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1588 AIM

Model 1588010000 · STRYKER CORPORATION · DI 07613327174328

OWN — Confocal Optical Imaging · Class II · 21 CFR 876.1500

UDILibrary device dossier · generated 2026-09-12 · 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 (35)

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: 33 · Injury: 2

61117222019-01: 1 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 1/device2019-04: 1 reports for this device; peer average 2/device2019-05: 0 reports for this device; peer average 2/device2019-06: 0 reports for this device; peer average 1.67/device2019-07: 2 reports for this device; peer average 1.5/device2019-08: 1 reports for this device; peer average 1.5/device2019-09: 0 reports for this device; peer average 1/device2019-10: 2 reports for this device; peer average 2.75/device2019-11: 0 reports for this device; peer average 2.5/device2019-12: 0 reports for this device; peer average 5/device2020-01: 0 reports for this device; peer average 1.67/device2020-02: 0 reports for this device; peer average 2.5/device2020-03: 0 reports for this device; peer average 1.67/device2020-04: 0 reports for this device; peer average 1/device2020-05: 0 reports for this device; peer average 1.5/device2020-06: 0 reports for this device; peer average 4/device2020-07: 0 reports for this device; peer average 2.17/device2020-08: 0 reports for this device; peer average 2.2/device2020-09: 0 reports for this device; peer average 2.6/device2020-10: 0 reports for this device; peer average 3.33/device2020-11: 1 reports for this device; peer average 2/device2020-12: 0 reports for this device; peer average 2.33/device2021-01: 0 reports for this device; peer average 3.4/device2021-02: 0 reports for this device; peer average 2/device2021-03: 1 reports for this device; peer average 3.43/device2021-04: 0 reports for this device; peer average 5.4/device2021-05: 1 reports for this device; peer average 2.88/device2021-06: 1 reports for this device; peer average 2.88/device2021-07: 0 reports for this device; peer average 3.29/device2021-08: 2 reports for this device; peer average 3.38/device2021-09: 0 reports for this device; peer average 4.25/device2021-10: 0 reports for this device; peer average 3/device2021-11: 0 reports for this device; peer average 3.29/device2021-12: 1 reports for this device; peer average 6/device2022-01: 0 reports for this device; peer average 3.71/device2022-02: 0 reports for this device; peer average 8.4/device2022-03: 0 reports for this device; peer average 6.33/device2022-04: 1 reports for this device; peer average 5.83/device2022-05: 0 reports for this device; peer average 12.63/device2022-06: 1 reports for this device; peer average 10.83/device2022-07: 0 reports for this device; peer average 5.57/device2022-08: 1 reports for this device; peer average 4.4/device2022-09: 0 reports for this device; peer average 3.9/device2022-10: 0 reports for this device; peer average 4.38/device2022-11: 0 reports for this device; peer average 5.9/device2022-12: 1 reports for this device; peer average 4.75/device2023-01: 0 reports for this device; peer average 5.29/device2023-02: 0 reports for this device; peer average 4.63/device2023-03: 0 reports for this device; peer average 6.27/device2023-04: 0 reports for this device; peer average 7.25/device2023-05: 0 reports for this device; peer average 7.75/device2023-06: 1 reports for this device; peer average 4.7/device2023-07: 0 reports for this device; peer average 6.75/device2023-08: 3 reports for this device; peer average 8/device2023-09: 0 reports for this device; peer average 10.14/device2023-10: 2 reports for this device; peer average 7.44/device2023-11: 2 reports for this device; peer average 8.22/device2023-12: 0 reports for this device; peer average 8.88/device2024-01: 1 reports for this device; peer average 7.91/device2024-02: 0 reports for this device; peer average 15.86/device2024-03: 3 reports for this device; peer average 14/device2024-04: 2 reports for this device; peer average 11.11/device2024-05: 1 reports for this device; peer average 11.71/device2024-06: 0 reports for this device; peer average 18.83/device2024-07: 0 reports for this device; peer average 22.4/device2024-08: 0 reports for this device; peer average 13/device2024-09: 1 reports for this device; peer average 12.86/device2024-10: 0 reports for this device; peer average 13.71/device2024-11: 0 reports for this device; peer average 6.25/device2024-12: 0 reports for this device; peer average 9.67/device2025-01: 0 reports for this device; peer average 8/device2025-02: 0 reports for this device; peer average 3.63/device2025-03: 0 reports for this device; peer average 5.5/device2025-04: 0 reports for this device; peer average 4.33/device2025-05: 0 reports for this device; peer average 4.4/device2025-06: 0 reports for this device; peer average 5/device2025-07: 0 reports for this device; peer average 6.88/device2025-08: 0 reports for this device; peer average 4.8/device2025-09: 0 reports for this device; peer average 3.83/device2025-10: 0 reports for this device; peer average 4.23/device2025-11: 0 reports for this device; peer average 3.71/device2025-12: 0 reports for this device; peer average 4.79/device2026-01: 0 reports for this device; peer average 4.9/device2026-02: 0 reports for this device; peer average 3.5/device2026-03: 0 reports for this device; peer average 4/device2026-04: 0 reports for this device; peer average 6.21/device2026-05: 0 reports for this device; peer average 4.2/device2026-06: 1 reports for this device; peer average 3.87/device0103040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0111
2019-0301
2019-0412
2019-0502
2019-0601.67
2019-0721.5
2019-0811.5
2019-0901
2019-1022.75
2019-1102.5
2019-1205
2020-0101.67
2020-0202.5
2020-0301.67
2020-0401
2020-0501.5
2020-0604
2020-0702.17
2020-0802.2
2020-0902.6
2020-1003.33
2020-1112
2020-1202.33
2021-0103.4
2021-0202
2021-0313.43
2021-0405.4
2021-0512.88
2021-0612.88
2021-0703.29
2021-0823.38
2021-0904.25
2021-1003
2021-1103.29
2021-1216
2022-0103.71
2022-0208.4
2022-0306.33
2022-0415.83
2022-05012.63
2022-06110.83
2022-0705.57
2022-0814.4
2022-0903.9
2022-1004.38
2022-1105.9
2022-1214.75
2023-0105.29
2023-0204.63
2023-0306.27
2023-0407.25
2023-0507.75
2023-0614.7
2023-0706.75
2023-0838
2023-09010.14
2023-1027.44
2023-1128.22
2023-1208.88
2024-0117.91
2024-02015.86
2024-03314
2024-04211.11
2024-05111.71
2024-06018.83
2024-07022.4
2024-08013
2024-09112.86
2024-10013.71
2024-1106.25
2024-1209.67
2025-0108
2025-0203.63
2025-0305.5
2025-0404.33
2025-0504.4
2025-0605
2025-0706.88
2025-0804.8
2025-0903.83
2025-1004.23
2025-1103.71
2025-1204.79
2026-0104.9
2026-0203.5
2026-0304
2026-0406.21
2026-0504.2
2026-0613.87
This device (reports/month)Average device in OWN (reports/device/month)

Regulatory clearances

  • K142310 SESE 2014-12-02 (k number procode)

Predicate lineage

K142310 — cites (transitively): K124031 (d1), K132785 (d1), K910132 (d1), K983566 (d2) — cited as predicate by K150956, K151243, K173866, K182160, K192292, K203550, K210088, K220108, K222079, K230886, K241401

Lineage extracted from public 510(k) summary text (heuristic).

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