Medos International Sarl
FDA Regulatory Profile
Summary
- Total Recalls
- 1 (1 Class I)
- 510(k) Clearances
- 94
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1284-2024 | Class I | CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; | February 2, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253249 | TriALTIS Spine System | October 21, 2025 |
| K243249 | TriALTIS Spine System | January 17, 2025 |
| K241893 | CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays | September 16, 2024 |
| K242042 | TriALTIS Spine System | September 9, 2024 |
| K233684 | TriALTIS Spine System | December 12, 2023 |
| K233366 | SYMPHONY OCT System | November 9, 2023 |
| K232492 | 2.7 mm GRYPHON Flex Knotless PEEK Anchor; 2.7 mm GRYPHON Flex Knotless Biocomposite Anchor | October 6, 2023 |
| K231479 | TriALTIS Spine System | September 22, 2023 |
| K223438 | TELIGEN System Peripheral Motor Nerve Stimulation Indications | February 10, 2023 |
| K223108 | TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) | January 19, 2023 |
| K213978 | TELIGEN System | October 18, 2022 |
| K221325 | CONDUIT Lateral Switch Plate | August 25, 2022 |
| K220040 | CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform Xtr | July 14, 2022 |
| K221364 | Mitek TIGHT-N Anchor | July 11, 2022 |
| K212756 | Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set | May 5, 2022 |
| K220219 | PERMALOOP Suture, PERMATAPE Suture | April 26, 2022 |
| K214025 | PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter | April 12, 2022 |
| K220374 | EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws) | March 8, 2022 |
| K210838 | PROWLER SELECT PLUS; PROWLER EX | August 25, 2021 |
| K211344 | MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery | May 28, 2021 |