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"628 - Non-Stick Pads 2""x 3"" - 4/unit"

Model R523-574 · Certified Safety Manufacturing, Inc. · DI 00766588235745

EFQ — Gauze/Sponge, Internal

UDILibrary device dossier · generated 2026-09-07 · 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.

12342019-12: 0 reports for this device; peer average 2/device2020-05: 0 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 2.5/device2022-04: 0 reports for this device; peer average 3/device2022-06: 0 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 2/device2023-09: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 2/device2023-11: 0 reports for this device; peer average 1/device2024-07: 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 1.5/device2024-12: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 2.67/device2025-04: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 3.33/device2025-06: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 4/device2025-09: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 1.5/device2025-11: 0 reports for this device; peer average 1.5/device2025-12: 0 reports for this device; peer average 1/device2026-01: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 2/device2026-03: 0 reports for this device; peer average 2/device2026-06: 0 reports for this device; peer average 1.33/device1205110308030406070910110708101201020304050607080910111201020306
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-1202
2020-0501
2020-1101
2021-0301
2021-0801
2022-0302.5
2022-0403
2022-0601
2022-0702
2023-0901
2023-1002
2023-1101
2024-0702
2024-0801
2024-1001.5
2024-1201
2025-0102
2025-0201
2025-0302.67
2025-0401
2025-0503.33
2025-0601
2025-0701
2025-0804
2025-0901
2025-1001.5
2025-1101.5
2025-1201
2026-0101
2026-0202
2026-0302
2026-0601.33
This device (reports/month)Average device in EFQ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Certified Safety Manufacturing, Inc.

  • VAI 2025-05-15 Certified Safety Manufacturing, Inc. · 1 citations
  • VAI 2019-10-15 Certified Safety Manufacturing, Inc. · 7 citations
  • VAI 2013-08-29 Certified Safety Manufacturing, Inc. · 3 citations
  • NAI 2010-01-13 Certified Safety Manufacturing, Inc. · 0 citations