# FDA device clearances in France: 154 since Nov 2024

Updated October 29, 2026.

FDA made 154 device decisions for applicants in France from November 14, 2024 to October 29, 2026: 154 510(k) clearances and De Novo grants and 0 PMA approvals and supplements, for 90 applicants. The newest, K260337 on October 29, 2026, is SEEG-Tx® System (STX-SYS-001) from Dixi Medical.

## The full list

FDA device clearances for applicants in France: 154 rows for $7.70, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. Columns: Number, Pathway, Device name, Applicant, Applicant address, Contact, Decision, Decision date, Decision type, Date received, Product code, Device type, Device class, Panel, Applicant state, Applicant country, Supplement reason, Read on, Source. The new rows each week by email, about 5 rows a month: $19 a month. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (contact, pathway, device name, applicant address, date received, device type and 5 more), which open on your screen as soon as the payment clears and come by email. The rows on this page are a sample.

Buy: https://specstream.ai/data/fda-clearances/country/france

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.

- Decisions: 154
- 510(k) and De Novo: 154
- PMA: 0
- Latest decision: October 29, 2026

## Newest decisions

The newest 100 of 154, 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 date | Number | Device | Applicant | Location | Decision | Type | Product code | Source |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| October 29, 2026 | K260337 | SEEG-Tx® System (STX-SYS-001) | Dixi Medical | France | Substantially Equivalent | 510(k) traditional | GXD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260337) |
| October 26, 2026 | K262567 | GPS Ankle | Blue Ortho | France | Substantially Equivalent | 510(k) traditional | OLO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262567) |
| October 20, 2026 | K262062 | CINA-Aneurysm | Avicenna.Ai | France | Substantially Equivalent | 510(k) traditional | QBS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262062) |
| October 19, 2026 | K262147 | CINA-Aneurysm+ | Avicenna.Ai | France | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262147) |
| October 16, 2026 | K262443 | Transorb™ Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030) | Sofradim Production | France | Substantially Equivalent | 510(k) traditional | OWT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262443) |
| September 28, 2026 | K262649 | Alians Forearm | Newclip Technics | France | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262649) |
| September 21, 2026 | K254280 | F.A.S.T Screw | Steps Ortho | France | Substantially Equivalent | 510(k) traditional | HWC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254280) |
| September 14, 2026 | K260781 | Yumizen H550 | Horiba Abx Sas | France | Substantially Equivalent | 510(k) traditional | GKZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260781) |
| September 9, 2026 | K252486 | ChestView US (1.1) | Gleamer | France | Substantially Equivalent | 510(k) traditional | MYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252486) |
| September 4, 2026 | K262828 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.m.a.i.o | France | Substantially Equivalent | 510(k) special | NKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262828) |
| August 28, 2026 | K261378 | Rayvolve AZchest | AZmed | France | Substantially Equivalent | 510(k) traditional | QBS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261378) |
| August 17, 2026 | K261500 | KBA3D (v2.4.0) | S.m.a.i.o | France | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261500) |
| August 3, 2026 | K260381 | Eve | Wandercraft SAS | France | Substantially Equivalent | 510(k) traditional | PHL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260381) |
| July 28, 2026 | K261511 | Xpert Ankle | Newclip Technics | France | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261511) |
| July 22, 2026 | K261113 | Op.n™ Spine Navigation and Robotic Guidance | Ecential Robotics | France | Substantially Equivalent | 510(k) traditional | OLO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261113) |
| July 22, 2026 | K254296 | Ossiclear (Ossiclear System) | Sounduct | France | Substantially Equivalent | 510(k) traditional | LXB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254296) |
| July 21, 2026 | K253770 | CardIQ Suite | GE Medical Systems SCS | France | Substantially Equivalent | 510(k) traditional | JAK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253770) |
| July 8, 2026 | K261191 | Alians Elbow S | Newclip Technics | France | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261191) |
