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TELIGEN

Model 186000002S · Medos International Sàrl · DI 10705034571607

GAD — Retractor · Class I · 21 CFR 878.4800

HRX — Arthroscope · Class II · 21 CFR 888.1100

LXH — Orthopedic Manual Surgical Instrument · Class I · 21 CFR 888.4540

OLO — Orthopedic Stereotaxic Instrument · Class II · 21 CFR 882.4560

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.

13452019-01: 0 reports for this device; peer average 4.62/device2019-02: 0 reports for this device; peer average 2.83/device2019-03: 0 reports for this device; peer average 2.84/device2019-04: 0 reports for this device; peer average 2.67/device2019-05: 0 reports for this device; peer average 2.85/device2019-06: 0 reports for this device; peer average 2.68/device2019-07: 0 reports for this device; peer average 2.78/device2019-08: 0 reports for this device; peer average 2.79/device2019-09: 0 reports for this device; peer average 3/device2019-10: 0 reports for this device; peer average 2.96/device2019-11: 0 reports for this device; peer average 3.43/device2019-12: 0 reports for this device; peer average 3.07/device2020-01: 0 reports for this device; peer average 3.1/device2020-02: 0 reports for this device; peer average 3.5/device2020-03: 0 reports for this device; peer average 3.25/device2020-04: 0 reports for this device; peer average 4.07/device2020-05: 0 reports for this device; peer average 2.61/device2020-06: 0 reports for this device; peer average 3.39/device2020-07: 0 reports for this device; peer average 4.08/device2020-08: 0 reports for this device; peer average 3.56/device2020-09: 0 reports for this device; peer average 4.37/device2020-10: 0 reports for this device; peer average 5.21/device2020-11: 0 reports for this device; peer average 4.41/device2020-12: 0 reports for this device; peer average 4.71/device2021-01: 0 reports for this device; peer average 4.45/device2021-02: 0 reports for this device; peer average 4.16/device2021-03: 0 reports for this device; peer average 4.24/device2021-04: 0 reports for this device; peer average 4.11/device2021-05: 0 reports for this device; peer average 3.76/device2021-06: 0 reports for this device; peer average 3.67/device2021-07: 0 reports for this device; peer average 3.16/device2021-08: 0 reports for this device; peer average 3.53/device2021-09: 0 reports for this device; peer average 2.92/device2021-10: 0 reports for this device; peer average 2.93/device2021-11: 0 reports for this device; peer average 3.4/device2021-12: 0 reports for this device; peer average 3.02/device2022-01: 0 reports for this device; peer average 2.91/device2022-02: 0 reports for this device; peer average 3.22/device2022-03: 0 reports for this device; peer average 3.43/device2022-04: 0 reports for this device; peer average 3.24/device2022-05: 0 reports for this device; peer average 3.79/device2022-06: 0 reports for this device; peer average 3.3/device2022-07: 0 reports for this device; peer average 2.87/device2022-08: 0 reports for this device; peer average 2.93/device2022-09: 0 reports for this device; peer average 2.97/device2022-10: 0 reports for this device; peer average 3.38/device2022-11: 0 reports for this device; peer average 3.79/device2022-12: 0 reports for this device; peer average 4/device2023-01: 0 reports for this device; peer average 4.38/device2023-02: 0 reports for this device; peer average 3.36/device2023-03: 0 reports for this device; peer average 3.98/device2023-04: 0 reports for this device; peer average 3.46/device2023-05: 0 reports for this device; peer average 3.44/device2023-06: 0 reports for this device; peer average 3.33/device2023-07: 0 reports for this device; peer average 3.13/device2023-08: 0 reports for this device; peer average 3.22/device2023-09: 0 reports for this device; peer average 3.16/device2023-10: 0 reports for this device; peer average 2.98/device2023-11: 0 reports for this device; peer average 5.17/device2023-12: 0 reports for this device; peer average 4.53/device2024-01: 0 reports for this device; peer average 3.66/device2024-02: 0 reports for this device; peer average 3.91/device2024-03: 0 reports for this device; peer average 3.5/device2024-04: 0 reports for this device; peer average 4.08/device2024-05: 0 reports for this device; peer average 4.46/device2024-06: 0 reports for this device; peer average 4.6/device2024-07: 0 reports for this device; peer average 3.39/device2024-08: 0 reports for this device; peer average 3.55/device2024-09: 0 reports for this device; peer average 3.68/device2024-10: 0 reports for this device; peer average 4.29/device2024-11: 0 reports for this device; peer average 3.73/device2024-12: 0 reports for this device; peer average 3.84/device2025-01: 0 reports for this device; peer average 5.4/device2025-02: 0 reports for this device; peer average 4.46/device2025-03: 0 reports for this device; peer average 4.54/device2025-04: 0 reports for this device; peer average 3.51/device2025-05: 0 reports for this device; peer average 3.77/device2025-06: 0 reports for this device; peer average 3.6/device2025-07: 0 reports for this device; peer average 3.42/device2025-08: 0 reports for this device; peer average 3.48/device2025-09: 0 reports for this device; peer average 3.08/device2025-10: 0 reports for this device; peer average 3.22/device2025-11: 0 reports for this device; peer average 3.6/device2025-12: 0 reports for this device; peer average 4.33/device2026-01: 0 reports for this device; peer average 4.13/device2026-02: 0 reports for this device; peer average 3.99/device2026-03: 0 reports for this device; peer average 3.84/device2026-04: 0 reports for this device; peer average 3.92/device2026-05: 0 reports for this device; peer average 3.54/device2026-06: 0 reports for this device; peer average 3.74/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104.62
2019-0202.83
2019-0302.84
2019-0402.67
2019-0502.85
2019-0602.68
2019-0702.78
2019-0802.79
2019-0903
2019-1002.96
2019-1103.43
2019-1203.07
2020-0103.1
2020-0203.5
2020-0303.25
2020-0404.07
2020-0502.61
2020-0603.39
2020-0704.08
2020-0803.56
2020-0904.37
2020-1005.21
2020-1104.41
2020-1204.71
2021-0104.45
2021-0204.16
2021-0304.24
2021-0404.11
2021-0503.76
2021-0603.67
2021-0703.16
2021-0803.53
2021-0902.92
2021-1002.93
2021-1103.4
2021-1203.02
2022-0102.91
2022-0203.22
2022-0303.43
2022-0403.24
2022-0503.79
2022-0603.3
2022-0702.87
2022-0802.93
2022-0902.97
2022-1003.38
2022-1103.79
2022-1204
2023-0104.38
2023-0203.36
2023-0303.98
2023-0403.46
2023-0503.44
2023-0603.33
2023-0703.13
2023-0803.22
2023-0903.16
2023-1002.98
2023-1105.17
2023-1204.53
2024-0103.66
2024-0203.91
2024-0303.5
2024-0404.08
2024-0504.46
2024-0604.6
2024-0703.39
2024-0803.55
2024-0903.68
2024-1004.29
2024-1103.73
2024-1203.84
2025-0105.4
2025-0204.46
2025-0304.54
2025-0403.51
2025-0503.77
2025-0603.6
2025-0703.42
2025-0803.48
2025-0903.08
2025-1003.22
2025-1103.6
2025-1204.33
2026-0104.13
2026-0203.99
2026-0303.84
2026-0403.92
2026-0503.54
2026-0603.74
This device (reports/month)Average device in GAD, HRX, LXH, OLO (reports/device/month)

