# FDA device clearances in Spain: 54 since Nov 2024

Updated October 16, 2026.

FDA made 54 device decisions for applicants in Spain from November 20, 2024 to October 16, 2026: 54 510(k) clearances and De Novo grants and 0 PMA approvals and supplements, for 36 applicants. The newest, K262284 on October 16, 2026, is KIM BLUE from Desarrollo e Investigación Médica Aragonesa S.L..

## The full list

FDA device clearances for applicants in Spain: 54 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/spain

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: 54
- 510(k) and De Novo: 54
- PMA: 0
- Latest decision: October 16, 2026

## Newest decisions

The newest 54 of 54, 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 16, 2026 | K262284 | KIM BLUE | Desarrollo e Investigación Médica Aragonesa S.L. | Spain | Substantially Equivalent | 510(k) traditional | OTN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262284) |
| July 10, 2026 | K253480 | Capenergy C Equipments RF C200 and C400 Drakarian | Capenergy Medical S.L. | Spain | Substantially Equivalent | 510(k) abbreviated | PBX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253480) |
| July 2, 2026 | K260527 | FACE4D Aligner | Avinent Implant System S.L.U. | Spain | Substantially Equivalent | 510(k) traditional | NXC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260527) |
| July 1, 2026 | K261473 | Chromix | Termosalud S.L. | Spain | Substantially Equivalent | 510(k) traditional | OHS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261473) |
| June 29, 2026 | K253969 | ADAS 3D | Adas3D Medical S.L. | Spain | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253969) |
| June 27, 2026 | K253301 | BraiN20® (BraiN20) | Time IS Brain, S.L. | Spain | Substantially Equivalent | 510(k) traditional | GWF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253301) |
| June 13, 2026 | K261604 | Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) | Neuroelectrics Barcelona S.L.U. | Spain | Substantially Equivalent | 510(k) special | GWQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261604) |
| June 9, 2026 | K260564 | DESS Dental Smart Solutions | Terrats Medical SL | Spain | Substantially Equivalent | 510(k) traditional | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260564) |
| May 22, 2026 | K252784 | eXaSkin Plus | Anatomical Geometry S.L. | Spain | Substantially Equivalent | 510(k) traditional | MUJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252784) |
| May 4, 2026 | K253251 | Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and... | Leaseir Technologies, Slu | Spain | Substantially Equivalent | 510(k) traditional | GEX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253251) |
| April 16, 2026 | K253804 | DESS Dental Smart Solutions | Terrats Medical SL | Spain | Substantially Equivalent | 510(k) traditional | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253804) |
| April 14, 2026 | K252663 | Inbentus Versatile | Iconic Solutions by Murcia, SL | Spain | Substantially Equivalent | 510(k) traditional | CBK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252663) |
| April 13, 2026 | K253861 | ACORYS MAPPING SYSTEM | Corify Care S.L | Spain | Substantially Equivalent | 510(k) traditional | DQK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253861) |
| March 12, 2026 | K253636 | Zionic Pro Max (EMS) | Termosalud S.L. | Spain | Substantially Equivalent | 510(k) traditional | NGX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253636) |
| February 6, 2026 | K251577 | LAIA XR | Augmented Reality Software S.L. | Spain | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251577) |
| January 29, 2026 | K243732 | Multi-Unit DAS System | Talladium España, SL | Spain | Substantially Equivalent | 510(k) traditional | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243732) |
| January 22, 2026 | K253253 | IPDmilled Blanks | Implant Protesis Dental 2004, S.L. | Spain | Substantially Equivalent | 510(k) traditional | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253253) |
| January 6, 2026 | K253618 | QuadLock™ Fixation System | Abanza Tecnomed S.L | Spain | Substantially Equivalent | 510(k) traditional | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253618) |
| October 31, 2025 | K251547 | DESS Dental Smart Solutions | Terrats Medical SL | Spain | Substantially Equivalent | 510(k) traditional | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251547) |
| October 23, 2025 | K252384 | DESS® Dental Smart Solutions | Terrats Medical SL | Spain | Substantially Equivalent | 510(k) traditional | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252384) |
