# FDA device clearances in Belgium: 27 since Nov 2024

Updated October 9, 2026.

FDA made 27 device decisions for applicants in Belgium from December 13, 2024 to October 9, 2026: 27 510(k) clearances and De Novo grants and 0 PMA approvals and supplements, for 18 applicants. The newest, K260913 on October 9, 2026, is CMF Titanium Splints from Materialise NV.

## The full list

FDA device clearances for applicants in Belgium: 27 rows for $5, 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 1 row 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.

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

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: 27
- 510(k) and De Novo: 27
- PMA: 0
- Latest decision: October 9, 2026

## Newest decisions

The newest 27 of 27, 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 9, 2026 | K260913 | CMF Titanium Splints | Materialise NV | Belgium | Substantially Equivalent | 510(k) traditional | DZJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260913) |
| October 9, 2026 | K260096 | Wishbone HAE | Wishbone SA | Belgium | Substantially Equivalent | 510(k) traditional | NPM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260096) |
| October 2, 2026 | K262412 | Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630) | Barco NV | Belgium | Substantially Equivalent | 510(k) special | PGY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262412) |
| September 30, 2026 | K261469 | Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where “x” may be any numeric character). | Barco N.V. | Belgium | Substantially Equivalent | 510(k) traditional | DXJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261469) |
| September 22, 2026 | K262442 | HipStudio Analysis | Replasia BV | Belgium | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262442) |
| June 9, 2026 | K260802 | Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV | Belgium | Substantially Equivalent | 510(k) traditional | QHE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260802) |
| April 10, 2026 | K252708 | Relu Cloud | Relu BV | Belgium | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252708) |
| March 12, 2026 | K251964 | Mimics Thoracic Planner | Materialise NV | Belgium | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251964) |
| February 13, 2026 | K252565 | PreOp v3 | Clouds of Care | Belgium | Substantially Equivalent | 510(k) special | OLX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252565) |
| February 13, 2026 | K252400 | Endomina EZFuse system | Endo Tools Therapeutics S.A. | Belgium | Substantially Equivalent | 510(k) traditional | OCW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252400) |
| January 7, 2026 | K253308 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic... | Materialise NV | Belgium | Substantially Equivalent | 510(k) special | PPT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253308) |
| January 6, 2026 | K253793 | Materialise TKA Guide System | Materialise NV | Belgium | Substantially Equivalent | 510(k) special | JWH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253793) |
| November 25, 2025 | K250635 | FEops HEARTguide Simulation Application | Feops NV | Belgium | Substantially Equivalent | 510(k) traditional | QQI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250635) |
| November 17, 2025 | K252086 | DTX Studio Assist | Nobel Biocare C/O Medicim NV | Belgium | Substantially Equivalent | 510(k) traditional | MYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252086) |
| October 15, 2025 | K252199 | AGFA HealthCare Enterprise Imaging | Agfa Healthcare N.V. | Belgium | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252199) |
| September 30, 2025 | K250050 | miDiagnostics HSV-1&2 CSF Test | Midiagnostics NV | Belgium | Substantially Equivalent | 510(k) traditional | PGH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250050) |
| August 29, 2025 | K250874 | Sunrise | Sunrise SA | Belgium | Substantially Equivalent | 510(k) traditional | QRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250874) |
| July 14, 2025 | K251554 | Materialise TKA Guide System | Materialise NV | Belgium | Substantially Equivalent | 510(k) traditional | JWH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251554) |
| July 8, 2025 | K251447 | K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) | Terumo Europe N.V. | Belgium | Substantially Equivalent | 510(k) traditional | FMI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251447) |
| May 30, 2025 | K242640 | FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin | Fertipro NV | Belgium | Substantially Equivalent | 510(k) traditional | MQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242640) |
| May 29, 2025 | K243309 | 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) | Terumo Europe N.V. | Belgium | Substantially Equivalent | 510(k) special | FMI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243309) |
| May 12, 2025 | K243509 | Archer PSI System | 3D-Side | Belgium | Substantially Equivalent | 510(k) traditional | QHE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243509) |
| April 4, 2025 | K243581 | K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) | Terumo Europe N.V. | Belgium | Substantially Equivalent | 510(k) traditional | FMI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243581) |
| February 21, 2025 | K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery | Materialise NV | Belgium | Substantially Equivalent | 510(k) traditional | DZJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243637) |
| January 17, 2025 | DEN230051 | Myocene | Myocene | Belgium | Unknown | De Novo | SDX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN230051) |
| January 3, 2025 | K241283 | Elemental Granulate | Zinkh NV | Belgium | Substantially Equivalent | 510(k) traditional | OLR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241283) |
| December 13, 2024 | K243307 | LCD Monitor (MDEC-2523) | Barco N.V. | Belgium | Substantially Equivalent | 510(k) traditional | GCJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243307) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Materialise NV | 7 | October 9, 2026 |
| Terumo Europe N.V. | 3 | July 8, 2025 |
| Barco N.V. | 2 | September 30, 2026 |
| Wishbone SA | 1 | October 9, 2026 |
| Barco NV | 1 | October 2, 2026 |
| Replasia BV | 1 | September 22, 2026 |
| Relu BV | 1 | April 10, 2026 |
| Clouds of Care | 1 | February 13, 2026 |
| Endo Tools Therapeutics S.A. | 1 | February 13, 2026 |
| Feops NV | 1 | November 25, 2025 |
| Nobel Biocare C/O Medicim NV | 1 | November 17, 2025 |
| Agfa Healthcare N.V. | 1 | October 15, 2025 |
| Midiagnostics NV | 1 | September 30, 2025 |
| Sunrise SA | 1 | August 29, 2025 |
| Fertipro NV | 1 | May 30, 2025 |
| 3D-Side | 1 | May 12, 2025 |
| Myocene | 1 | January 17, 2025 |
| Zinkh NV | 1 | January 3, 2025 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Radiology](https://specstream.ai/data/fda-clearances/panel/radiology) | 6 | October 2, 2026 |
| [Orthopedic](https://specstream.ai/data/fda-clearances/panel/orthopedic) | 4 | June 9, 2026 |
| [Dental](https://specstream.ai/data/fda-clearances/panel/dental) | 3 | October 9, 2026 |
| [Neurology](https://specstream.ai/data/fda-clearances/panel/neurology) | 3 | February 13, 2026 |
| [General Hospital](https://specstream.ai/data/fda-clearances/panel/general-hospital) | 3 | July 8, 2025 |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 2 | September 30, 2026 |
| [Gastroenterology, Urology](https://specstream.ai/data/fda-clearances/panel/gastroenterology-urology) | 2 | February 13, 2026 |
| [Microbiology](https://specstream.ai/data/fda-clearances/panel/microbiology) | 1 | September 30, 2025 |
| [Ear, Nose, Throat](https://specstream.ai/data/fda-clearances/panel/ear-nose-throat) | 1 | August 29, 2025 |
| [Obstetrics/Gynecology](https://specstream.ai/data/fda-clearances/panel/obstetrics-gynecology) | 1 | May 30, 2025 |
| Unknown | 1 | January 3, 2025 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 21 | October 9, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 5 | October 2, 2026 |
| [De Novo](https://specstream.ai/data/fda-clearances/decision/de-novo) | 1 | January 17, 2025 |

## 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/).