| July 1, 2026 | K253802 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.m.a.i.o | France | Substantially Equivalent | 510(k) special | NKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253802) |
| June 26, 2026 | K260714 | MammoScreen® (5) | Therapixel | France | Substantially Equivalent | 510(k) special | QDQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260714) |
| June 12, 2026 | K252937 | ThinkQA 3 | Dosisoft SA | France | Substantially Equivalent | 510(k) traditional | IYE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252937) |
| June 10, 2026 | K253115 | LARS ACJ | Movmedix S.A.S. | France | Substantially Equivalent | 510(k) traditional | HTN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253115) |
| June 9, 2026 | K260748 | ES-Series | E-Scopics | France | Substantially Equivalent | 510(k) traditional | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260748) |
| June 8, 2026 | K261352 | 2D Hip Planning Software | One Ortho | France | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261352) |
| June 5, 2026 | K253108 | VEOFIX Snap Off Screw | Steps Ortho | France | Substantially Equivalent | 510(k) traditional | HWC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253108) |
| June 4, 2026 | K261519 | Sonio Suspect | Sonio | France | Substantially Equivalent | 510(k) special | POK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261519) |
| June 3, 2026 | K260780 | HeartFocus | Deski | France | Substantially Equivalent | 510(k) special | QJU | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260780) |
| May 29, 2026 | K261038 | Xpert PFP | Newclip Technics | France | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261038) |
| May 27, 2026 | K261374 | LigaPASS™ System | Medicrea International S.A.S | France | Substantially Equivalent | 510(k) special | OWI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261374) |
| May 21, 2026 | K253956 | ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) | Sofradim Production | France | Substantially Equivalent | 510(k) traditional | FTL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253956) |
| May 15, 2026 | K261289 | UNiD™ Spine Analyzer (SW3002) | Medicrea International S.A.S. (Medtronic) | France | Substantially Equivalent | 510(k) special | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261289) |
| May 12, 2026 | K260378 | Rayvolve | AZmed | France | Substantially Equivalent | 510(k) traditional | QBS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260378) |
| May 11, 2026 | K252880 | Pytheas Your Guided Trajectory | Pytheas Navigation Sas | France | Substantially Equivalent | 510(k) traditional | OLO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252880) |
| April 29, 2026 | K260589 | ES-Series | E-Scopics | France | Substantially Equivalent | 510(k) special | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260589) |
| April 24, 2026 | K253805 | Knee+ | Pixee Medical S.A.S. | France | Substantially Equivalent | 510(k) traditional | SBF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253805) |
| April 22, 2026 | K260150 | LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) | Nooance | France | Substantially Equivalent | 510(k) traditional | OHS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260150) |
| April 21, 2026 | K260447 | ETEST Gepotidacin (GEP) (0.016-256 µg/mL) | bioMérieux SA | France | Substantially Equivalent | 510(k) traditional | JWY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260447) |
| April 15, 2026 | K254107 | Refobacin Bone Cement R (110034355) | Biomet France | France | Substantially Equivalent | 510(k) traditional | LOD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254107) |
| April 10, 2026 | K252241 | Pressio 3 Multi-parameter Neuromonitoring System | Sophysa | France | Substantially Equivalent | 510(k) traditional | GWM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252241) |
| April 3, 2026 | K260786 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.m.a.i.o | France | Substantially Equivalent | 510(k) special | NKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260786) |
| April 3, 2026 | K253674 | Blueprint Patient-Specific Instrumentation | Stryker Corporation (Tornier, S.A.S.) | France | Substantially Equivalent | 510(k) traditional | PHX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253674) |
| March 30, 2026 | K253950 | Avatar Medical Vision | Avatar Medical | France | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253950) |
| March 25, 2026 | K260274 | Airlock® Ankle Plating System | Novastep SAS | France | Substantially Equivalent | 510(k) abbreviated | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260274) |
