Data / Medical devices / Austria / A.M.I. Agency For Medical Innovations GMBH
A.M.I. Agency For Medical Innovations GMBH: FDA-registered device maker in Feldkirch Vorarlberg, Austria, 5 510(k) clearances
A.M.I. Agency For Medical Innovations GMBH is registered with the FDA (registration 3005049530) in Feldkirch Vorarlberg, Austria. It lists 8 device types. The FDA files 5 510(k) clearances under its listings, the newest dated April 25, 2025. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3005049530
- Address
- Im Letten 1, Feldkirch Vorarlberg, Austria, 6800
- Owner or operator
- AGENCY FOR MEDICAL INNOVATIONS GMBH (9068871)
- Roles
- Manufacturer
- First device listed
- July 25, 2008
- Registered through
- 2027
- Brand names listed
- A.M.I. HAL / RAR System, A.M.I. HAL Handle, A.M.I. HAL Knotpusher, A.M.I. HAL Knotpusher / AHK 007, A.M.I. HAL Needleholder, A.M.I. HAL Needleholder / AHN 006, A.M.I. HAL-Doppler II System, A.M.I. HAL-II Adaptor USA and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Carrier, Ligature | GEJ | 1 | Manufacturer | accessdata.fda.gov |
| Catheter, Pediatric, General & Plastic Surgery | GBN | 1 | Manufacturer | accessdata.fda.gov |
| Containment System, Laparoscopic Power Morcellation, With Instrument Port | PMU | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Ligature Passing And Knot Tying | HCF | 1 | Manufacturer | accessdata.fda.gov |
| Laparoscope, Gynecologic (And Accessories) | HET | 2 | Manufacturer | accessdata.fda.gov |
| Ligator, Hemorrhoidal | FHN | 2 | Manufacturer | accessdata.fda.gov |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | 1 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 25, 2025 | K243821 | i-Cut | HET | Substantially Equivalent | A.M.I. Agency For Medical Innovations GmbH | accessdata.fda.gov |
| November 10, 2021 | K212659 | More-Cell-System | PMU | Substantially Equivalent | Agency For Medical Innovations GmbH | accessdata.fda.gov |
| December 7, 2018 | K182664 | FiXcision | KOA | Substantially Equivalent | Agency For Medical Innovations GmbH | accessdata.fda.gov |
| June 12, 2015 | K150718 | Wi-3 HAL-RAR System | FHN | Substantially Equivalent | Agency For Medical Innovations GmbH | accessdata.fda.gov |
| August 7, 2006 | K061831 | MEDCHANNEL HTS SYSTEM | IYN | Substantially Equivalent | Medchannel, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Containment System, Laparoscopic Power Morcellation, With Instrument Port
- All makers of Laparoscope, Gynecologic (And Accessories)
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of Catheter, Pediatric, General & Plastic Surgery
- All makers of Ligator, Hemorrhoidal
- All makers of Surgical Instruments, G-U, Manual (And Accessories)
Updated April 25, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.