| October 9, 2025 | K252939 | COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS | Cotton High Tech S.L. | Spain | Substantially Equivalent | 510(k) special | HEB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252939) |
| September 29, 2025 | K253236 | G-BLOCK | Graphenano Dental S.L. | Spain | Substantially Equivalent | 510(k) abbreviated | EBF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253236) |
| September 5, 2025 | K251022 | 3D-SHAPER | 3D-Shaper Medical S.L | Spain | Substantially Equivalent | 510(k) traditional | KGI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251022) |
| August 20, 2025 | K251590 | Methinks CTA Stroke | Methinks Software, S.L | Spain | Substantially Equivalent | 510(k) traditional | QAS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251590) |
| August 20, 2025 | K251471 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | Spain | Substantially Equivalent | 510(k) traditional | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251471) |
| August 1, 2025 | K250495 | MINI VP1 (PL67\_F); MINI VP1 (PL61\_F) | Avizor S.A. | Spain | Substantially Equivalent | 510(k) traditional | LRX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250495) |
| July 23, 2025 | K251280 | DESS® Dental Implants | Terrats Medical SL | Spain | Substantially Equivalent | 510(k) traditional | DZE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251280) |
| July 23, 2025 | K250716 | IMAGE ONE | Infomed Software, S.L. | Spain | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250716) |
| July 22, 2025 | K243425 | Guided DAS Surgical Kit | Talladium España, SL | Spain | Substantially Equivalent | 510(k) traditional | KCT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243425) |
| July 21, 2025 | K251564 | microINR System | Iline Microsystems, S.L. | Spain | Substantially Equivalent | 510(k) traditional | GJS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251564) |
| June 16, 2025 | K250685 | Methinks NCCT Stroke | Methinks Software, S.L | Spain | Substantially Equivalent | 510(k) traditional | QAS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250685) |
| May 30, 2025 | K243530 | Dynamic TiBase | Talladium España, SL | Spain | Substantially Equivalent | 510(k) traditional | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243530) |
| May 28, 2025 | K243716 | Zionic Pro Max (Radiofrequency) | Termosalud S.L. | Spain | Substantially Equivalent | 510(k) traditional | PBX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243716) |
| May 22, 2025 | K250639 | DESS Dental Smart Solutions | Terrats Medical SL | Spain | Substantially Equivalent | 510(k) traditional | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250639) |
| May 14, 2025 | K242072 | CeraRoot TL Implant System (TL) | Ceraroot SL | Spain | Substantially Equivalent | 510(k) traditional | DZE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242072) |
| May 6, 2025 | K250160 | ANKYRAS | Mentice Spain S.L. | Spain | Substantially Equivalent | 510(k) traditional | PZO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250160) |
| April 16, 2025 | K241733 | HEBE (NP0000763) | Novasonix Technology S.L. | Spain | Substantially Equivalent | 510(k) traditional | PBX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241733) |
| March 18, 2025 | K242683 | QP-Prostate® CAD | Quibim S.L. | Spain | Substantially Equivalent | 510(k) traditional | QDQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242683) |
| March 7, 2025 | K241159 | Handbike Batec Electric | Batec Mobility, S.L. | Spain | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241159) |
| February 27, 2025 | K243543 | microINR System | Iline Microsystems, S.L. | Spain | Substantially Equivalent | 510(k) traditional | GJS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243543) |
| February 25, 2025 | K250238 | WasherCap™ Fixation System | Abanza Tecnomed S.L | Spain | Substantially Equivalent | 510(k) special | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250238) |
| February 19, 2025 | K242023 | Microdent Sterilization Cassette | Implant Microdent System S.L.U. | Spain | Substantially Equivalent | 510(k) traditional | KCT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242023) |
| February 14, 2025 | K243212 | DESS Dental Smart Solutions | Terrats Medical SL | Spain | Substantially Equivalent | 510(k) traditional | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243212) |
| February 12, 2025 | K243575 | ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls | Biokit, S.A. | Spain | Substantially Equivalent | 510(k) traditional | MYF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243575) |
