# FDA device clearances in Denmark: 41 since Nov 2024

Updated September 30, 2026.

FDA made 41 device decisions for applicants in Denmark from December 6, 2024 to September 30, 2026: 41 510(k) clearances and De Novo grants and 0 PMA approvals and supplements, for 21 applicants. The newest, K261327 on September 30, 2026, is Elos Accurate Hybrid Base from Elos Medtech Pinol A/S.

## The full list

FDA device clearances for applicants in Denmark: 41 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 3 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.

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

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: 41
- 510(k) and De Novo: 41
- PMA: 0
- Latest decision: September 30, 2026

## Newest decisions

The newest 41 of 41, 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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| September 30, 2026 | K261327 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | Denmark | Substantially Equivalent | 510(k) traditional | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261327) |
| September 22, 2026 | K262390 | BoneXpert | Visiana | Denmark | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262390) |
| September 16, 2026 | K261400 | Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large | Ambu A/S | Denmark | Substantially Equivalent | 510(k) traditional | FDS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261400) |
| September 16, 2026 | K260309 | Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set | Ambu A/S | Denmark | Substantially Equivalent | 510(k) traditional | EOQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260309) |
| August 13, 2026 | K261499 | TrachFlush | Aw Technologies Aps | Denmark | Substantially Equivalent | 510(k) traditional | BSK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261499) |
| July 24, 2026 | K260192 | DIANA | ROPCA ApS | Denmark | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260192) |
| July 14, 2026 | K260578 | Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup... | Ambu A/S | Denmark | Substantially Equivalent | 510(k) traditional | GXY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260578) |
| July 14, 2026 | K253667 | Accoat Guide Wire | Sp Medical A/S | Denmark | Substantially Equivalent | 510(k) traditional | DQX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253667) |
| June 25, 2026 | K254108 | Jabra Enhance Select Self-fit (Jabra Enhance Select 550) | GN Hearing A/S | Denmark | Substantially Equivalent | 510(k) traditional | QUH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254108) |
| June 22, 2026 | K260316 | CMN Capillary Function with Oncology Virtual Expert | Cercare Medical A/S | Denmark | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260316) |
| June 18, 2026 | K260190 | ARTHUR | ROPCA ApS | Denmark | Substantially Equivalent | 510(k) traditional | IYO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260190) |
| June 11, 2026 | K253607 | UNEEG EpiSight System | Uneeg Medical A/S | Denmark | Substantially Equivalent | 510(k) traditional | SEM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253607) |
| May 22, 2026 | K260189 | MagVenture Accelerated TMS (aTMS) Therapy System | Tonica Elektronik A/S | Denmark | Substantially Equivalent | 510(k) traditional | OBP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260189) |
| May 20, 2026 | K253774 | Elos Accurate® Denture Fixation System | Elos Medtech Pinol A/S | Denmark | Substantially Equivalent | 510(k) traditional | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253774) |
| May 18, 2026 | K253831 | CMN Capillary Function with Virtual Expert for MRI, CT and CBCT | Cercare Medical A/S | Denmark | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253831) |
| May 1, 2026 | K252488 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | Denmark | Substantially Equivalent | 510(k) traditional | CGA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252488) |
| May 1, 2026 | K252475 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | Denmark | Substantially Equivalent | 510(k) traditional | JGS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252475) |
| April 30, 2026 | K251583 | Ambu® Virobac II® Exhalation Filter | Ambu A/S | Denmark | Substantially Equivalent | 510(k) traditional | CAH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251583) |
| April 24, 2026 | K260988 | °M Warmer System with °M Station | Mequ A/S | Denmark | Substantially Equivalent | 510(k) special | LGZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260988) |
| April 10, 2026 | K260082 | TRIOS Dx (R1) | 3Shape TRIOS A/S | Denmark | Substantially Equivalent | 510(k) traditional | SHQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260082) |
| April 10, 2026 | K252207 | ABL90 FLEX PLUS System, safeCLINITUBES | Radiometer Medicals Aps | Denmark | Substantially Equivalent | 510(k) traditional | CHL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252207) |
| November 9, 2025 | K251596 | Lunderquist Extra Stiff Wire Guide | William Cook Europe Aps | Denmark | Substantially Equivalent | 510(k) special | DQX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251596) |
| October 16, 2025 | K251497 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | Denmark | Substantially Equivalent | 510(k) traditional | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251497) |
| August 11, 2025 | K251125 | MagVenture TMS Therapy System | Tonica Elektronik A/S | Denmark | Substantially Equivalent | 510(k) traditional | OBP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251125) |
