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OPERON

Model OZ 7548875 · STRYKER COMMUNICATIONS INC. · DI 07613327394887

LWG — Surgical Table Cushion · Class I · 21 CFR 878.4950

UDILibrary device dossier · generated 2026-09-06 · 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.

12342019-10: 0 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 1.5/device2025-06: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 2.5/device2025-08: 0 reports for this device; peer average 4/device2025-09: 0 reports for this device; peer average 1/device2025-11: 0 reports for this device; peer average 2/device2025-12: 0 reports for this device; peer average 2.67/device2026-01: 0 reports for this device; peer average 3/device2026-02: 0 reports for this device; peer average 2/device101009050304050607080911120102
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-1002
2021-1001
2022-0901
2024-0501
2025-0302
2025-0401
2025-0501.5
2025-0602
2025-0702.5
2025-0804
2025-0901
2025-1102
2025-1202.67
2026-0103
2026-0202
This device (reports/month)Average device in LWG (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — STRYKER COMMUNICATIONS INC.

  • NAI 2016-03-03 Stryker Communications · 0 citations
  • NAI 2012-11-13 Stryker Communications · 0 citations
  • VAI 2012-03-02 Stryker Communications · 2 citations