# FDA device clearances in Austria: 25 since Nov 2024

Updated July 31, 2026.

FDA made 25 device decisions for applicants in Austria from January 10, 2025 to July 31, 2026: 25 510(k) clearances and De Novo grants and 0 PMA approvals and supplements, for 17 applicants. The newest, K253655 on July 31, 2026, is Angled Screwdriver MED (M-SD090) from W&H Dentalwerk Bürmoos GmbH.

## The full list

FDA device clearances for applicants in Austria: 25 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. 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/austria

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: 25
- 510(k) and De Novo: 25
- PMA: 0
- Latest decision: July 31, 2026

## Newest decisions

The newest 25 of 25, 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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| July 31, 2026 | K253655 | Angled Screwdriver MED (M-SD090) | W&H Dentalwerk Bürmoos GmbH | Austria | Substantially Equivalent | 510(k) traditional | DZI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253655) |
| June 29, 2026 | K260918 | Zolid Lunaris | Amann Girrbach AG | Austria | Substantially Equivalent | 510(k) traditional | EIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260918) |
| June 18, 2026 | K253776 | Implantmed Plus II & Piezomed Plus II Module | W&H Dentalwerk Buermoos GmbH | Austria | Substantially Equivalent | 510(k) traditional | DZI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253776) |
| June 16, 2026 | K260958 | I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S.... | I.T.S. GmbH | Austria | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260958) |
| April 24, 2026 | K260054 | I.T.S. PRS Phoenix II | I.T.S. GmbH | Austria | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260054) |
| April 22, 2026 | K253256 | myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) | Otto Bock Healthcare Products GmbH | Austria | Substantially Equivalent | 510(k) traditional | GXY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253256) |
| April 3, 2026 | K260720 | mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING... | MED-EL Elektromedizinische Geräte GmbH | Austria | Substantially Equivalent | 510(k) special | ETB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260720) |
| April 3, 2026 | K260719 | mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis... | MED-EL Elektromedizinische Geräte GmbH | Austria | Substantially Equivalent | 510(k) special | ETA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260719) |
| April 3, 2026 | K260718 | mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial... | MED-EL Elektromedizinische Geräte GmbH | Austria | Substantially Equivalent | 510(k) special | ETB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260718) |
| December 19, 2025 | K252284 | eMurmur Heart AI | Csd Labs | Austria | Substantially Equivalent | 510(k) traditional | DQD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252284) |
| August 19, 2025 | K250313 | Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs... | Harps Europe Manufacturing GmbH | Austria | Substantially Equivalent | 510(k) abbreviated | KGO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250313) |
| July 22, 2025 | K243415 | Granudacyn® Wound Irrigation Solution | P.G.F. Industry Solutions GmbH | Austria | Substantially Equivalent | 510(k) traditional | FRO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243415) |
| July 3, 2025 | K243280 | Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips)... | W&H Dentalwerk Buermoos GmbH | Austria | Substantially Equivalent | 510(k) traditional | ERL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243280) |
| June 30, 2025 | K250484 | PIUR tUS inside | Piur Imaging GmbH | Austria | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250484) |
| May 30, 2025 | K243522 | ViVi® Toga Premium | Thi Total Healthcare Innovation GmbH | Austria | Substantially Equivalent | 510(k) traditional | FYA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243522) |
| April 25, 2025 | K243821 | i-Cut | A.M.I. Agency For Medical Innovations GmbH | Austria | Substantially Equivalent | 510(k) traditional | HET | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243821) |
