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TELIGEN

Model 286006062S · Medos International Sàrl · DI 10705034604527

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

PDQ — Neurosurgical Nerve Locator · Class II · 21 CFR 874.1820

UDILibrary device dossier · generated 2026-09-12 · 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.

25792019-01: 0 reports for this device; peer average 2.67/device2019-02: 0 reports for this device; peer average 3.61/device2019-03: 0 reports for this device; peer average 3.18/device2019-04: 0 reports for this device; peer average 2.75/device2019-05: 0 reports for this device; peer average 3.1/device2019-06: 0 reports for this device; peer average 2.72/device2019-07: 0 reports for this device; peer average 3.23/device2019-08: 0 reports for this device; peer average 2.93/device2019-09: 0 reports for this device; peer average 2.88/device2019-10: 0 reports for this device; peer average 3.84/device2019-11: 0 reports for this device; peer average 5.47/device2019-12: 0 reports for this device; peer average 3.5/device2020-01: 0 reports for this device; peer average 3.39/device2020-02: 0 reports for this device; peer average 4.56/device2020-03: 0 reports for this device; peer average 4.41/device2020-04: 0 reports for this device; peer average 7.69/device2020-05: 0 reports for this device; peer average 2.19/device2020-06: 0 reports for this device; peer average 3.54/device2020-07: 0 reports for this device; peer average 3.94/device2020-08: 0 reports for this device; peer average 2.61/device2020-09: 0 reports for this device; peer average 3.93/device2020-10: 0 reports for this device; peer average 5.63/device2020-11: 0 reports for this device; peer average 5.77/device2020-12: 0 reports for this device; peer average 4.33/device2021-01: 0 reports for this device; peer average 4.68/device2021-02: 0 reports for this device; peer average 4.08/device2021-03: 0 reports for this device; peer average 3.82/device2021-04: 0 reports for this device; peer average 3.78/device2021-05: 0 reports for this device; peer average 4.1/device2021-06: 0 reports for this device; peer average 3.79/device2021-07: 0 reports for this device; peer average 3.2/device2021-08: 0 reports for this device; peer average 2.86/device2021-09: 0 reports for this device; peer average 2.92/device2021-10: 0 reports for this device; peer average 2.33/device2021-11: 0 reports for this device; peer average 4.2/device2021-12: 0 reports for this device; peer average 2.72/device2022-01: 0 reports for this device; peer average 2.54/device2022-02: 0 reports for this device; peer average 3.14/device2022-03: 0 reports for this device; peer average 3.27/device2022-04: 0 reports for this device; peer average 2.46/device2022-05: 0 reports for this device; peer average 3.86/device2022-06: 0 reports for this device; peer average 4.21/device2022-07: 0 reports for this device; peer average 3.34/device2022-08: 0 reports for this device; peer average 2.83/device2022-09: 0 reports for this device; peer average 2.27/device2022-10: 0 reports for this device; peer average 3.77/device2022-11: 0 reports for this device; peer average 3.45/device2022-12: 0 reports for this device; peer average 4.2/device2023-01: 0 reports for this device; peer average 3.13/device2023-02: 0 reports for this device; peer average 3.44/device2023-03: 0 reports for this device; peer average 3.75/device2023-04: 0 reports for this device; peer average 3.26/device2023-05: 0 reports for this device; peer average 3/device2023-06: 0 reports for this device; peer average 2.6/device2023-07: 0 reports for this device; peer average 2.69/device2023-08: 0 reports for this device; peer average 2.48/device2023-09: 0 reports for this device; peer average 4/device2023-10: 0 reports for this