# FDA device clearances in Sweden: 54 since Nov 2024

Updated September 22, 2026.

FDA made 54 device decisions for applicants in Sweden from December 6, 2024 to September 22, 2026: 54 510(k) clearances and De Novo grants and 0 PMA approvals and supplements, for 30 applicants. The newest, K254240 on September 22, 2026, is Echo-2 from Neko Health AB.

## The full list

FDA device clearances for applicants in Sweden: 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 4 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/sweden

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: September 22, 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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| September 22, 2026 | K254240 | Echo-2 | Neko Health AB | Sweden | Substantially Equivalent | 510(k) traditional | QOK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254240) |
| September 11, 2026 | K254051 | Extroducer Infusion Catheter System | SmartWise Sweden AB | Sweden | Substantially Equivalent | 510(k) traditional | KRA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254051) |
| September 8, 2026 | K261987 | Reusable SmartPeg | Osstell AB | Sweden | Substantially Equivalent | 510(k) traditional | EKX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261987) |
| September 8, 2026 | K253988 | LiteSet Trays | Nobel Biocare AB | Sweden | Substantially Equivalent | 510(k) traditional | KCT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253988) |
| August 26, 2026 | K261142 | Ponto 5 Mini; Ponto 5 Superpower | Oticon Medical AB | Sweden | Substantially Equivalent | 510(k) special | MAH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261142) |
| August 26, 2026 | K253715 | Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm... | Maquet Critical Care AB | Sweden | Substantially Equivalent | 510(k) traditional | PIF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253715) |
| August 6, 2026 | K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment... | Nobel Biocare AB | Sweden | Substantially Equivalent | 510(k) traditional | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253999) |
| August 5, 2026 | K261932 | Leksell® Vantage Stereotactic System | Elekta Solutions AB | Sweden | Substantially Equivalent | 510(k) traditional | HAW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261932) |
| July 31, 2026 | K253835 | Affinity | Hermes Medical Solutions AB | Sweden | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253835) |
| July 23, 2026 | K261644 | Perfadex Plus | Xvivo Perfusion AB | Sweden | Substantially Equivalent | 510(k) traditional | KDN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261644) |
| July 17, 2026 | K261658 | LoFric Origo Pro Coudé | Wellspect AB | Sweden | Substantially Equivalent | 510(k) special | EZD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261658) |
| July 17, 2026 | K253694 | Natural Cycles | Natural Cycles Nordic AB | Sweden | Substantially Equivalent | 510(k) traditional | PYT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253694) |
| July 1, 2026 | K261852 | OTS Hip | Ortoma AB | Sweden | Substantially Equivalent | 510(k) special | OLO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261852) |
| June 25, 2026 | K253367 | EliA CTD 13 Screen | Phadia AB | Sweden | Substantially Equivalent | 510(k) traditional | LLL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253367) |
| June 17, 2026 | K253055 | Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”) | Nordic Kinetics AB | Sweden | Substantially Equivalent | 510(k) traditional | GYD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253055) |
| May 22, 2026 | K261098 | TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric... | Senzime AB | Sweden | Substantially Equivalent | 510(k) special | KOI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261098) |
| May 22, 2026 | K254129 | Spectrum-2 | Neko Health AB | Sweden | Substantially Equivalent | 510(k) traditional | MUD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254129) |
| May 20, 2026 | K253911 | Derma-2 | Neko Health AB | Sweden | Substantially Equivalent | 510(k) traditional | LHQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253911) |
| May 12, 2026 | K252731 | Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant | Promimic AB | Sweden | Substantially Equivalent | 510(k) traditional | DZE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252731) |
| April 24, 2026 | K260999 | LoFric Elle Pro | Wellspect AB | Sweden | Substantially Equivalent | 510(k) special | EZD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260999) |
