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SCANLAN® A/V Punch

Model 1001-606B · SCANLAN INTERNATIONAL INC · DI 00846159025811

KDC — Instrument, Surgical, Disposable · Class I · 21 CFR 878.4800

UDILibrary device dossier · generated 2026-09-11 · 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.

12342020-09: 0 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 2/device2021-01: 0 reports for this device; peer average 1/device2022-01: 0 reports for this device; peer average 1/device2022-04: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 3/device2023-03: 0 reports for this device; peer average 3/device2023-04: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 3/device2024-05: 0 reports for this device; peer average 2/device2024-10: 0 reports for this device; peer average 2/device2024-12: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 3/device2025-09: 0 reports for this device; peer average 4/device2025-12: 0 reports for this device; peer average 2/device2026-02: 0 reports for this device; peer average 2/device2026-03: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 2.33/device2026-05: 0 reports for this device; peer average 2/device0911010104110304091105101206091202030405
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-0901
2020-1102
2021-0101
2022-0101
2022-0401
2022-1103
2023-0303
2023-0401
2023-0901
2023-1103
2024-0502
2024-1002
2024-1202
2025-0603
2025-0904
2025-1202
2026-0202
2026-0301
2026-0402.33
2026-0502
This device (reports/month)Average device in KDC (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