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SCANLAN® Retractor

Model 8008-41 · SCANLAN INTERNATIONAL INC · DI 00846159023534

GAD — Retractor · Class I · 21 CFR 878.4800

UDILibrary device dossier · generated 2026-09-06 · 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.

12342019-01: 0 reports for this device; peer average 1/device2019-02: 0 reports for this device; peer average 1.33/device2019-03: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 1.5/device2019-05: 0 reports for this device; peer average 1.5/device2019-06: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 1/device2019-08: 0 reports for this device; peer average 1.33/device2019-09: 0 reports for this device; peer average 1.38/device2019-10: 0 reports for this device; peer average 1.4/device2019-11: 0 reports for this device; peer average 1.33/device2019-12: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 2/device2020-03: 0 reports for this device; peer average 1.25/device2020-04: 0 reports for this device; peer average 2/device2020-05: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 1.75/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 1.17/device2020-10: 0 reports for this device; peer average 1.5/device2020-11: 0 reports for this device; peer average 1.1/device2020-12: 0 reports for this device; peer average 2.44/device2021-01: 0 reports for this device; peer average 1.5/device2021-02: 0 reports for this device; peer average 2.4/device2021-03: 0 reports for this device; peer average 1.43/device2021-04: 0 reports for this device; peer average 1.5/device2021-05: 0 reports for this device; peer average 1.33/device2021-06: 0 reports for this device; peer average 1.75/device2021-07: 0 reports for this device; peer average 1.5/device2021-08: 0 reports for this device; peer average 2.33/device2021-09: 0 reports for this device; peer average 1/device2021-10: 0 reports for this device; peer average 2.2/device2021-11: 0 reports for this device; peer average 1.25/device2021-12: 0 reports for this device; peer average 1.09/device2022-01: 0 reports for this device; peer average 2.55/device2022-02: 0 reports for this device; peer average 1.5/device2022-03: 0 reports for this device; peer average 2/device2022-04: 0 reports for this device; peer average 1.71/device2022-05: 0 reports for this device; peer average 1.6/device2022-06: 0 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 1.5/device2022-09: 0 reports for this device; peer average 1.75/device2022-10: 0 reports for this device; peer average 2.5/device2022-11: 0 reports for this device; peer average 1.75/device2022-12: 0 reports for this device; peer average 2.25/device2023-01: 0 reports for this device; peer average 1.75/device2023-02: 0 reports for this device; peer average 1.33/device2023-03: 0 reports for this device; peer average 4/device2023-04: 0 reports for this device; peer average 1.67/device2023-05: 0 reports for this device; peer average 1.4/device2023-06: 0 reports for this device; peer average 1.33/device2023-07: 0 reports for this device; peer average 1.5/device2023-08: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 1.83/device2023-11: 0 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 2.5/device2024-01: 0 reports for this device; peer average 1.4/device2024-02: 0 reports for this device; peer average 3.57/device2024-03: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 1.57/device2024-05: 0 reports for this device; peer average 1.83/device2024-06: 0 reports for this device; peer average 2/device2024-07: 0 reports for this device; peer average 1.25/device2024-08: 0 reports for this device; peer average 2/device2024-09: 0 reports for this device; peer average 1.5/device2024-10: 0 reports for this device; peer average 1.6/device2024-11: 0 reports for this device; peer average 1/device2024-12: 0 reports for this device; peer average 2/device2025-01: 0 reports for this device; peer average 1.33/device2025-02: 0 reports for this device; peer average 1.67/device2025-03: 0 reports for this device; peer average 1.38/device2025-04: 0 reports for this device; peer average 2/device2025-05: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 1.67/device2025-07: 0 reports for this device; peer average 1.29/device2025-08: 0 reports for this device; peer average 1/device2025-09: 0 reports for this device; peer average 1.83/device2025-10: 0 reports for this device; peer average 1.67/device2025-11: 0 reports for this device; peer average 4.17/device2025-12: 0 reports for this device; peer average 1.75/device2026-01: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1.6/device2026-03: 0 reports for this device; peer average 1.33/device2026-04: 0 reports for this device; peer average 1.78/device2026-05: 0 reports for this device; peer average 1/device2026-06: 0 reports for this device; peer average 2.2/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0201.33
2019-0301
2019-0401.5
2019-0501.5
2019-0601
2019-0701
2019-0801.33
2019-0901.38
2019-1001.4
2019-1101.33
2019-1201
2020-0101
2020-0202
2020-0301.25
2020-0402
2020-0501
2020-0601
2020-0701.75
2020-0801
2020-0901.17
2020-1001.5
2020-1101.1
2020-1202.44
2021-0101.5
2021-0202.4
2021-0301.43
2021-0401.5
2021-0501.33
2021-0601.75
2021-0701.5
2021-0802.33
2021-0901
2021-1002.2
2021-1101.25
2021-1201.09
2022-0102.55
2022-0201.5
2022-0302
2022-0401.71
2022-0501.6
2022-0601
2022-0701
2022-0801.5
2022-0901.75
2022-1002.5
2022-1101.75
2022-1202.25
2023-0101.75
2023-0201.33
2023-0304
2023-0401.67
2023-0501.4
2023-0601.33
2023-0701.5
2023-0801
2023-0901
2023-1001.83
2023-1101
2023-1202.5
2024-0101.4
2024-0203.57
2024-0301
2024-0401.57
2024-0501.83
2024-0602
2024-0701.25
2024-0802
2024-0901.5
2024-1001.6
2024-1101
2024-1202
2025-0101.33
2025-0201.67
2025-0301.38
2025-0402
2025-0502
2025-0601.67
2025-0701.29
2025-0801
2025-0901.83
2025-1001.67
2025-1104.17
2025-1201.75
2026-0101
2026-0201.6
2026-0301.33
2026-0401.78
2026-0501
2026-0602.2
This device (reports/month)Average device in GAD (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — SCANLAN INTERNATIONAL INC

  • NAI 2019-08-15 Scanlan International, Inc. · 0 citations
  • NAI 2019-08-15 Scanlan International, Inc. · 0 citations
  • NAI 2016-02-03 Scanlan International, Inc. · 0 citations
  • NAI 2016-02-03 Scanlan International, Inc. · 0 citations
  • NAI 2012-10-17 Scanlan International, Inc. · 0 citations
  • NAI 2012-10-17 Scanlan International, Inc. · 0 citations
  • NAI 2010-06-22 Scanlan International, Inc. · 0 citations
  • NAI 2010-06-22 Scanlan International, Inc. · 0 citations