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Dissector

Model MID1 · ATRICURE, INC. · DI 00818354010367

FTDLamp, Surgical · Class II · 21 CFR 878.4580

GDIDissector, Surgical, General & Plastic Surgery · Class I · 21 CFR 878.4800

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 (42)

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.

Injury: 42

24792019-02: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 1/device2019-08: 2 reports for this device; peer average 1.8/device2019-12: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 5/device2020-06: 2 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 1.5/device2020-08: 6 reports for this device; peer average 6/device2020-09: 0 reports for this device; peer average 1.5/device2020-10: 0 reports for this device; peer average 2.5/device2020-11: 4 reports for this device; peer average 3.4/device2020-12: 0 reports for this device; peer average 1/device2021-01: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 2/device2021-03: 0 reports for this device; peer average 1.33/device2021-04: 2 reports for this device; peer average 2/device2021-05: 0 reports for this device; peer average 2/device2021-06: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 1/device2021-10: 0 reports for this device; peer average 3/device2021-11: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 1/device2022-01: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1/device2022-04: 0 reports for this device; peer average 1/device2022-05: 6 reports for this device; peer average 5/device2022-06: 0 reports for this device; peer average 2.2/device2022-07: 0 reports for this device; peer average 4/device2022-08: 0 reports for this device; peer average 3/device2022-09: 2 reports for this device; peer average 1.8/device2022-10: 0 reports for this device; peer average 2.29/device2022-11: 0 reports for this device; peer average 2/device2022-12: 0 reports for this device; peer average 1.17/device2023-01: 0 reports for this device; peer average 1.5/device2023-02: 0 reports for this device; peer average 3.33/device2023-03: 0 reports for this device; peer average 1.83/device2023-04: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 1.33/device2023-06: 0 reports for this device; peer average 1.88/device2023-07: 2 reports for this device; peer average 2.19/device2023-08: 0 reports for this device; peer average 1.67/device2023-09: 2 reports for this device; peer average 6.43/device2023-10: 0 reports for this device; peer average 1.86/device2023-11: 2 reports for this device; peer average 1.68/device2023-12: 0 reports for this device; peer average 1.67/device2024-01: 2 reports for this device; peer average 1.64/device2024-02: 0 reports for this device; peer average 1.71/device2024-03: 2 reports for this device; peer average 1.83/device2024-04: 0 reports for this device; peer average 2.67/device2024-05: 0 reports for this device; peer average 2.5/device2024-06: 4 reports for this device; peer average 2.55/device2024-07: 0 reports for this device; peer average 2.57/device2024-08: 0 reports for this device; peer average 8.67/device2024-09: 0 reports for this device; peer average 2/device2024-10: 0 reports for this device; peer average 2.1/device2024-11: 0 reports for this device; peer average 1.44/device2024-12: 0 reports for this device; peer average 1.63/device2025-01: 0 reports for this device; peer average 3.55/device2025-02: 2 reports for this device; peer average 1.86/device2025-03: 0 reports for this device; peer average 1.82/device2025-04: 0 reports for this device; peer average 1.67/device2025-05: 0 reports for this device; peer average 1.63/device2025-06: 0 reports for this device; peer average 2.44/device2025-07: 0 reports for this device; peer average 1.86/device2025-08: 0 reports for this device; peer average 1.4/device2025-09: 2 reports for this device; peer average 2.86/device2025-10: 0 reports for this device; peer average 1.8/device2025-11: 0 reports for this device; peer average 2.25/device2025-12: 0 reports for this device; peer average 2.5/device2026-01: 0 reports for this device; peer average 2/device2026-02: 0 reports for this device; peer average 1.33/device2026-03: 0 reports for this device; peer average 3.67/device2026-04: 0 reports for this device; peer average 3.33/device2026-05: 0 reports for this device; peer average 2/device2026-06: 0 reports for this device; peer average 2/device0205081202060708091011120102030405060809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0201
2019-0501
2019-0821.8
2019-1201
2020-0205
2020-0622
2020-0701.5
2020-0866
2020-0901.5
2020-1002.5
2020-1143.4
2020-1201
2021-0101
2021-0202
2021-0301.33
2021-0422
2021-0502
2021-0602
2021-0801
2021-0901
2021-1003
2021-1101
2021-1201
2022-0101
2022-0201
2022-0301
2022-0401
2022-0565
2022-0602.2
2022-0704
2022-0803
2022-0921.8
2022-1002.29
2022-1102
2022-1201.17
2023-0101.5
2023-0203.33
2023-0301.83
2023-0401
2023-0501.33
2023-0601.88
2023-0722.19
2023-0801.67
2023-0926.43
2023-1001.86
2023-1121.68
2023-1201.67
2024-0121.64
2024-0201.71
2024-0321.83
2024-0402.67
2024-0502.5
2024-0642.55
2024-0702.57
2024-0808.67
2024-0902
2024-1002.1
2024-1101.44
2024-1201.63
2025-0103.55
2025-0221.86
2025-0301.82
2025-0401.67
2025-0501.63
2025-0602.44
2025-0701.86
2025-0801.4
2025-0922.86
2025-1001.8
2025-1102.25
2025-1202.5
2026-0102
2026-0201.33
2026-0303.67
2026-0403.33
2026-0502
2026-0602
This device (reports/month)Average device in FTD, GDI (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — ATRICURE, INC.

  • NAI 2018-12-13 AtriCure, Inc. · 0 citations
  • NAI 2018-12-13 AtriCure, Inc. · 0 citations
  • VAI 2018-03-09 AtriCure, Inc. · 0 citations
  • VAI 2018-03-09 AtriCure, Inc. · 3 citations
  • VAI 2018-03-09 AtriCure, Inc. · 3 citations
  • VAI 2018-03-09 AtriCure, Inc. · 0 citations
  • NAI 2016-10-13 AtriCure, Inc. · 0 citations
  • NAI 2016-10-13 AtriCure, Inc. · 0 citations
  • VAI 2016-08-29 AtriCure, Inc. · 3 citations
  • VAI 2016-08-29 AtriCure, Inc. · 3 citations
  • NAI 2013-02-26 AtriCure, Inc. · 0 citations
  • NAI 2013-02-26 AtriCure, Inc. · 0 citations
  • VAI 2013-01-18 AtriCure, Inc. · 1 citations
  • VAI 2013-01-18 AtriCure, Inc. · 1 citations
  • NAI 2011-04-01 AtriCure, Inc. · 0 citations
  • NAI 2011-04-01 AtriCure, Inc. · 0 citations
  • VAI 2011-02-22 AtriCure, Inc. · 0 citations
  • VAI 2011-02-22 AtriCure, Inc. · 0 citations
  • NAI 2010-06-21 AtriCure, Inc. · 0 citations
  • NAI 2010-06-21 AtriCure, Inc. · 0 citations