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

K223108 — cites (transitively): K122211 (d1), K133444 (d1), K212245 (d1), K212756 (d1), K213978 (d1), K050438 (d2), K170011 (d2), K183605 (d2), K201661 (d2), K122861 (d2), K123359 (d2), K191579 (d2), K972768 (d3), K070716 (d3), K072879 (d3), K093792 (d3), K102733 (d3), K961074 (d3), K153660 (d3), K083310 (d3), K181885 (d3), K191943 (d3), K043395 (d4), K072073 (d4), K081051 (d4), K150216 (d4), K992927 (d4), K002931 (d4), K143705 (d4) — cited as predicate by K223438, K233254

K233254 — cites (transitively): K212756 (d1), K223108 (d1), K122211 (d2), K201661 (d2), K212245 (d2), K133444 (d2), K213978 (d2), K050438 (d3), K183605 (d3), K191943 (d3), K170011 (d3), K122861 (d3), K123359 (d3), K191579 (d3), K972768 (d4), K070716 (d4), K072879 (d4), K093792 (d4), K102733 (d4), K961074 (d4), K153660 (d4), K083310 (d4), K181885 (d4), K043395 (d5), K072073 (d5), K081051 (d5), K150216 (d5), K992927 (d5), K002931 (d5), K143705 (d5) — cited as predicate by K241893, K260240

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Medos International Sàrl

Nothing in the loaded window.