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AESCULAP

Model BA823SU · Aesculap AG · DI 04046963840853

GDX — Scalpel, One-Piece · 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 (41)

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: 41

71320262019-02: 0 reports for this device; peer average 2/device2019-04: 0 reports for this device; peer average 2/device2019-08: 0 reports for this device; peer average 2/device2020-05: 0 reports for this device; peer average 2/device2020-07: 4 reports for this device; peer average 4/device2020-12: 4 reports for this device; peer average 3/device2021-01: 0 reports for this device; peer average 1.5/device2021-02: 2 reports for this device; peer average 2/device2021-03: 26 reports for this device; peer average 14/device2021-04: 3 reports for this device; peer average 3/device2021-09: 2 reports for this device; peer average 1.67/device2021-11: 0 reports for this device; peer average 3/device2022-04: 0 reports for this device; peer average 3/device2022-09: 0 reports for this device; peer average 3/device2022-10: 0 reports for this device; peer average 3/device2023-02: 0 reports for this device; peer average 1/device2023-06: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 2/device2024-01: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 1/device2026-05: 0 reports for this device; peer average 1/device02040805071201020304091104091002061101040801031205
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0202
2019-0402
2019-0802
2020-0502
2020-0744
2020-1243
2021-0101.5
2021-0222
2021-032614
2021-0433
2021-0921.67
2021-1103
2022-0403
2022-0903
2022-1003
2023-0201
2023-0601
2023-1102
2024-0101
2024-0401
2024-0801
2025-0101
2025-0301
2025-1201
2026-0501
This device (reports/month)Average device in GDX (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