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AESCULAP

Model FB911R · Aesculap AG · DI 04038653158447

FZT — Cutter, Surgical · 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.

4811152019-01: 0 reports for this device; peer average 3/device2019-03: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 2/device2019-05: 0 reports for this device; peer average 2/device2019-06: 0 reports for this device; peer average 2/device2019-07: 0 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 9/device2019-11: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 1.5/device2020-02: 0 reports for this device; peer average 2/device2020-03: 0 reports for this device; peer average 3/device2020-05: 0 reports for this device; peer average 4/device2020-06: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 4/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 2.67/device2020-11: 0 reports for this device; peer average 3/device2020-12: 0 reports for this device; peer average 7/device2021-01: 0 reports for this device; peer average 3/device2021-02: 0 reports for this device; peer average 2/device2021-03: 0 reports for this device; peer average 4.5/device2021-04: 0 reports for this device; peer average 3.75/device2021-05: 0 reports for this device; peer average 4/device2021-06: 0 reports for this device; peer average 4/device2021-07: 0 reports for this device; peer average 5/device2021-08: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 2.5/device2021-11: 0 reports for this device; peer average 2/device2021-12: 0 reports for this device; peer average 1/device2022-01: 0 reports for this device; peer average 2/device2022-02: 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 3.5/device2022-05: 0 reports for this device; peer average 4/device2022-06: 0 reports for this device; peer average 6/device2022-07: 0 reports for this device; peer average 2.67/device2022-08: 0 reports for this device; peer average 5.5/device2022-09: 0 reports for this device; peer average 2.33/device2022-10: 0 reports for this device; peer average 6/device2022-11: 0 reports for this device; peer average 7/device2022-12: 0 reports for this device; peer average 6/device2023-01: 0 reports for this device; peer average 5/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 4/device2023-05: 0 reports for this device; peer average 8/device2023-06: 0 reports for this device; peer average 5/device2023-07: 0 reports for this device; peer average 4/device2023-08: 0 reports for this device; peer average 3/device2023-09: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 4/device2023-11: 0 reports for this device; peer average 3/device2023-12: 0 reports for this device; peer average 2/device2024-01: 0 reports for this device; peer average 2/device2024-02: 0 reports for this device; peer average 3/device2024-03: 0 reports for this device; peer average 4/device2024-04: 0 reports for this device; peer average 4/device2024-05: 0 reports for this device; peer average 2/device2024-06: 0 reports for this device; peer average 15/device2024-07: 0 reports for this device; peer average 14/device2024-08: 0 reports for this device; peer average 5.5/device2024-09: 0 reports for this device; peer average 5/device2024-10: 0 reports for this device; peer average 6/device2024-11: 0 reports for this device; peer average 3/device2024-12: 0 reports for this device; peer average 2/device2025-01: 0 reports for this device; peer average 6/device2025-02: 0 reports for this device; peer average 1.5/device2025-03: 0 reports for this device; peer average 7/device2025-04: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 8/device2025-07: 0 reports for this device; peer average 10/device2025-08: 0 reports for this device; peer average 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 2/device2025-12: 0 reports for this device; peer average 3/device2026-02: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 3/device2026-04: 0 reports for this device; peer average 1.5/device2026-05: 0 reports for this device; peer average 1/device2026-06: 0 reports for this device; peer average 2/device01030405060709101112010203050607080910111201020304050607080910111201020304050607080910111201020304050607080910111201020304050607080910111201020304060708091011120203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103
2019-0301
2019-0402
2019-0502
2019-0602
2019-0701
2019-0902
2019-1009
2019-1101
2019-1201
2020-0101.5
2020-0202
2020-0303
2020-0504
2020-0601
2020-0704
2020-0801
2020-0901
2020-1002.67
2020-1103
2020-1207
2021-0103
2021-0202
2021-0304.5
2021-0403.75
2021-0504
2021-0604
2021-0705
2021-0802
2021-0902
2021-1002.5
2021-1102
2021-1201
2022-0102
2022-0202
2022-0301.5
2022-0403.5
2022-0504
2022-0606
2022-0702.67
2022-0805.5
2022-0902.33
2022-1006
2022-1107
2022-1206
2023-0105
2023-0202
2023-0303
2023-0404
2023-0508
2023-0605
2023-0704
2023-0803
2023-0901
2023-1004
2023-1103
2023-1202
2024-0102
2024-0203
2024-0304
2024-0404
2024-0502
2024-06015
2024-07014
2024-0805.5
2024-0905
2024-1006
2024-1103
2024-1202
2025-0106
2025-0201.5
2025-0307
2025-0402
2025-0608
2025-07010
2025-0805
2025-0902
2025-1002
2025-1102
2025-1203
2026-0201
2026-0303
2026-0401.5
2026-0501
2026-0602
This device (reports/month)Average device in FZT (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Aesculap AG

  • Warning Letter 2011-09-26 Aesculap AG
  • Warning Letter 2011-09-26 Aesculap AG
  • NAI 2025-07-11 Aesculap Inc · 0 citations
  • NAI 2025-07-11 Aesculap Inc · 0 citations
  • NAI 2022-07-21 Aesculap AG · 0 citations
  • NAI 2022-07-21 Aesculap AG · 0 citations
  • VAI 2021-08-11 Aesculap Inc · 3 citations
  • VAI 2021-08-11 Aesculap Inc · 3 citations
  • VAI 2018-06-13 Aesculap Inc · 0 citations
  • VAI 2018-06-13 Aesculap Inc · 0 citations
  • NAI 2016-09-22 Aesculap AG · 0 citations
  • NAI 2016-09-22 Aesculap AG · 0 citations
  • VAI 2016-09-14 Aesculap Inc · 0 citations
  • VAI 2016-09-14 Aesculap Inc · 0 citations
  • NAI 2016-07-13 Aesculap Inc · 0 citations
  • NAI 2016-07-13 Aesculap Inc · 0 citations
  • NAI 2015-07-16 Aesculap AG · 1 citations
  • NAI 2015-07-16 Aesculap AG · 1 citations
  • NAI 2015-05-05 Aesculap Inc · 0 citations
  • NAI 2015-05-05 Aesculap Inc · 0 citations
  • NAI 2014-10-23 Aesculap Inc · 0 citations
  • NAI 2014-10-23 Aesculap Inc · 0 citations