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Scanlan® VASCU-STATT® single-use bulldog clamp

Model 1001-501 · SCANLAN INTERNATIONAL INC · DI 00846159000016

GDJ — Clamp, Surgical, General & Plastic Surgery · 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 (1)

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.

Malfunction: 1

23562019-02: 0 reports for this device; peer average 2/device2019-04: 0 reports for this device; peer average 1/device2019-06: 0 reports for this device; peer average 1/device2019-08: 1 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 1.5/device2020-03: 0 reports for this device; peer average 1/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/device2020-10: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 1.5/device2021-03: 0 reports for this device; peer average 1/device2021-04: 0 reports for this device; peer average 2/device2021-05: 0 reports for this device; peer average 1.5/device2021-07: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 2/device2021-11: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 2/device2022-03: 0 reports for this device; peer average 1.5/device2022-04: 0 reports for this device; peer average 1.5/device2022-06: 0 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 2/device2022-08: 0 reports for this device; peer average 2/device2022-10: 0 reports for this device; peer average 2/device2022-11: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 3/device2023-01: 0 reports for this device; peer average 3/device2023-02: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 3/device2023-04: 0 reports for this device; peer average 1.5/device2023-05: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 1/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/device2024-02: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1.5/device2024-05: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 1/device2024-09: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 6/device2024-11: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 4/device2025-02: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 4/device2025-06: 0 reports for this device; peer average 2.33/device2025-07: 0 reports for this device; peer average 1.5/device2025-09: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 2.5/device2026-03: 0 reports for this device; peer average 1.5/device2026-04: 0 reports for this device; peer average 2/device2026-06: 0 reports for this device; peer average 2/device02040608091103050607101202030405070809111203040607081011120102030405070809101112010203050708091011010203040607091011120102030406
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0202
2019-0401
2019-0601
2019-0811
2019-0901
2019-1101.5
2020-0301
2020-0501
2020-0601
2020-0701
2020-1001
2020-1201
2021-0201.5
2021-0301
2021-0402
2021-0501.5
2021-0701
2021-0801
2021-0902
2021-1101
2021-1202
2022-0301.5
2022-0401.5
2022-0601
2022-0702
2022-0802
2022-1002
2022-1101
2022-1203
2023-0103
2023-0202
2023-0303
2023-0401.5
2023-0501
2023-0701
2023-0801
2023-0902
2023-1001
2023-1101
2023-1202.5
2024-0101
2024-0201
2024-0301.5
2024-0501
2024-0701
2024-0801
2024-0901
2024-1006
2024-1101
2025-0104
2025-0201
2025-0302
2025-0404
2025-0602.33
2025-0701.5
2025-0902
2025-1002
2025-1101
2025-1202
2026-0101
2026-0202.5
2026-0301.5
2026-0402
2026-0602
This device (reports/month)Average device in GDJ (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