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CODMAN

Model 20-1034 · Cerenovus, Inc. · DI 20886704001130

HBO — Clip, Scalp · Class II · 21 CFR 882.4150

UDILibrary device dossier · generated 2026-09-12 · 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.

61117222019-01: 0 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 22/device2021-04: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 5/device2024-02: 0 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 2/device011004070903090712020205
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-10022
2021-0402
2021-0701
2021-0901
2022-0301
2022-0901
2023-0701
2023-1205
2024-0202
2025-0201
2025-0502
This device (reports/month)Average device in HBO (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Cerenovus, Inc.

  • NAI 2025-05-02 Cerenovus · 0 citations
  • VAI 2016-09-30 Cerenovus Inc · 1 citations
  • VAI 2016-09-21 Cerenovus, Inc. · 1 citations
  • VAI 2016-09-21 Cerenovus, Inc. · 1 citations
  • NAI 2015-10-22 Cerenovus Inc · 0 citations
  • NAI 2015-10-22 Cerenovus Inc · 0 citations
  • VAI 2014-03-14 Cerenovus Inc · 4 citations
  • VAI 2013-11-05 Cerenovus, Inc. · 6 citations
  • VAI 2013-11-05 Cerenovus, Inc. · 6 citations
  • NAI 2011-09-27 Cerenovus, Inc. · 0 citations
  • NAI 2011-09-27 Cerenovus, Inc. · 0 citations
  • VAI 2011-03-04 Cerenovus, Inc. · 1 citations
  • VAI 2011-03-04 Cerenovus, Inc. · 1 citations
  • VAI 2010-12-30 Cerenovus Inc · 7 citations
  • NAI 2010-06-17 Cerenovus, Inc. · 0 citations
  • NAI 2010-06-17 Cerenovus, Inc. · 0 citations