| March 24, 2026 | K260087 | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright | GE Medical Systems SCS | France | Substantially Equivalent | 510(k) traditional | MUE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260087) |
| March 16, 2026 | K252433 | Sonio Detect (v3) | Sonio | France | Substantially Equivalent | 510(k) traditional | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252433) |
| March 12, 2026 | K253734 | Taurus Clip | Taurus Endoscopy | France | Substantially Equivalent | 510(k) traditional | PKL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253734) |
| March 11, 2026 | K253906 | Xpert Hand | Newclip Technics | France | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253906) |
| February 26, 2026 | K254017 | SWINGO-3D Lumbar Cage System | Implanet | France | Substantially Equivalent | 510(k) traditional | MAX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254017) |
| February 6, 2026 | K251507 | INTEGRE LIO | Quantel Medical | France | Substantially Equivalent | 510(k) traditional | HQF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251507) |
| February 6, 2026 | K251474 | Median LCS (internal name) / eyonis LCS (trade name) (1.0) | Median Technologies | France | Substantially Equivalent | 510(k) traditional | QDQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251474) |
| January 23, 2026 | K252957 | Pneumo Dissector Hook | Ab Medica Sas | France | Substantially Equivalent | 510(k) traditional | GCJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252957) |
| January 16, 2026 | K252767 | actiTENS mini | Sublimed | France | Substantially Equivalent | 510(k) traditional | GZJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252767) |
| January 9, 2026 | K254003 | JARVIS Metaphyseal Stem | FH Industrie | France | Substantially Equivalent | 510(k) special | PHX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254003) |
| January 7, 2026 | K253990 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.m.a.i.o | France | Substantially Equivalent | 510(k) special | NKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253990) |
| January 7, 2026 | K253924 | PuraStat | 3-D Matrix Europe SAS | France | Substantially Equivalent | 510(k) special | QAU | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253924) |
| January 7, 2026 | K253923 | PuraStat | 3-D Matrix Europe SAS | France | Substantially Equivalent | 510(k) special | PHN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253923) |
| December 23, 2025 | K253122 | Sim&Size | Sim&Cure | France | Substantially Equivalent | 510(k) traditional | PZO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253122) |
| December 23, 2025 | K253091 | ART-Plan+ (v3.1.0) | Therapanacea Sas | France | Substantially Equivalent | 510(k) traditional | MUJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253091) |
| December 19, 2025 | K253577 | IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) | Medicrea International S.A.S. (Medtronic) | France | Substantially Equivalent | 510(k) special | MAX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253577) |
| December 19, 2025 | K251152 | DBLG2 | Diabeloop | France | Substantially Equivalent | 510(k) traditional | QJI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251152) |
| December 17, 2025 | K253721 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.m.a.i.o | France | Substantially Equivalent | 510(k) special | NKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253721) |
| December 16, 2025 | K253118 | Companion Spine DIAM™ Instrumentation | Companion Spine France | France | Substantially Equivalent | 510(k) traditional | QLR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253118) |
| December 9, 2025 | K251199 | Allia Moveo | GE Medical Systems SCS | France | Substantially Equivalent | 510(k) traditional | OWB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251199) |
| December 8, 2025 | K252294 | Fetal EchoScan (v1.2) | Brightheart | France | Substantially Equivalent | 510(k) traditional | POK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252294) |
| December 4, 2025 | K250679 | FFX Facet Fixation System | Sc Medica | France | Substantially Equivalent | 510(k) traditional | MRW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250679) |
| November 28, 2025 | K250636 | Sophy Mini Monopressure Valve (SM1) | Sophysa | France | Substantially Equivalent | 510(k) traditional | JXG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250636) |
| November 25, 2025 | K251550 | NX01 (NX01) | Naox Technologies Sas | France | Substantially Equivalent | 510(k) traditional | OMC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251550) |
