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Centurion

Model PE3620 · CENTURION MEDICAL PRODUCTS CORPORATION · DI 10653160328636

KNA — Instrument, Manual, Specialized Obstetric-Gynecologic · Class II · 21 CFR 884.4530

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.

23562019-01: 0 reports for this device; peer average 2.5/device2019-07: 0 reports for this device; peer average 3/device2020-02: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 3/device2021-12: 0 reports for this device; peer average 3/device2022-03: 0 reports for this device; peer average 1/device2022-04: 0 reports for this device; peer average 2/device2022-11: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 6/device2025-01: 0 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 3/device2025-05: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 2/device010702091203041103080102040503
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.5
2019-0703
2020-0202
2021-0903
2021-1203
2022-0301
2022-0402
2022-1102
2023-0301
2023-0806
2025-0102
2025-0202
2025-0403
2025-0501
2026-0302
This device (reports/month)Average device in KNA (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — CENTURION MEDICAL PRODUCTS CORPORATION

  • Warning Letter 2020-06-11 Centurion Medical Products, LP
  • NAI 2023-02-10 Centurion Medical Products, LP · 0 citations
  • NAI 2022-04-05 Centurion Medical Products, LP · 0 citations
  • OAI 2019-11-01 Centurion Medical Products, LP · 5 citations
  • OAI 2019-08-20 Centurion Medical Products, LP · 5 citations
  • NAI 2018-08-17 Centurion Medical Products LP · 0 citations
  • NAI 2018-06-26 Centurion Medical Products, LP · 0 citations
  • NAI 2018-01-31 Centurion Medical Products, LP · 0 citations
  • VAI 2016-09-28 Centurion Medical Products, LP · 8 citations
  • VAI 2015-09-21 Centurion Medical Products, LP · 1 citations
  • VAI 2015-03-31 Centurion Medical Products LP · 4 citations
  • OAI 2015-03-26 Centurion Medical Products, LP · 0 citations
  • VAI 2013-11-18 Centurion Medical Products, LP · 0 citations
  • VAI 2013-03-19 Centurion Medical Products, LP · 5 citations
  • VAI 2012-06-29 Centurion Medical Products, LP · 0 citations
  • NAI 2011-06-02 Centurion Medical Products, LP · 0 citations
  • VAI 2010-06-28 Centurion Medical Products LP · 8 citations
  • NAI 2010-03-08 Centurion Medical Products, LP · 0 citations