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Unnamed device

Model 0682000852 · STRYKER COMMUNICATIONS INC. · DI 07613327166712

FQO — Table, Operating-Room, Ac-Powered · Class I · 21 CFR 878.4960

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.

61218242020-01: 0 reports for this device; peer average 2/device2020-03: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 4/device2020-10: 0 reports for this device; peer average 4/device2020-11: 0 reports for this device; peer average 16/device2020-12: 0 reports for this device; peer average 8/device2021-01: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 16/device2021-03: 0 reports for this device; peer average 24/device2021-04: 0 reports for this device; peer average 5.33/device2021-06: 0 reports for this device; peer average 4/device2021-07: 0 reports for this device; peer average 4/device2021-08: 0 reports for this device; peer average 1/device2021-10: 0 reports for this device; peer average 1/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 1/device2022-02: 0 reports for this device; peer average 5.67/device2022-03: 0 reports for this device; peer average 1/device2022-04: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 1.33/device2022-06: 0 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 1.33/device2022-08: 0 reports for this device; peer average 1.4/device2022-09: 0 reports for this device; peer average 2.67/device2022-10: 0 reports for this device; peer average 1.17/device2022-11: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1.2/device2023-01: 0 reports for this device; peer average 1.25/device2023-02: 0 reports for this device; peer average 1.14/device2023-03: 0 reports for this device; peer average 1.5/device2023-04: 0 reports for this device; peer average 1.29/device2023-05: 0 reports for this device; peer average 1.13/device2023-06: 0 reports for this device; peer average 1.08/device2023-07: 0 reports for this device; peer average 2.22/device2023-08: 0 reports for this device; peer average 1.75/device2023-09: 0 reports for this device; peer average 3.17/device2023-10: 0 reports for this device; peer average 1.68/device2023-11: 0 reports for this device; peer average 1.64/device2023-12: 0 reports for this device; peer average 2.78/device2024-01: 0 reports for this device; peer average 3.33/device2024-02: 0 reports for this device; peer average 2.33/device2024-03: 0 reports for this device; peer average 1.64/device2024-04: 0 reports for this device; peer average 1.64/device2024-05: 0 reports for this device; peer average 1.57/device2024-06: 0 reports for this device; peer average 1.71/device2024-07: 0 reports for this device; peer average 1.33/device2024-08: 0 reports for this device; peer average 1.89/device2024-09: 0 reports for this device; peer average 1.5/device2024-10: 0 reports for this device; peer average 2.17/device2024-11: 0 reports for this device; peer average 2/device2024-12: 0 reports for this device; peer average 1.67/device2025-01: 0 reports for this device; peer average 1.27/device2025-02: 0 reports for this device; peer average 2.31/device2025-03: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 1.4/device2025-05: 0 reports for this device; peer average 2.85/device2025-06: 0 reports for this device; peer average 2.67/device2025-07: 0 reports for this device; peer average 2/device2025-08: 0 reports for this device; peer average 1.67/device2025-09: 0 reports for this device; peer average 2.4/device2025-10: 0 reports for this device; peer average 1.75/device2025-11: 0 reports for this device; peer average 2.25/device2025-12: 0 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 1.9/device2026-02: 0 reports for this device; peer average 2.11/device2026-03: 0 reports for this device; peer average 22.5/device2026-04: 0 reports for this device; peer average 2/device2026-05: 0 reports for this device; peer average 2.33/device2026-06: 0 reports for this device; peer average 2.11/device01030910111201020304060708101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-0102
2020-0301
2020-0904
2020-1004
2020-11016
2020-1208
2021-0101
2021-02016
2021-03024
2021-0405.33
2021-0604
2021-0704
2021-0801
2021-1001
2021-1101
2021-1201
2022-0101
2022-0205.67
2022-0301
2022-0401
2022-0501.33
2022-0601
2022-0701.33
2022-0801.4
2022-0902.67
2022-1001.17
2022-1101
2022-1201.2
2023-0101.25
2023-0201.14
2023-0301.5
2023-0401.29
2023-0501.13
2023-0601.08
2023-0702.22
2023-0801.75
2023-0903.17
2023-1001.68
2023-1101.64
2023-1202.78
2024-0103.33
2024-0202.33
2024-0301.64
2024-0401.64
2024-0501.57
2024-0601.71
2024-0701.33
2024-0801.89
2024-0901.5
2024-1002.17
2024-1102
2024-1201.67
2025-0101.27
2025-0202.31
2025-0302
2025-0401.4
2025-0502.85
2025-0602.67
2025-0702
2025-0801.67
2025-0902.4
2025-1001.75
2025-1102.25
2025-1202
2026-0101.9
2026-0202.11
2026-03022.5
2026-0402
2026-0502.33
2026-0602.11
This device (reports/month)Average device in FQO (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