| November 14, 2025 | K251078 | AutoDensity | Eos Imaging | France | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251078) |
| November 10, 2025 | K252474 | Withings BeamO (SCT02) | Withings | France | Substantially Equivalent | 510(k) traditional | DPS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252474) |
| October 29, 2025 | K253345 | JARVIS Diaphyseal Stem Standard | FH Industrie | France | Substantially Equivalent | 510(k) special | PHX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253345) |
| October 24, 2025 | K253125 | Parietene™ Flat Sheet Mesh | Medtronic - Sofradim Production | France | Substantially Equivalent | 510(k) special | FTL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253125) |
| October 24, 2025 | K250904 | Atalante X | Wandercraft SAS | France | Substantially Equivalent | 510(k) traditional | PHL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250904) |
| October 20, 2025 | K252665 | brAIn™ Shoulder Positioning | Avatar Medical | France | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252665) |
| October 16, 2025 | K252153 | FFX Facet Fixation System | Sc Medica | France | Substantially Equivalent | 510(k) traditional | MRW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252153) |
| October 7, 2025 | K252851 | deepLive (OSP12 + DMS) | Damae Medical | France | Substantially Equivalent | 510(k) special | NQQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252851) |
| October 1, 2025 | K250767 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | France | Substantially Equivalent | 510(k) traditional | PBF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250767) |
| September 12, 2025 | K251518 | Volta AF-Xplorer II | Volta Medical | France | Substantially Equivalent | 510(k) traditional | DQK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251518) |
| September 12, 2025 | K251368 | FETOLY | Diagnoly | France | Substantially Equivalent | 510(k) traditional | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251368) |
| September 8, 2025 | K251957 | Coaptium Connect with Tissium Light | Tissium SA | France | Substantially Equivalent | 510(k) special | SFD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251957) |
| September 4, 2025 | K250353 | Oniris; Oniris Plus | Oniris | France | Substantially Equivalent | 510(k) traditional | LRK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250353) |
| August 29, 2025 | K250290 | SurgiTwin | Twinsight | France | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250290) |
| August 29, 2025 | K243859 | PRAEVAorta®2 | Nurea | France | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243859) |
| August 28, 2025 | K252437 | JAZZ Spinal System | Implanet | France | Substantially Equivalent | 510(k) special | NKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252437) |
| August 28, 2025 | K252411 | JARVIS Glenoid Reverse Shoulder Prosthesis | FH Industrie | France | Substantially Equivalent | 510(k) special | PHX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252411) |
| August 25, 2025 | K243680 | Neurovascular Insight V1.0 | Olea Medical S.A.S. | France | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243680) |
| August 22, 2025 | K243685 | MammoScreen BD | Therapixel | France | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243685) |
| August 15, 2025 | K251747 | VEA Align; spineEOS | Eos Imaging | France | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251747) |
| August 12, 2025 | K243562 | CuffGuard | Idmed | France | Substantially Equivalent | 510(k) traditional | BSK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243562) |
| August 7, 2025 | K251629 | UNiD™ Spine Analyzer | Medicrea International S.A.S. (Medtronic) | France | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251629) |
| August 6, 2025 | K250569 | Cardiologs Holter Platform | Philips France Commercial | France | Substantially Equivalent | 510(k) traditional | DPS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250569) |
| August 1, 2025 | K243427 | QuickSleeper 5 | Dentalhitec | France | Substantially Equivalent | 510(k) traditional | EGM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243427) |
| July 23, 2025 | K243681 | Neuro Insight V1.0 | Olea Medical S.A.S. | France | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243681) |
| July 8, 2025 | K251804 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.m.a.i.o | France | Substantially Equivalent | 510(k) special | NKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251804) |
| July 7, 2025 | K243884 | TAVIPILOT | Caranx Medical | France | Substantially Equivalent | 510(k) traditional | OWB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243884) |
