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AESCULAP

Model BV656R · Aesculap AG · DI 04038653144228

FFO — Retractor, Self-Retaining · Class I · 21 CFR 876.4730

UDILibrary device dossier · generated 2026-09-14 · 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.

12342020-08: 0 reports for this device; peer average 2/device2020-09: 0 reports for this device; peer average 2/device2022-03: 0 reports for this device; peer average 2/device2024-10: 0 reports for this device; peer average 3.5/device2025-03: 0 reports for this device; peer average 1/device2025-04: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 1/device2025-09: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1/device080903100304070902
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-0802
2020-0902
2022-0302
2024-1003.5
2025-0301
2025-0401
2025-0701
2025-0901
2026-0201
This device (reports/month)Average device in FFO (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