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Welmed

Model 1923-4041LF · WELMED INC. · DI 00849296015080

GBQ — Catheter, Continuous Irrigation · Class I · 21 CFR 878.4200

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.

91827362021-12: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 3/device2023-01: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 6/device2023-06: 0 reports for this device; peer average 36/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 1/device2024-11: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 2/device1208010305060405110307
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-1201
2022-0803
2023-0101
2023-0302
2023-0506
2023-06036
2024-0402
2024-0501
2024-1101
2025-0302
2025-0702
This device (reports/month)Average device in GBQ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — WELMED INC.

  • VAI 2026-02-19 Welmed Inc. · 2 citations
  • VAI 2026-02-19 Welmed Inc. · 2 citations
  • VAI 2022-03-23 Welmed Inc. · 4 citations
  • VAI 2022-03-23 Welmed Inc. · 4 citations
  • NAI 2017-08-30 Welmed Inc. · 0 citations
  • NAI 2017-08-30 Welmed Inc. · 0 citations