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Unnamed device

Model 825638 · Richard Wolf GmbH · DI 04055207009482

EOX — Esophagoscope (Flexible Or Rigid) · Class II · 21 CFR 874.4710

UDILibrary device dossier · generated 2026-09-07 · 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.

24572020-10: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 3/device2023-04: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 1/device2023-06: 0 reports for this device; peer average 7/device101201040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-1001
2022-1201
2023-0103
2023-0401
2023-0501
2023-0607
This device (reports/month)Average device in EOX (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Richard Wolf GmbH

  • Warning Letter 2014-02-28 Richard Wolf Medical Instruments Corp.
  • NAI 2025-01-13 Richard Wolf Medical Instruments Corp. · 0 citations
  • NAI 2023-04-19 Richard Wolf Medical Instruments Corp. · 0 citations
  • OAI 2022-10-20 Richard Wolf GmbH · 0 citations
  • OAI 2022-10-20 Richard Wolf GmbH · 0 citations
  • VAI 2020-03-18 Richard Wolf Medical Instruments Corp. · 1 citations
  • VAI 2019-09-10 Richard Wolf GmbH · 0 citations
  • VAI 2019-09-10 Richard Wolf GmbH · 0 citations
  • VAI 2018-07-17 Richard Wolf Medical Instruments Corp. · 6 citations
  • VAI 2014-10-10 Richard Wolf Medical Instruments Corp. · 8 citations
  • NAI 2014-08-29 Richard Wolf GmbH · 0 citations
  • NAI 2014-08-29 Richard Wolf GmbH · 0 citations
  • OAI 2013-05-08 Richard Wolf Medical Instruments Corp. · 5 citations
  • VAI 2012-09-10 Richard Wolf Medical Instruments Corp. · 1 citations
  • VAI 2010-06-10 Richard Wolf GmbH · 1 citations
  • VAI 2010-06-10 Richard Wolf GmbH · 1 citations
  • NAI 2010-03-03 Richard Wolf Medical Instruments Corp. · 0 citations