| April 25, 2025 | K243041 | contact forte Alpha | Bhm-Tech Produktionsgesellschaft Mbh | Austria | Substantially Equivalent | 510(k) traditional | LXB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243041) |
| April 21, 2025 | K251196 | Composite Orthodontic Brackets and Buttons | Ec Certification Service GmbH | Austria | Substantially Equivalent | 510(k) traditional | DYW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251196) |
| April 11, 2025 | K250748 | KLAXON (TWIST); KLAXON (TWIST R) | Klaxon-Mobility GmbH | Austria | Substantially Equivalent | 510(k) special | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250748) |
| March 28, 2025 | K234067 | ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) | Medphoton GmbH | Austria | Substantially Equivalent | 510(k) traditional | OWB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234067) |
| February 28, 2025 | K242179 | Synea Fusion Handpieces (Intensiv & Profin) | W&H Dentalwerk Bürmoos GmbH | Austria | Substantially Equivalent | 510(k) traditional | EFB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242179) |
| January 17, 2025 | K241269 | mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit | MED-EL Elektromedizinische Geräte GmbH | Austria | Substantially Equivalent | 510(k) traditional | ETA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241269) |
| January 17, 2025 | K241261 | mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial... | MED-EL Elektromedizinische Geräte GmbH | Austria | Substantially Equivalent | 510(k) traditional | ETB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241261) |
| January 17, 2025 | K241142 | mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis | MED-EL Elektromedizinische Geräte GmbH | Austria | Substantially Equivalent | 510(k) traditional | ETB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241142) |
| January 10, 2025 | K240267 | Klaxon (Twist); Klaxon (Twist R) | Klaxon Mobility GmbH | Austria | Substantially Equivalent | 510(k) traditional | ITI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240267) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| MED-EL Elektromedizinische Geräte GmbH | 6 | April 3, 2026 |
| W&H Dentalwerk Bürmoos GmbH | 2 | July 31, 2026 |
| W&H Dentalwerk Buermoos GmbH | 2 | June 18, 2026 |
| I.T.S. GmbH | 2 | June 16, 2026 |
| Amann Girrbach AG | 1 | June 29, 2026 |
| Otto Bock Healthcare Products GmbH | 1 | April 22, 2026 |
| Csd Labs | 1 | December 19, 2025 |
| Harps Europe Manufacturing GmbH | 1 | August 19, 2025 |
| P.G.F. Industry Solutions GmbH | 1 | July 22, 2025 |
| Piur Imaging GmbH | 1 | June 30, 2025 |
| Thi Total Healthcare Innovation GmbH | 1 | May 30, 2025 |
| A.M.I. Agency For Medical Innovations GmbH | 1 | April 25, 2025 |
| Bhm-Tech Produktionsgesellschaft Mbh | 1 | April 25, 2025 |
| Ec Certification Service GmbH | 1 | April 21, 2025 |
| Klaxon-Mobility GmbH | 1 | April 11, 2025 |
| Medphoton GmbH | 1 | March 28, 2025 |
| Klaxon Mobility GmbH | 1 | January 10, 2025 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Ear, Nose, Throat](https://specstream.ai/data/fda-clearances/panel/ear-nose-throat) | 8 | April 3, 2026 |
| [Dental](https://specstream.ai/data/fda-clearances/panel/dental) | 5 | July 31, 2026 |
| [Orthopedic](https://specstream.ai/data/fda-clearances/panel/orthopedic) | 2 | June 16, 2026 |
| [General, Plastic Surgery](https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery) | 2 | August 19, 2025 |
| [Radiology](https://specstream.ai/data/fda-clearances/panel/radiology) | 2 | June 30, 2025 |
| [Physical Medicine](https://specstream.ai/data/fda-clearances/panel/physical-medicine) | 2 | April 11, 2025 |
| [Neurology](https://specstream.ai/data/fda-clearances/panel/neurology) | 1 | April 22, 2026 |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 1 | December 19, 2025 |
| Unknown | 1 | July 22, 2025 |
| [Obstetrics/Gynecology](https://specstream.ai/data/fda-clearances/panel/obstetrics-gynecology) | 1 | April 25, 2025 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 20 | July 31, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 4 | April 3, 2026 |
| [510(k) abbreviated](https://specstream.ai/data/fda-clearances/decision/510k-abbreviated) | 1 | August 19, 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/).