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"Bard® ""C"" Clamp"

Model 0458 · C. R. Bard, Inc. · DI 10801741052504

KNY — Accessories, Catheter, G-U · 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.

23562019-07: 0 reports for this device; peer average 2/device2019-12: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 1/device2021-01: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 1/device2021-04: 0 reports for this device; peer average 2/device2021-05: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 1.5/device2021-09: 0 reports for this device; peer average 4/device2021-11: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 1/device2022-01: 0 reports for this device; peer average 2/device2022-04: 0 reports for this device; peer average 2/device2022-05: 0 reports for this device; peer average 2/device2022-08: 0 reports for this device; peer average 2/device2022-10: 0 reports for this device; peer average 2/device2022-11: 0 reports for this device; peer average 1.75/device2022-12: 0 reports for this device; peer average 2.29/device2023-03: 0 reports for this device; peer average 4/device2023-04: 0 reports for this device; peer average 2.5/device2023-05: 0 reports for this device; peer average 2/device2023-06: 0 reports for this device; peer average 2/device2023-07: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 6/device2024-03: 0 reports for this device; peer average 2/device2024-08: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 2/device2024-11: 0 reports for this device; peer average 2/device2024-12: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 2/device0712010912010304050608091112010405081011120304050607080308101112011003
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0702
2019-1201
2020-0101
2020-0901
2020-1201
2021-0101
2021-0301
2021-0402
2021-0501
2021-0601
2021-0801.5
2021-0904
2021-1101
2021-1201
2022-0102
2022-0402
2022-0502
2022-0802
2022-1002
2022-1101.75
2022-1202.29
2023-0304
2023-0402.5
2023-0502
2023-0602
2023-0702
2023-0806
2024-0302
2024-0801
2024-1002
2024-1102
2024-1201
2025-0102
2025-1001
2026-0302
This device (reports/month)Average device in KNY (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — C. R. Bard, Inc.

  • Warning Letter 2015-07-13 C.R. Bard Inc.
  • Warning Letter 2015-07-13 C.R. Bard Inc.
  • VAI 2026-06-05 C.R. Bard Inc. · 2 citations
  • VAI 2026-06-05 C.R. Bard Inc. · 2 citations
  • NAI 2026-04-21 Bard Peripheral Vascular Inc · 0 citations
  • NAI 2024-11-12 C.R. Bard Inc · 0 citations
  • NAI 2024-11-12 C.R. Bard Inc · 0 citations
  • NAI 2024-08-23 Dymax Corp · 0 citations
  • NAI 2024-03-08 Bard Peripheral Vascular Inc · 0 citations
  • VAI 2023-08-18 Bard Shannon Limited · 3 citations
  • NAI 2022-12-07 Davol, Inc. · 0 citations
  • NAI 2022-05-24 Davol Inc. · 0 citations
  • NAI 2022-04-11 Bard Access Systems, Inc. · 0 citations
  • NAI 2022-02-25 Venclose, Inc. · 0 citations
  • NAI 2021-10-27 Bard Access Systems, Inc. · 0 citations
  • NAI 2021-08-19 C.R. Bard, Inc. · 0 citations
  • VAI 2021-07-30 Dymax Corp · 1 citations
  • NAI 2020-01-28 C.R. Bard Inc · 0 citations
  • NAI 2020-01-28 C.R. Bard Inc · 0 citations
  • VAI 2019-01-31 Clearstream Technologies Ltd · 4 citations
  • NAI 2019-01-25 Lutonix Inc. · 0 citations
  • VAI 2018-11-21 Bard Shannon Limited · 0 citations