| April 15, 2026 | K253573 | ASTar BC G- Kit | Q-Linea AB | Sweden | Substantially Equivalent | 510(k) traditional | SAN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253573) |
| February 19, 2026 | K252002 | Monaco RTP System (6.3) | Elekta Solutions AB | Sweden | Substantially Equivalent | 510(k) traditional | MUJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252002) |
| February 18, 2026 | K252197 | Nobel Biocare S Series Implants | Nobel Biocare AB | Sweden | Substantially Equivalent | 510(k) traditional | DZE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252197) |
| February 6, 2026 | DEN250006 | Amferia Wound Dressing | Amferia AB | Sweden | Unknown | De Novo | SHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250006) |
| January 15, 2026 | K252188 | EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony)... | Elekta Solutions AB | Sweden | Substantially Equivalent | 510(k) traditional | IYE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252188) |
| December 22, 2025 | K252109 | RayStation (2024A SP3) | RaySearch Laboratories AB (PUBL) | Sweden | Substantially Equivalent | 510(k) traditional | MUJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252109) |
| October 24, 2025 | K252238 | CoroFlow Cardiovascular System | Coroventis Research AB | Sweden | Substantially Equivalent | 510(k) traditional | DQK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252238) |
| October 24, 2025 | K251710 | Mobile X-ray unit (!M1) | Solutions For Tomorrow AB | Sweden | Substantially Equivalent | 510(k) traditional | IZL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251710) |
| October 8, 2025 | K251363 | ProKnow DS | Elekta Solutions AB | Sweden | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251363) |
| September 26, 2025 | K250659 | LoFric Origo | Wellspect AB | Sweden | Substantially Equivalent | 510(k) traditional | EZD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250659) |
| September 24, 2025 | K252183 | Resitu Slider 09 (RESL09) | Resitu Medical AB | Sweden | Substantially Equivalent | 510(k) traditional | KNW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252183) |
| September 9, 2025 | K252477 | Hybrid Viewer (00859873006240) | Hermes Medical Solutions AB | Sweden | Substantially Equivalent | 510(k) special | KPS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252477) |
| September 4, 2025 | K251298 | Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4)... | Clinical Laserthermia Systems, AB | Sweden | Substantially Equivalent | 510(k) traditional | ONO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251298) |
| August 25, 2025 | K243834 | NobelZygoma TiUltra Implant system | Nobel Biocare AB | Sweden | Substantially Equivalent | 510(k) traditional | DZE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243834) |
| July 30, 2025 | K243919 | Voxel Dosimetry (00859873006226) | Hermes Medical Solutions AB | Sweden | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243919) |
| July 23, 2025 | K243373 | Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF... | Vitrolife Sweden AB | Sweden | Substantially Equivalent | 510(k) traditional | MQF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243373) |
| July 2, 2025 | K250391 | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) | Elekta Solutions AB | Sweden | Substantially Equivalent | 510(k) traditional | IWB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250391) |
| June 27, 2025 | K250522 | Multi4 System | Multi4 Medical AB | Sweden | Substantially Equivalent | 510(k) traditional | FAS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250522) |
| May 20, 2025 | K242485 | EveryWare | Breas Medical AB | Sweden | Substantially Equivalent | 510(k) traditional | MOD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242485) |
| May 16, 2025 | K250086 | OTS Hip | Ortoma AB | Sweden | Substantially Equivalent | 510(k) traditional | OLO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250086) |
| May 16, 2025 | K242438 | Clearo | Breas Medical AB | Sweden | Substantially Equivalent | 510(k) traditional | NHJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242438) |
| May 6, 2025 | K241980 | !M1 | Solutions For Tomorrow AB | Sweden | Substantially Equivalent | 510(k) traditional | IZL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241980) |
| April 28, 2025 | K250977 | Suture-TOOL System | Suturion AB | Sweden | Substantially Equivalent | 510(k) special | NEW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250977) |
| April 17, 2025 | K242992 | RayCare (2024A SP1) | RaySearch Laboratories AB (PUBL) | Sweden | Substantially Equivalent | 510(k) traditional | MUJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242992) |
