TELIGEN
Model 286006064S · Medos International Sàrl · DI 10705034604541
HRX — Arthroscope · Class II · 21 CFR 888.1100
LXH — Orthopedic Manual Surgical Instrument · Class I · 21 CFR 888.4540
UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 5.44 |
| 2019-02 | 0 | 2.57 |
| 2019-03 | 0 | 2.67 |
| 2019-04 | 0 | 2.63 |
| 2019-05 | 0 | 2.77 |
| 2019-06 | 0 | 2.67 |
| 2019-07 | 0 | 2.66 |
| 2019-08 | 0 | 2.75 |
| 2019-09 | 0 | 3.16 |
| 2019-10 | 0 | 2.66 |
| 2019-11 | 0 | 2.83 |
| 2019-12 | 0 | 2.9 |
| 2020-01 | 0 | 3.02 |
| 2020-02 | 0 | 2.96 |
| 2020-03 | 0 | 2.87 |
| 2020-04 | 0 | 2.96 |
| 2020-05 | 0 | 2.68 |
| 2020-06 | 0 | 3.38 |
| 2020-07 | 0 | 4.16 |
| 2020-08 | 0 | 3.88 |
| 2020-09 | 0 | 4.55 |
| 2020-10 | 0 | 5.18 |
| 2020-11 | 0 | 4.2 |
| 2020-12 | 0 | 4.89 |
| 2021-01 | 0 | 4.4 |
| 2021-02 | 0 | 4.23 |
| 2021-03 | 0 | 4.42 |
| 2021-04 | 0 | 4.26 |
| 2021-05 | 0 | 3.71 |
| 2021-06 | 0 | 3.67 |
| 2021-07 | 0 | 3.17 |
| 2021-08 | 0 | 3.7 |
| 2021-09 | 0 | 2.92 |
| 2021-10 | 0 | 3.14 |
| 2021-11 | 0 | 3.27 |
| 2021-12 | 0 | 3.21 |
| 2022-01 | 0 | 3.02 |
| 2022-02 | 0 | 3.26 |
| 2022-03 | 0 | 3.48 |
| 2022-04 | 0 | 3.68 |
| 2022-05 | 0 | 3.8 |
| 2022-06 | 0 | 3.14 |
| 2022-07 | 0 | 2.79 |
| 2022-08 | 0 | 2.96 |
| 2022-09 | 0 | 3.14 |
| 2022-10 | 0 | 3.31 |
| 2022-11 | 0 | 3.9 |
| 2022-12 | 0 | 3.98 |
| 2023-01 | 0 | 4.69 |
| 2023-02 | 0 | 3.39 |
| 2023-03 | 0 | 4.04 |
| 2023-04 | 0 | 3.52 |
| 2023-05 | 0 | 3.59 |
| 2023-06 | 0 | 3.59 |
| 2023-07 | 0 | 3.25 |
| 2023-08 | 0 | 3.42 |
| 2023-09 | 0 | 2.94 |
| 2023-10 | 0 | 2.95 |
| 2023-11 | 0 | 4.36 |
| 2023-12 | 0 | 4.71 |
| 2024-01 | 0 | 3.7 |
| 2024-02 | 0 | 3.85 |
| 2024-03 | 0 | 3.37 |
| 2024-04 | 0 | 4.17 |
| 2024-05 | 0 | 4.44 |
| 2024-06 | 0 | 4.62 |
| 2024-07 | 0 | 3.29 |
| 2024-08 | 0 | 3.22 |
| 2024-09 | 0 | 3.47 |
| 2024-10 | 0 | 3.81 |
| 2024-11 | 0 | 3.42 |
| 2024-12 | 0 | 3.82 |
| 2025-01 | 0 | 4.09 |
| 2025-02 | 0 | 4.63 |
| 2025-03 | 0 | 5.07 |
| 2025-04 | 0 | 3.32 |
| 2025-05 | 0 | 3.54 |
| 2025-06 | 0 | 3.4 |
| 2025-07 | 0 | 3.22 |
| 2025-08 | 0 | 2.99 |
| 2025-09 | 0 | 2.82 |
| 2025-10 | 0 | 2.96 |
| 2025-11 | 0 | 3.36 |
| 2025-12 | 0 | 4.27 |
| 2026-01 | 0 | 4.02 |
| 2026-02 | 0 | 4 |
| 2026-03 | 0 | 3.78 |
| 2026-04 | 0 | 4 |
| 2026-05 | 0 | 3.12 |
| 2026-06 | 0 | 3.67 |
Regulatory clearances
- K213978 SESE 2022-10-18 (k number procode)
Predicate lineage
K213978 — cites (transitively): K122861 (d1), K123359 (d1), K191579 (d1), K972768 (d2), K070716 (d2), K072879 (d2), K093792 (d2), K102733 (d2), K961074 (d2), K181885 (d2), K043395 (d3), K072073 (d3), K081051 (d3), K002931 (d3), K143705 (d3) — cited as predicate by K223108
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Medos International Sàrl
Nothing in the loaded window.