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AIM (Advanced Imaging Modality)

Model 0502937010 · STRYKER CORPORATION · DI 07613327063905

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 (9)

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: 9

61117222019-01: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 1/device2019-04: 0 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: 0 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: 0 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: 1 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: 0 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: 0 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: 0 reports for this device; peer average 2.88/device2021-07: 0 reports for this device; peer average 3.29/device2021-08: 0 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: 0 reports for this device; peer average 10.83/device2022-07: 0 reports for this device; peer average 5.57/device2022-08: 0 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: 1 reports for this device; peer average 4.63/device2023-03: 1 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: 0 reports for this device; peer average 4.7/device2023-07: 1 reports for this device; peer average 6.75/device2023-08: 0 reports for this device; peer average 8/device2023-09: 0 reports for this device; peer average 10.14/device2023-10: 0 reports for this device; peer average 7.44/device2023-11: 0 reports for this device; peer average 8.22/device2023-12: 0 reports for this device; peer average 8.88/device2024-01: 0 reports for this device; peer average 7.91/device2024-02: 0 reports for this device; peer average 15.86/device2024-03: 0 reports for this device; peer average 14/device2024-04: 0 reports for this device; peer average 11.11/device2024-05: 0 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: 0 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: 0 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)
2019-0101
2019-0301
2019-0402
2019-0502
2019-0601.67
2019-0701.5
2019-0811.5
2019-0901
2019-1002.75
2019-1102.5
2019-1205
2020-0101.67
2020-0202.5
2020-0301.67
2020-0401
2020-0501.5
2020-0604
2020-0702.17
2020-0812.2
2020-0902.6
2020-1003.33
2020-1102
2020-1202.33
2021-0103.4
2021-0202
2021-0303.43
2021-0405.4
2021-0512.88
2021-0602.88
2021-0703.29
2021-0803.38
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
2022-06010.83
2022-0705.57
2022-0804.4
2022-0903.9
2022-1004.38
2022-1105.9
2022-1214.75
2023-0105.29
2023-0214.63
2023-0316.27
2023-0407.25
2023-0507.75
2023-0604.7
2023-0716.75
2023-0808
2023-09010.14
2023-1007.44
2023-1108.22
2023-1208.88
2024-0107.91
2024-02015.86
2024-03014
2024-04011.11
2024-05011.71
2024-06018.83
2024-07022.4
2024-08013
2024-09012.86
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
2026-0603.87
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

K210088 — cites (transitively): K142310 (d1), K202592 (d1), K124031 (d2), K132785 (d2), K910132 (d2), K182160 (d2), K191046 (d2), K192292 (d2), K200310 (d2), K983566 (d3), K150956 (d3), K151243 (d3), K161792 (d3), K173866 (d3), K182606 (d3), K091515 (d4), K141077 (d4), K061548 (d4) — cited as predicate by K211202, K220108, K221217, K222079, K230886, K233635, K243008

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