| August 8, 2025 | K251119 | MagVenture TMS Therapy System | Tonica Elektronik A/S | Denmark | Substantially Equivalent | 510(k) traditional | OBP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251119) |
| July 30, 2025 | K252032 | T65 (9016E061-) | Tonica Elektronik A/S | Denmark | Substantially Equivalent | 510(k) special | OBP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252032) |
| June 11, 2025 | K251499 | Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova... | William Cook Europe Aps | Denmark | Substantially Equivalent | 510(k) special | BTR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251499) |
| June 11, 2025 | K250269 | Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection) | Ambu A/S | Denmark | Substantially Equivalent | 510(k) traditional | FAJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250269) |
| April 24, 2025 | K250262 | GO-PEN® | Go-Pen Aps | Denmark | Substantially Equivalent | 510(k) traditional | FMF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250262) |
| April 4, 2025 | K242103 | TRIOS Ready Tip | 3Shape TRIOS A/S | Denmark | Substantially Equivalent | 510(k) traditional | NBL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242103) |
| April 1, 2025 | K250189 | AdvaTx | Advalight Aps | Denmark | Substantially Equivalent | 510(k) traditional | GEX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250189) |
| February 14, 2025 | K242198 | ICS Dizcovery (1091) | Natus Medical Denmark Aps | Denmark | Substantially Equivalent | 510(k) traditional | GWN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242198) |
| February 14, 2025 | K241958 | WARD-CSS (v1.2.x) | Ward 24/7 Aps | Denmark | Substantially Equivalent | 510(k) traditional | MWI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241958) |
| January 31, 2025 | K241348 | SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) | Motilitycount Aps | Denmark | Substantially Equivalent | 510(k) traditional | MQK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241348) |
| January 14, 2025 | K241037 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | Denmark | Substantially Equivalent | 510(k) traditional | CEM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241037) |
| December 23, 2024 | K242948 | Adora DRFi (04550010) | Nrt X-Ray A/S | Denmark | Substantially Equivalent | 510(k) traditional | JAA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242948) |
| December 18, 2024 | K241132 | ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) | Artsmedia Denmark Aps | Denmark | Substantially Equivalent | 510(k) traditional | MQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241132) |
| December 18, 2024 | K241095 | ARTSMedia Semen Wash Medium | Artsmedia Denmark Aps | Denmark | Substantially Equivalent | 510(k) traditional | MQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241095) |
| December 13, 2024 | K240998 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | Denmark | Substantially Equivalent | 510(k) traditional | CHL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240998) |
| December 10, 2024 | K242025 | Elos Accurate® Hybrid Base™ | Elos Medtech Pinol A/S | Denmark | Substantially Equivalent | 510(k) traditional | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242025) |
| December 6, 2024 | K241989 | Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert | Cercare Medical A/S | Denmark | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241989) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Ambu A/S | 5 | September 16, 2026 |
| Radiometer Medicals Aps | 5 | May 1, 2026 |
| Elos Medtech Pinol A/S | 4 | September 30, 2026 |
| Tonica Elektronik A/S | 4 | May 22, 2026 |
| Cercare Medical A/S | 3 | June 22, 2026 |
| ROPCA ApS | 2 | July 24, 2026 |
| 3Shape TRIOS A/S | 2 | April 10, 2026 |
| William Cook Europe Aps | 2 | November 9, 2025 |
| Artsmedia Denmark Aps | 2 | December 18, 2024 |
| Visiana | 1 | September 22, 2026 |
| Aw Technologies Aps | 1 | August 13, 2026 |
| Sp Medical A/S | 1 | July 14, 2026 |
| GN Hearing A/S | 1 | June 25, 2026 |
| Uneeg Medical A/S | 1 | June 11, 2026 |
| Mequ A/S | 1 | April 24, 2026 |
| Go-Pen Aps | 1 | April 24, 2025 |
| Advalight Aps | 1 | April 1, 2025 |
| Natus Medical Denmark Aps | 1 | February 14, 2025 |
| Ward 24/7 Aps | 1 | February 14, 2025 |
| Motilitycount Aps | 1 | January 31, 2025 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Radiology](https://specstream.ai/data/fda-clearances/panel/radiology) | 7 | September 22, 2026 |
| [Neurology](https://specstream.ai/data/fda-clearances/panel/neurology) | 7 | July 14, 2026 |
| [Dental](https://specstream.ai/data/fda-clearances/panel/dental) | 6 | September 30, 2026 |
| [Clinical Chemistry](https://specstream.ai/data/fda-clearances/panel/clinical-chemistry) | 5 | May 1, 2026 |
| [Anesthesiology](https://specstream.ai/data/fda-clearances/panel/anesthesiology) | 3 | August 13, 2026 |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 3 | July 14, 2026 |
| [Obstetrics/Gynecology](https://specstream.ai/data/fda-clearances/panel/obstetrics-gynecology) | 3 | January 31, 2025 |
| [Gastroenterology, Urology](https://specstream.ai/data/fda-clearances/panel/gastroenterology-urology) | 2 | September 16, 2026 |
| [Ear, Nose, Throat](https://specstream.ai/data/fda-clearances/panel/ear-nose-throat) | 2 | September 16, 2026 |
| [General Hospital](https://specstream.ai/data/fda-clearances/panel/general-hospital) | 2 | April 24, 2026 |
| [General, Plastic Surgery](https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery) | 1 | April 1, 2025 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 37 | September 30, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 4 | April 24, 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/).