| July 3, 2025 | K243679 | MammoScreen® (4) | Therapixel | France | Substantially Equivalent | 510(k) traditional | QDQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243679) |
| June 30, 2025 | K250022 | HeroTracker Sense | Voluntis | France | Substantially Equivalent | 510(k) traditional | CAF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250022) |
| June 27, 2025 | K250984 | Maestro System (REF100) | Moon Surgical | France | Substantially Equivalent | 510(k) traditional | QZB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250984) |
| June 26, 2025 | K251632 | Optimas MAX System | InMode , Ltd. | France | Substantially Equivalent | 510(k) special | GEX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251632) |
| June 23, 2025 | K251570 | Hippocampe Marathon and Trail | Vipamat Sarl | France | Substantially Equivalent | 510(k) traditional | IQC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251570) |
| June 23, 2025 | K243339 | WiTOF | Idmed | France | Substantially Equivalent | 510(k) traditional | KOI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243339) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Newclip Technics | 8 | September 28, 2026 |
| S.m.a.i.o | 7 | September 4, 2026 |
| GE Medical Systems SCS | 6 | July 21, 2026 |
| Brightheart | 5 | December 8, 2025 |
| Sofradim Production | 4 | October 16, 2026 |
| AZmed | 4 | August 28, 2026 |
| FH Industrie | 4 | January 9, 2026 |
| Therapixel | 3 | June 26, 2026 |
| Sonio | 3 | June 4, 2026 |
| Medicrea International S.A.S. (Medtronic) | 3 | May 15, 2026 |
| Sophysa | 3 | April 10, 2026 |
| Avatar Medical | 3 | March 30, 2026 |
| 3-D Matrix Europe SAS | 3 | January 7, 2026 |
| Avicenna.Ai | 2 | October 20, 2026 |
| Steps Ortho | 2 | September 21, 2026 |
| Wandercraft SAS | 2 | August 3, 2026 |
| Ecential Robotics | 2 | July 22, 2026 |
| Dosisoft SA | 2 | June 12, 2026 |
| E-Scopics | 2 | June 9, 2026 |
| Deski | 2 | June 3, 2026 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Radiology](https://specstream.ai/data/fda-clearances/panel/radiology) | 55 | October 20, 2026 |
| [Orthopedic](https://specstream.ai/data/fda-clearances/panel/orthopedic) | 35 | September 28, 2026 |
| [Neurology](https://specstream.ai/data/fda-clearances/panel/neurology) | 15 | October 29, 2026 |
| [General, Plastic Surgery](https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery) | 9 | October 16, 2026 |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 7 | November 10, 2025 |
| [Gastroenterology, Urology](https://specstream.ai/data/fda-clearances/panel/gastroenterology-urology) | 5 | March 12, 2026 |
| [Microbiology](https://specstream.ai/data/fda-clearances/panel/microbiology) | 4 | April 21, 2026 |
| Unknown | 4 | January 7, 2026 |
| [General Hospital](https://specstream.ai/data/fda-clearances/panel/general-hospital) | 4 | June 9, 2025 |
| [Physical Medicine](https://specstream.ai/data/fda-clearances/panel/physical-medicine) | 3 | August 3, 2026 |
| [Dental](https://specstream.ai/data/fda-clearances/panel/dental) | 3 | September 4, 2025 |
| [Anesthesiology](https://specstream.ai/data/fda-clearances/panel/anesthesiology) | 3 | August 12, 2025 |
| [Ear, Nose, Throat](https://specstream.ai/data/fda-clearances/panel/ear-nose-throat) | 2 | July 22, 2026 |
| [Hematology](https://specstream.ai/data/fda-clearances/panel/hematology) | 1 | September 14, 2026 |
| [Ophthalmic](https://specstream.ai/data/fda-clearances/panel/ophthalmic) | 1 | February 6, 2026 |
| [Clinical Chemistry](https://specstream.ai/data/fda-clearances/panel/clinical-chemistry) | 1 | December 19, 2025 |
| [Immunology](https://specstream.ai/data/fda-clearances/panel/immunology) | 1 | June 12, 2025 |
| [Pathology](https://specstream.ai/data/fda-clearances/panel/pathology) | 1 | May 14, 2025 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 121 | October 29, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 30 | September 4, 2026 |
| [De Novo](https://specstream.ai/data/fda-clearances/decision/de-novo) | 2 | June 17, 2025 |
| [510(k) abbreviated](https://specstream.ai/data/fda-clearances/decision/510k-abbreviated) | 1 | March 25, 2026 |

## Where FDA publishes these decisions

- [FDA 510(k) database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm)
- [FDA PMA database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm)
- [openFDA device API](https://open.fda.gov/apis/device/)

Source: [openFDA device 510(k) and PMA (U.S. Food and Drug Administration)](https://open.fda.gov/apis/device/). 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](https://creativecommons.org/licenses/by/4.0/).