| February 6, 2025 | K243488 | VMAT PRO | Termosalud | Spain | Substantially Equivalent | 510(k) traditional | ISA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243488) |
| January 30, 2025 | K243712 | WasherCap™ Mini Fixation System (Model 45) | Abanza Tecnomed S.L | Spain | Substantially Equivalent | 510(k) traditional | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243712) |
| January 24, 2025 | K241107 | Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia... | Indiba S. A. U. | Spain | Substantially Equivalent | 510(k) traditional | PBX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241107) |
| January 22, 2025 | K243139 | Reverso Pro System | Indiba S. A. U. | Spain | Substantially Equivalent | 510(k) traditional | GEI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243139) |
| December 20, 2024 | K242929 | Fas Aligner System | Xplora 3D Europe S.L | Spain | Substantially Equivalent | 510(k) traditional | NXC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242929) |
| December 19, 2024 | K242819 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | Spain | Substantially Equivalent | 510(k) traditional | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242819) |
| December 12, 2024 | K233152 | GENIOVA aligners | Geniova Technologies Sociedad Limitada | Spain | Substantially Equivalent | 510(k) traditional | NXC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233152) |
| December 6, 2024 | K240461 | OsteoSinter® EVANS and COTTON wedges and related accessories | Ames Medical Prosthetic Solutions, S.A.U. | Spain | Substantially Equivalent | 510(k) abbreviated | PLF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240461) |
| December 2, 2024 | K243232 | GripMate | Synthon Hispania S.L. | Spain | Substantially Equivalent | 510(k) traditional | KZH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243232) |
| November 20, 2024 | K243164 | INDIBA COMPACT devices | Indiba S. A. U. | Spain | Substantially Equivalent | 510(k) traditional | PBX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243164) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Terrats Medical SL | 7 | June 9, 2026 |
| Termosalud S.L. | 3 | July 1, 2026 |
| Talladium España, SL | 3 | January 29, 2026 |
| Implant Protesis Dental 2004, S.L. | 3 | January 22, 2026 |
| Abanza Tecnomed S.L | 3 | January 6, 2026 |
| Indiba S. A. U. | 3 | January 24, 2025 |
| Methinks Software, S.L | 2 | August 20, 2025 |
| Iline Microsystems, S.L. | 2 | July 21, 2025 |
| Desarrollo e Investigación Médica Aragonesa S.L. | 1 | October 16, 2026 |
| Capenergy Medical S.L. | 1 | July 10, 2026 |
| Avinent Implant System S.L.U. | 1 | July 2, 2026 |
| Adas3D Medical S.L. | 1 | June 29, 2026 |
| Time IS Brain, S.L. | 1 | June 27, 2026 |
| Neuroelectrics Barcelona S.L.U. | 1 | June 13, 2026 |
| Anatomical Geometry S.L. | 1 | May 22, 2026 |
| Leaseir Technologies, Slu | 1 | May 4, 2026 |
| Iconic Solutions by Murcia, SL | 1 | April 14, 2026 |
| Corify Care S.L | 1 | April 13, 2026 |
| Augmented Reality Software S.L. | 1 | February 6, 2026 |
| Cotton High Tech S.L. | 1 | October 9, 2025 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Dental](https://specstream.ai/data/fda-clearances/panel/dental) | 17 | July 2, 2026 |
| [General, Plastic Surgery](https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery) | 9 | October 16, 2026 |
| [Radiology](https://specstream.ai/data/fda-clearances/panel/radiology) | 9 | June 29, 2026 |
| [Orthopedic](https://specstream.ai/data/fda-clearances/panel/orthopedic) | 4 | January 6, 2026 |
| [Physical Medicine](https://specstream.ai/data/fda-clearances/panel/physical-medicine) | 3 | March 12, 2026 |
| [General Hospital](https://specstream.ai/data/fda-clearances/panel/general-hospital) | 3 | July 22, 2025 |
| [Neurology](https://specstream.ai/data/fda-clearances/panel/neurology) | 2 | June 27, 2026 |
| [Hematology](https://specstream.ai/data/fda-clearances/panel/hematology) | 2 | July 21, 2025 |
| [Anesthesiology](https://specstream.ai/data/fda-clearances/panel/anesthesiology) | 1 | April 14, 2026 |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 1 | April 13, 2026 |
| [Obstetrics/Gynecology](https://specstream.ai/data/fda-clearances/panel/obstetrics-gynecology) | 1 | October 9, 2025 |
| [Ophthalmic](https://specstream.ai/data/fda-clearances/panel/ophthalmic) | 1 | August 1, 2025 |
| [Microbiology](https://specstream.ai/data/fda-clearances/panel/microbiology) | 1 | February 12, 2025 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 48 | October 16, 2026 |
| [510(k) abbreviated](https://specstream.ai/data/fda-clearances/decision/510k-abbreviated) | 3 | July 10, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 3 | June 13, 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/).