device; peer average 3.22/device2023-11: 0 reports for this device; peer average 9/device2023-12: 0 reports for this device; peer average 3.97/device2024-01: 0 reports for this device; peer average 3.68/device2024-02: 0 reports for this device; peer average 4.12/device2024-03: 0 reports for this device; peer average 4.4/device2024-04: 0 reports for this device; peer average 3.95/device2024-05: 0 reports for this device; peer average 4.89/device2024-06: 0 reports for this device; peer average 4.54/device2024-07: 0 reports for this device; peer average 3.9/device2024-08: 0 reports for this device; peer average 4.59/device2024-09: 0 reports for this device; peer average 4.53/device2024-10: 0 reports for this device; peer average 6.25/device2024-11: 0 reports for this device; peer average 4.74/device2024-12: 0 reports for this device; peer average 4.01/device2025-01: 0 reports for this device; peer average 8.37/device2025-02: 0 reports for this device; peer average 4.23/device2025-03: 0 reports for this device; peer average 3.59/device2025-04: 0 reports for this device; peer average 4.16/device2025-05: 0 reports for this device; peer average 4.52/device2025-06: 0 reports for this device; peer average 4.14/device2025-07: 0 reports for this device; peer average 4.32/device2025-08: 0 reports for this device; peer average 5/device2025-09: 0 reports for this device; peer average 3.85/device2025-10: 0 reports for this device; peer average 3.97/device2025-11: 0 reports for this device; peer average 4.12/device2025-12: 0 reports for this device; peer average 4.58/device2026-01: 0 reports for this device; peer average 4.49/device2026-02: 0 reports for this device; peer average 4.23/device2026-03: 0 reports for this device; peer average 4.02/device2026-04: 0 reports for this device; peer average 3.85/device2026-05: 0 reports for this device; peer average 4.95/device2026-06: 0 reports for this device; peer average 3.99/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.67
2019-0203.61
2019-0303.18
2019-0402.75
2019-0503.1
2019-0602.72
2019-0703.23
2019-0802.93
2019-0902.88
2019-1003.84
2019-1105.47
2019-1203.5
2020-0103.39
2020-0204.56
2020-0304.41
2020-0407.69
2020-0502.19
2020-0603.54
2020-0703.94
2020-0802.61
2020-0903.93
2020-1005.63
2020-1105.77
2020-1204.33
2021-0104.68
2021-0204.08
2021-0303.82
2021-0403.78
2021-0504.1
2021-0603.79
2021-0703.2
2021-0802.86
2021-0902.92
2021-1002.33
2021-1104.2
2021-1202.72
2022-0102.54
2022-0203.14
2022-0303.27
2022-0402.46
2022-0503.86
2022-0604.21
2022-0703.34
2022-0802.83
2022-0902.27
2022-1003.77
2022-1103.45
2022-1204.2
2023-0103.13
2023-0203.44
2023-0303.75
2023-0403.26
2023-0503
2023-0602.6
2023-0702.69
2023-0802.48
2023-0904
2023-1003.22
2023-1109
2023-1203.97
2024-0103.68
2024-0204.12
2024-0304.4
2024-0403.95
2024-0504.89
2024-0604.54
2024-0703.9
2024-0804.59
2024-0904.53
2024-1006.25
2024-1104.74
2024-1204.01
2025-0108.37
2025-0204.23
2025-0303.59
2025-0404.16
2025-0504.52
2025-0604.14
2025-0704.32
2025-0805
2025-0903.85
2025-1003.97
2025-1104.12
2025-1204.58
2026-0104.49
2026-0204.23
2026-0304.02
2026-0403.85
2026-0504.95
2026-0603.99
This device (reports/month)Average device in OLO, PDQ (reports/device/month)

Regulatory clearances

  • K223438 SESE 2023-02-10 (k number procode)

Predicate lineage

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

K223438 — cites (transitively): K173134 (d1), K223108 (d1), K100992 (d2), K112709 (d2), K122211 (d2), K133444 (d2), K212245 (d2), K212756 (d2), K213978 (d2), K031510 (d3), K050438 (d3), K170011 (d3), K183605 (d3), K201661 (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), K191943 (d4), K043395 (d5), K072073 (d5), K081051 (d5), K150216 (d5), K992927 (d5), K002931 (d5), K143705 (d5)

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.