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DTE

Model D6 · Guilin Woodpecker Medical Instrument Co., Ltd. · DI 06944843601502

ELC — Scaler, Ultrasonic · Class II · 21 CFR 872.4850

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.

13452019-01: 0 reports for this device; peer average 3/device2019-02: 0 reports for this device; peer average 3/device2019-03: 0 reports for this device; peer average 2/device2019-04: 0 reports for this device; peer average 1.4/device2019-05: 0 reports for this device; peer average 1.56/device2019-06: 0 reports for this device; peer average 3/device2019-07: 0 reports for this device; peer average 1.67/device2019-08: 0 reports for this device; peer average 2.6/device2019-09: 0 reports for this device; peer average 1.4/device2019-10: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 1.67/device2020-01: 0 reports for this device; peer average 1.5/device2020-02: 0 reports for this device; peer average 1.67/device2020-03: 0 reports for this device; peer average 2.67/device2020-04: 0 reports for this device; peer average 1.6/device2020-06: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 1.5/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 1.67/device2020-11: 0 reports for this device; peer average 1.75/device2021-01: 0 reports for this device; peer average 1.33/device2021-02: 0 reports for this device; peer average 1.67/device2021-03: 0 reports for this device; peer average 2/device2021-04: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 1/device2021-07: 0 reports for this device; peer average 3/device2021-08: 0 reports for this device; peer average 5/device2021-09: 0 reports for this device; peer average 1/device2021-10: 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 1.17/device2022-02: 0 reports for this device; peer average 3/device2022-03: 0 reports for this device; peer average 2/device2022-04: 0 reports for this device; peer average 3/device2022-05: 0 reports for this device; peer average 2.2/device2022-07: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 2.8/device2022-10: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 1.2/device2023-04: 0 reports for this device; peer average 1.67/device2023-05: 0 reports for this device; peer average 1.43/device2023-06: 0 reports for this device; peer average 1.67/device2023-07: 0 reports for this device; peer average 1.6/device2023-08: 0 reports for this device; peer average 1.14/device2023-09: 0 reports for this device; peer average 1.83/device2023-10: 0 reports for this device; peer average 1.75/device2023-11: 0 reports for this device; peer average 1.5/device2023-12: 0 reports for this device; peer average 1.5/device2024-01: 0 reports for this device; peer average 1.75/device2024-02: 0 reports for this device; peer average 1.33/device2024-03: 0 reports for this device; peer average 1.5/device2024-04: 0 reports for this device; peer average 1.36/device2024-05: 0 reports for this device; peer average 2.31/device2024-06: 0 reports for this device; peer average 1.64/device2024-07: 0 reports for this device; peer average 1.25/device2024-08: 0 reports for this device; peer average 1.22/device2024-09: 0 reports for this device; peer average 1.62/device2024-10: 0 reports for this device; peer average 1.87/device2024-11: 0 reports for this device; peer average 1.86/device2024-12: 0 reports for this device; peer average 1.89/device2025-01: 0 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 2/device2025-03: 0 reports for this device; peer average 1.33/device2025-04: 0 reports for this device; peer average 2.09/device2025-05: 0 reports for this device; peer average 2.15/device2025-06: 0 reports for this device; peer average 2.27/device2025-07: 0 reports for this device; peer average 1.6/device2025-08: 0 reports for this device; peer average 2.08/device2025-09: 0 reports for this device; peer average 2.25/device2025-10: 0 reports for this device; peer average 2.1/device2025-11: 0 reports for this device; peer average 2/device2025-12: 0 reports for this device; peer average 1.65/device2026-01: 0 reports for this device; peer average 1.67/device2026-02: 0 reports for this device; peer average 1.53/device2026-03: 0 reports for this device; peer average 2.23/device2026-04: 0 reports for this device; peer average 1.9/device2026-05: 0 reports for this device; peer average 1.93/device2026-06: 0 reports for this device; peer average 3.36/device010203040506070809101201020304060708091011010203040506070809101201020304050709100203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103
2019-0203
2019-0302
2019-0401.4
2019-0501.56
2019-0603
2019-0701.67
2019-0802.6
2019-0901.4
2019-1001
2019-1201.67
2020-0101.5
2020-0201.67
2020-0302.67
2020-0401.6
2020-0601
2020-0701.5
2020-0801
2020-0901
2020-1001.67
2020-1101.75
2021-0101.33
2021-0201.67
2021-0302
2021-0401
2021-0501
2021-0601
2021-0703
2021-0805
2021-0901
2021-1001
2021-1201
2022-0101.17
2022-0203
2022-0302
2022-0403
2022-0502.2
2022-0701
2022-0902.8
2022-1001
2023-0201
2023-0301.2
2023-0401.67
2023-0501.43
2023-0601.67
2023-0701.6
2023-0801.14
2023-0901.83
2023-1001.75
2023-1101.5
2023-1201.5
2024-0101.75
2024-0201.33
2024-0301.5
2024-0401.36
2024-0502.31
2024-0601.64
2024-0701.25
2024-0801.22
2024-0901.62
2024-1001.87
2024-1101.86
2024-1201.89
2025-0102
2025-0202
2025-0301.33
2025-0402.09
2025-0502.15
2025-0602.27
2025-0701.6
2025-0802.08
2025-0902.25
2025-1002.1
2025-1102
2025-1201.65
2026-0101.67
2026-0201.53
2026-0302.23
2026-0401.9
2026-0501.93
2026-0603.36
This device (reports/month)Average device in ELC (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Guilin Woodpecker Medical Instrument Co., Ltd.

  • VAI 2016-06-30 Guilin Woodpecker Medical Instrument Co., Ltd. · 2 citations
  • VAI 2016-06-30 Guilin Woodpecker Medical Instrument Co., Ltd. · 2 citations