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Unnamed device

Model 5100015250 · STRYKER CORPORATION · DI 04546540380272

EIA — Unit, Operative Dental · Class I · 21 CFR 872.6640

UDILibrary device dossier · generated 2026-09-08 · 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 (123)

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.

Malfunction: 122 · Injury: 1

24572019-01: 4 reports for this device; peer average 2.29/device2019-04: 3 reports for this device; peer average 1.83/device2019-06: 2 reports for this device; peer average 1.25/device2019-07: 4 reports for this device; peer average 2/device2019-10: 4 reports for this device; peer average 2/device2020-01: 3 reports for this device; peer average 1.86/device2020-04: 3 reports for this device; peer average 1.71/device2020-07: 4 reports for this device; peer average 1.83/device2020-10: 2 reports for this device; peer average 1.43/device2020-12: 0 reports for this device; peer average 1/device2021-01: 5 reports for this device; peer average 2.2/device2021-04: 4 reports for this device; peer average 2/device2021-07: 3 reports for this device; peer average 1.5/device2021-10: 3 reports for this device; peer average 2/device2022-01: 3 reports for this device; peer average 1.75/device2022-04: 5 reports for this device; peer average 2/device2022-07: 4 reports for this device; peer average 1.83/device2022-08: 1 reports for this device; peer average 1/device2022-09: 1 reports for this device; peer average 1/device2022-10: 5 reports for this device; peer average 2.14/device2023-01: 2 reports for this device; peer average 1.6/device2023-02: 0 reports for this device; peer average 1.5/device2023-04: 4 reports for this device; peer average 1.75/device2023-05: 0 reports for this device; peer average 2/device2023-06: 0 reports for this device; peer average 1/device2023-07: 5 reports for this device; peer average 2/device2023-09: 0 reports for this device; peer average 1/device2023-10: 5 reports for this device; peer average 2.2/device2024-01: 2 reports for this device; peer average 1.5/device2024-02: 2 reports for this device; peer average 2/device2024-03: 1 reports for this device; peer average 1/device2024-04: 4 reports for this device; peer average 2.4/device2024-07: 7 reports for this device; peer average 2.83/device2024-10: 5 reports for this device; peer average 1.8/device2025-01: 5 reports for this device; peer average 2.17/device2025-04: 4 reports for this device; peer average 2.33/device2025-07: 5 reports for this device; peer average 2.67/device2025-10: 3 reports for this device; peer average 2/device2025-12: 1 reports for this device; peer average 1/device2026-01: 3 reports for this device; peer average 2/device2026-04: 2 reports for this device; peer average 1.5/device0104060710010407101201040710010407080910010204050607091001020304071001040710120104
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0142.29
2019-0431.83
2019-0621.25
2019-0742
2019-1042
2020-0131.86
2020-0431.71
2020-0741.83
2020-1021.43
2020-1201
2021-0152.2
2021-0442
2021-0731.5
2021-1032
2022-0131.75
2022-0452
2022-0741.83
2022-0811
2022-0911
2022-1052.14
2023-0121.6
2023-0201.5
2023-0441.75
2023-0502
2023-0601
2023-0752
2023-0901
2023-1052.2
2024-0121.5
2024-0222
2024-0311
2024-0442.4
2024-0772.83
2024-1051.8
2025-0152.17
2025-0442.33
2025-0752.67
2025-1032
2025-1211
2026-0132
2026-0421.5
This device (reports/month)Average device in EIA (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — STRYKER CORPORATION

  • Warning Letter 2017-04-06 Entellus Medical Inc.
  • Warning Letter 2015-04-08 Thermedx LLC
  • Injunction 2013-11-26 Physio-Control, Inc.
  • Warning Letter 2013-03-06 Stryker Corporation
  • Warning Letter 2013-03-06 Stryker Corporation
  • NAI 2026-06-18 International Life Sciences · 0 citations
  • VAI 2026-02-20 Stryker Puerto Rico, LLC · 2 citations
  • NAI 2025-12-11 Stryker Manufacturing Kalamazoo · 0 citations
  • NAI 2025-05-22 Stryker Macroom · 0 citations
  • VAI 2025-03-27 Stryker GmbH · 1 citations
  • VAI 2025-03-27 Stryker GmbH · 1 citations
  • NAI 2025-02-27 Stryker Leibinger GmbH & Co. KG · 0 citations
  • NAI 2025-01-30 Serf · 0 citations
  • VAI 2024-12-18 Stryker Neurovascular · 1 citations
  • VAI 2024-11-15 Stryker Medical Division of Stryker Corporation · 2 citations
  • NAI 2024-11-13 POM Medical LLC · 0 citations
  • VAI 2024-07-25 Stryker Ireland, Ltd., Instruments Division · 1 citations
  • NAI 2024-05-03 Stryker Neurovascular, Inc. · 0 citations
  • NAI 2024-04-18 Physio-Control, Inc. · 0 citations
  • VAI 2023-12-01 Howmedica Osteonics Corp. · 1 citations
  • VAI 2023-05-15 LimFlow, Inc. · 2 citations
  • NAI 2023-04-25 Stryker Puerto Rico, LLC · 0 citations
  • VAI 2023-01-24 Stryker Corporation · 2 citations
  • VAI 2023-01-24 Stryker Corporation · 2 citations
  • VAI 2022-03-08 POM Medical LLC · 0 citations