially Equivalent510(k) traditionalHSBaccessdata.fda.gov
February 3, 2026K250644MSS - Monobloc stemMedacta International S.A.SwitzerlandSubstantially Equivalent510(k) traditionalPHXaccessdata.fda.gov
January 28, 2026K253388Sleepiz One+ (Model 2.5)Sleepiz AGSwitzerlandSubstantially Equivalent510(k) specialDRTaccessdata.fda.gov
January 28, 2026K253254GBT Machine Airflow Prophylaxis MasterE.M.S Electro Medical Systems S.ASwitzerlandSubstantially Equivalent510(k) traditionalELCaccessdata.fda.gov
January 28, 2026K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.SwitzerlandSubstantially Equivalent510(k) traditionalLPHaccessdata.fda.gov
January 22, 2026K253315Straumann Variobase Abutments XC for Bridge/BarInstitut Straumann AGSwitzerlandSubstantially Equivalent510(k) traditionalNHAaccessdata.fda.gov
January 22, 2026K251323Device 104 ParticulateGeistlich Pharma AGSwitzerlandSubstantially Equivalent510(k) traditionalKGNaccessdata.fda.gov
January 9, 2026K252847NextAR Hip PlatformMedacta International S.A.SwitzerlandSubstantially Equivalent510(k) traditionalSBFaccessdata.fda.gov
January 2, 2026K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AGSwitzerlandSubstantially Equivalent510(k) specialOWXaccessdata.fda.gov
December 19, 2025K253202Hoffmann LRF SystemStryker GmbHSwitzerlandSubstantially Equivalent510(k) traditionalKTTaccessdata.fda.gov
December 17, 2025K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AGSwitzerlandSubstantially Equivalent510(k) traditionalHRSaccessdata.fda.gov
December 12, 2025K253749Affixus® Natural Nail® Proximal Humeral SystemZimmer Switzerland Manufacturing GmbHSwitzerlandSubstantially Equivalent510(k) specialHSBaccessdata.fda.gov
December 5, 2025K252151els unibondSaremco Dental AGSwitzerlandSubstantially Equivalent510(k) traditionalKLEaccessdata.fda.gov
November 25, 2025K252253Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®Geistlich Pharma AGSwitzerlandSubstantially Equivalent510(k) traditionalNPLaccessdata.fda.gov
November 19, 2025K242603MyPAO SA guidesMedacta International S.A.SwitzerlandSubstantially Equivalent510(k) traditionalPBFaccessdata.fda.gov
November 14, 2025K250501System SophiThis AGSwitzerlandSubstantially Equivalent510(k) traditionalHQCaccessdata.fda.gov
November 12, 2025K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AGSwitzerlandSubstantially Equivalent510(k) traditionalNKGaccessdata.fda.gov
November 12, 2025K243715Synthes Patient Specific ImplantsSynthes GmbHSwitzerlandSubstantially Equivalent510(k) traditionalGXNaccessdata.fda.gov
October 31, 2025K250338MSS - Humeral reverse liners extensionMedacta International S.A.SwitzerlandSubstantially Equivalent510(k) traditionalPHXaccessdata.fda.gov
October 21, 2025K253249TriALTIS™ Spine SystemMedos International SARLSwitzerlandSubstantially Equivalent510(k) specialNKBaccessdata.fda.gov
September 30, 2025K251197Dexter L6 SystemDistalmotion SASwitzerlandSubstantially Equivalent510(k) traditionalSDDaccessdata.fda.gov
September 19, 2025K250450Coated hip implantsMedacta International S.A.SwitzerlandSubstantially Equivalent510(k) traditionalLZOaccessdata.fda.gov
September 18, 2025K251377Magic InBraMedela AGSwitzerlandSubstantially Equivalent510(k) traditionalHGXaccessdata.fda.gov
September 16, 2025K252540ACCUJECT Injector Set 2.1-1P (LP604590)Medicel AGSwitzerlandSubstantially Equivalent510(k) traditionalMSSaccessdata.fda.gov
September 12, 2025K252225PowerKnot High Strength SuturesMedacta International S.A.SwitzerlandSubstantially Equivalent510(k) traditionalGATaccessdata.fda.gov
September 4, 2025K251737NextAR(TM) Shoulder PlatformMedacta International S.A.SwitzerlandSubstantially Equivalent510(k) traditionalSBFaccessdata.fda.gov
August 28, 2025K243901SmartPilot YpsoMate NS-A2.25Ypsomed AGSwitzerlandSubstantially Equivalent510(k) traditionalQOGaccessdata.fda.gov
August 20, 2025K252104T1D1Comerge AGSwitzerlandSubstantially Equivalent510(k) traditionalNDCaccessdata.fda.gov
August 20, 2025K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbHSwitzerlandSubstantially Equivalent510(k) traditionalHSBaccessdata.fda.gov
August 14, 2025K251062Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte...Geistlich Pharma AGSwitzerlandSubstantially Equivalent510(k) traditionalNPLaccessdata.fda.gov
August 13, 2025K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbHSwitzerlandSubstantially Equivalent510(k) traditionalHSBaccessdata.fda.gov
August 13, 2025K243279DOLORCLAST Focused Shock WavesE.M.S Electro Medical Systems S.ASwitzerlandSubstantially Equivalent510(k) traditionalPZLaccessdata.fda.gov
August 12, 2025K250294Straumann® RidgeFit ImplantsInstitut Straumann AGSwitzerlandSubstantially Equivalent510(k) traditionalDZEaccessdata.fda.gov
August 7, 2025K243765LuMon(TM) SystemSentec AGSwitzerlandSubstantially Equivalent510(k) traditionalQEBaccessdata.fda.gov
July 31, 2025K250477NextAR(TM) SpineMedacta International S.A.SwitzerlandSubstantially Equivalent510(k) traditionalSBFaccessdata.fda.gov
July 31, 2025K241461Mpact Constrained LinerMedacta International S.A.SwitzerlandSubstantially Equivalent510(k) traditionalKWZaccessdata.fda.gov
July 29, 2025K251364Sleepiz One+ (2.5)Sleepiz AGSwitzerlandSubstantially Equivalent510(k) specialDRTaccessdata.fda.gov
July 24, 2025K251618MOTO Partial Knee System ExtensionMedacta International S.A.SwitzerlandSubstantially Equivalent510(k) traditionalHSXaccessdata.fda.gov
July 17, 2025K251556Device 300423 GranulesGeistlich Pharma AGSwitzerlandSubstantially Equivalent510(k) traditionalMQVaccessdata.fda.gov
July 17, 2025K251016MectaLIF 3D MetalMedacta International S.A.SwitzerlandSubstantially Equivalent510(k) traditionalMAXaccessdata.fda.gov
July 11, 2025K251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®Geistlich Pharma AGSwitzerlandSubstantially Equivalent510(k) specialNPMaccessdata.fda.gov
July 7, 2025K251863CustomSurg OrthoPlannerCustomsurg AGSwitzerlandSubstantially Equivalent510(k) traditionalLLZaccessdata.fda.gov
July 2, 2025K250415G0 Blood Pressure Monitoring System (G0)Aktiia SASwitzerlandSubstantially Equivalent510(k) traditionalDXNaccessdata.fda.gov
July 1, 2025K251933SnugFit ASA ExtensionMedacta International S.A.SwitzerlandSubstantially Equivalent510(k) specialMBIaccessdata.fda.gov
June 27, 2025K250969JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFASTDent4you AGSwitzerlandSubstantially Equivalent510(k) abbreviatedELWaccessdata.fda.gov
June 27, 2025K242988Genostis Osteosynthesis SystemGenostis AFSwitzerlandSubstantially Equivalent510(k) traditionalHRSaccessdata.fda.gov
June 26, 2025K251613SwissGraft XGeistlich Pharma AGSwitzerlandSubstantially Equivalent510(k) specialNPMaccessdata.fda.gov
June 18, 2025K242933SPINEART Navigation Instrument SystemSpineart SASwitzerlandSubstantially Equivalent510(k) traditionalOLOaccessdata.fda.gov
June 13, 2025K251166Mfinity Femoral SystemMedacta International S.A.SwitzerlandSubstantially Equivalent510(k) traditionalMEHaccessdata.fda.gov
June 11, 2025K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AGSwitzerlandSubstantially Equivalent510(k) traditionalHRSaccessdata.fda.gov
May 27, 2025K250435Dexter L6 SystemDistalmotion SASwitzerlandSubstantially Equivalent510(k) traditionalSDDaccessdata.fda.gov
April 23, 2025K243697MySpine WebPlannerMedacta International S.A.SwitzerlandSubstantially Equivalent510(k) traditionalLLZaccessdata.fda.gov
April 23, 2025K243326Dynamis Robotic Surgical SystemLEM Surgical AGSwitzerlandSubstantially Equivalent510(k) traditionalOLOaccessdata.fda.gov