| April 4, 2025 | K240398 | RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 | RaySearch Laboratories AB (PUBL) | Sweden | Substantially Equivalent | 510(k) traditional | MUJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240398) |
| March 21, 2025 | K250561 | Natural Cycles | Natural Cycles Nordic AB | Sweden | Substantially Equivalent | 510(k) special | PYT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250561) |
| February 27, 2025 | K242128 | Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) | Xaga Surgical | Sweden | Substantially Equivalent | 510(k) traditional | KNW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242128) |
| January 22, 2025 | K242835 | Suture-TOOL System | Suturion AB | Sweden | Substantially Equivalent | 510(k) traditional | NEW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242835) |
| January 17, 2025 | K243291 | Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) | Neoventa Medical AB | Sweden | Substantially Equivalent | 510(k) traditional | HGP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243291) |
| January 13, 2025 | K233452 | Vivo 45 LS | Breas Medical AB | Sweden | Substantially Equivalent | 510(k) traditional | NOU | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233452) |
| January 3, 2025 | K240346 | NobelProcera Zirconia Implant Bridge | Nobel Biocare AB | Sweden | Substantially Equivalent | 510(k) traditional | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240346) |
| December 13, 2024 | K240779 | Vivo 3 | Breas Medical AB | Sweden | Substantially Equivalent | 510(k) traditional | MNT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240779) |
| December 13, 2024 | K240778 | Vivo 1, Vivo 2 | Breas Medical AB | Sweden | Substantially Equivalent | 510(k) traditional | MNS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240778) |
| December 6, 2024 | K242524 | SyMRI | Syntheticmr AB (Publ.) | Sweden | Substantially Equivalent | 510(k) traditional | LNH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242524) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Nobel Biocare AB | 5 | September 8, 2026 |
| Elekta Solutions AB | 5 | August 5, 2026 |
| Breas Medical AB | 5 | May 20, 2025 |
| Neko Health AB | 3 | September 22, 2026 |
| Hermes Medical Solutions AB | 3 | July 31, 2026 |
| Wellspect AB | 3 | July 17, 2026 |
| RaySearch Laboratories AB (PUBL) | 3 | December 22, 2025 |
| Natural Cycles Nordic AB | 2 | July 17, 2026 |
| Ortoma AB | 2 | July 1, 2026 |
| Solutions For Tomorrow AB | 2 | October 24, 2025 |
| Suturion AB | 2 | April 28, 2025 |
| SmartWise Sweden AB | 1 | September 11, 2026 |
| Osstell AB | 1 | September 8, 2026 |
| Oticon Medical AB | 1 | August 26, 2026 |
| Maquet Critical Care AB | 1 | August 26, 2026 |
| Xvivo Perfusion AB | 1 | July 23, 2026 |
| Phadia AB | 1 | June 25, 2026 |
| Nordic Kinetics AB | 1 | June 17, 2026 |
| Senzime AB | 1 | May 22, 2026 |
| Promimic AB | 1 | May 12, 2026 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Radiology](https://specstream.ai/data/fda-clearances/panel/radiology) | 13 | July 31, 2026 |
| [Gastroenterology, Urology](https://specstream.ai/data/fda-clearances/panel/gastroenterology-urology) | 8 | August 26, 2026 |
| [Dental](https://specstream.ai/data/fda-clearances/panel/dental) | 6 | September 8, 2026 |
| [Anesthesiology](https://specstream.ai/data/fda-clearances/panel/anesthesiology) | 6 | May 22, 2026 |
| [Obstetrics/Gynecology](https://specstream.ai/data/fda-clearances/panel/obstetrics-gynecology) | 5 | July 17, 2026 |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 4 | September 22, 2026 |
| [Neurology](https://specstream.ai/data/fda-clearances/panel/neurology) | 4 | August 5, 2026 |
| [General, Plastic Surgery](https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery) | 4 | February 6, 2026 |
| [General Hospital](https://specstream.ai/data/fda-clearances/panel/general-hospital) | 1 | September 8, 2026 |
| [Ear, Nose, Throat](https://specstream.ai/data/fda-clearances/panel/ear-nose-throat) | 1 | August 26, 2026 |
| [Immunology](https://specstream.ai/data/fda-clearances/panel/immunology) | 1 | June 25, 2026 |
| [Microbiology](https://specstream.ai/data/fda-clearances/panel/microbiology) | 1 | April 15, 2026 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 45 | September 22, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 8 | August 26, 2026 |
| [De Novo](https://specstream.ai/data/fda-clearances/decision/de-novo) | 1 | February 6, 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/).