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Irrigation Set

Model 313002 · B. BRAUN MEDICAL INC. · DI 04046964291449

LJH — System, Irrigation, Urological · Class II · 21 CFR 876.5130

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.

23562019-01: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 1/device2020-04: 0 reports for this device; peer average 1/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 2/device2020-10: 0 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 2/device2020-12: 0 reports for this device; peer average 1/device2021-01: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 1/device2021-07: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 1.5/device2023-03: 0 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 1/device2023-06: 0 reports for this device; peer average 2/device2023-07: 0 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 2.5/device2024-10: 0 reports for this device; peer average 6/device2024-12: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1.5/device2025-03: 0 reports for this device; peer average 1.5/device2025-05: 0 reports for this device; peer average 1/device2025-06: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 1/device2025-11: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 3/device2026-04: 0 reports for this device; peer average 1.5/device01101104080910111201050702091011120203050607081011120206101201030506070810110204
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-1001
2019-1101
2020-0401
2020-0801
2020-0902
2020-1001
2020-1102
2020-1201
2021-0101
2021-0501
2021-0701
2022-0201
2022-0901
2022-1001
2022-1101
2022-1201
2023-0201.5
2023-0302
2023-0501
2023-0602
2023-0701
2023-0801
2023-1001
2023-1101
2023-1201
2024-0201
2024-0602.5
2024-1006
2024-1201
2025-0101.5
2025-0301.5
2025-0501
2025-0602
2025-0701
2025-0801
2025-1001
2025-1101
2026-0203
2026-0401.5
This device (reports/month)Average device in LJH (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — B. BRAUN MEDICAL INC.

  • NAI 2024-09-20 B. BRAUN DOMINICAN REPUBLIC INC. · 0 citations
  • NAI 2023-10-13 B. Braun US Pharmaceutical Manufacturing, LLC · 0 citations
  • NAI 2018-06-01 B. Braun Medical, Inc. · 0 citations
  • NAI 2018-06-01 B. Braun Medical, Inc. · 0 citations
  • NAI 2018-02-22 B. BRAUN DOMINICAN REPUBLIC INC. · 0 citations
  • VAI 2016-08-26 B. Braun Medical, Inc. · 2 citations
  • VAI 2016-08-26 B. Braun Medical, Inc. · 2 citations
  • NAI 2014-06-03 B. BRAUN MEDICAL AG · 0 citations
  • NAI 2013-01-10 B. BRAUN DOMINICAN REPUBLIC INC. · 0 citations
  • VAI 2012-12-13 B. Braun Medical, Inc. · 0 citations
  • VAI 2012-12-13 B. Braun Medical, Inc. · 0 citations
  • OAI 2012-08-16 B Braun Medical, Inc. · 6 citations
  • NAI 2011-03-21 B. Braun US Pharmaceutical Manufacturing, LLC · 0 citations
  • OAI 2010-10-08 B Braun Medical, Inc. · 5 citations