Applicants with the most decisions

ApplicantDecisionsLatest
Medacta International S.A.23September 17, 2026
Geistlich Pharma AG10June 2, 2026
Institut Straumann AG9June 3, 2026
Spineart SA7August 20, 2026
Stryker GmbH5June 29, 2026
Bonebridge AG5June 26, 2026
Synthes GmbH5March 10, 2026
Distalmotion SA4August 11, 2026
Medartis AG4June 5, 2026
Medos International SARL4May 26, 2026
Cascination AG3October 23, 2026
Hi-D Imaging AG2July 20, 2026
LEM Surgical AG2June 20, 2026
Cequr SA2April 10, 2026
Sleepiz AG2January 28, 2026
E.M.S Electro Medical Systems S.A2January 28, 2026
ZuriMED Technologies AG2January 2, 2026
Icotec AG2November 12, 2025
Dent4you AG2June 27, 2025
Aesyra SA1October 30, 2026

By panel

PanelDecisionsLatest
Orthopedic52October 29, 2026
Dental21October 8, 2026
Neurology13October 30, 2026
Radiology10October 23, 2026
General, Plastic Surgery9September 5, 2026
General Hospital6June 3, 2026
Cardiovascular5August 14, 2026
Unknown3September 11, 2026
Ophthalmic2November 14, 2025
Anesthesiology2August 20, 2025
Physical Medicine1September 22, 2026
Gastroenterology, Urology1April 17, 2026
Obstetrics/Gynecology1September 18, 2025

By decision type

Decision typeDecisionsLatest
510(k) traditional108October 30, 2026
510(k) special17October 29, 2026
510(k) abbreviated1June 27, 2025

Where FDA publishes these decisions

CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission. 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.