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SmartLife

Model 7126-120-000 · STRYKER CORPORATION · DI 07613327128819

HWE — Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment · Class I · 21 CFR 878.4820

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 (1010)

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: 1009 · Injury: 1

122435472019-01: 17 reports for this device; peer average 2.57/device2019-02: 11 reports for this device; peer average 3.34/device2019-03: 12 reports for this device; peer average 3.74/device2019-04: 24 reports for this device; peer average 3.75/device2019-05: 17 reports for this device; peer average 4.47/device2019-06: 30 reports for this device; peer average 4.34/device2019-07: 28 reports for this device; peer average 3.28/device2019-08: 13 reports for this device; peer average 4.2/device2019-09: 12 reports for this device; peer average 4.39/device2019-10: 21 reports for this device; peer average 3.55/device2019-11: 18 reports for this device; peer average 4.17/device2019-12: 44 reports for this device; peer average 5.23/device2020-01: 15 reports for this device; peer average 3.83/device2020-02: 34 reports for this device; peer average 3.67/device2020-03: 46 reports for this device; peer average 5.43/device2020-04: 5 reports for this device; peer average 3.18/device2020-05: 4 reports for this device; peer average 3.39/device2020-06: 12 reports for this device; peer average 4.09/device2020-07: 32 reports for this device; peer average 3.35/device2020-08: 5 reports for this device; peer average 3.7/device2020-09: 25 reports for this device; peer average 4.4/device2020-10: 39 reports for this device; peer average 3.63/device2020-11: 29 reports for this device; peer average 4.26/device2020-12: 20 reports for this device; peer average 4.09/device2021-01: 47 reports for this device; peer average 3.41/device2021-02: 36 reports for this device; peer average 4.44/device2021-03: 35 reports for this device; peer average 4.14/device2021-04: 26 reports for this device; peer average 3.52/device2021-05: 25 reports for this device; peer average 4.14/device2021-06: 22 reports for this device; peer average 3.6/device2021-07: 12 reports for this device; peer average 3.14/device2021-08: 5 reports for this device; peer average 3.47/device2021-09: 12 reports for this device; peer average 2.94/device2021-10: 23 reports for this device; peer average 2.63/device2021-11: 21 reports for this device; peer average 3.19/device2021-12: 11 reports for this device; peer average 3.45/device2022-01: 7 reports for this device; peer average 2.89/device2022-02: 11 reports for this device; peer average 3.3/device2022-03: 7 reports for this device; peer average 3.73/device2022-04: 10 reports for this device; peer average 2.83/device2022-05: 8 reports for this device; peer average 3.4/device2022-06: 8 reports for this device; peer average 4.17/device2022-07: 7 reports for this device; peer average 3.03/device2022-08: 2 reports for this device; peer average 3.61/device2022-09: 7 reports for this device; peer average 4.98/device2022-10: 11 reports for this device; peer average 3.59/device2022-11: 8 reports for this device; peer average 4.13/device2022-12: 13 reports for this device; peer average 4.95/device2023-01: 5 reports for this device; peer average 2.81/device2023-02: 8 reports for this device; peer average 3.85/device2023-03: 7 reports for this device; peer average 3.68/device2023-04: 5 reports for this device; peer average 2.81/device2023-05: 7 reports for this device; peer average 4.17/device2023-06: 10 reports for this device; peer average 3.98/device2023-07: 5 reports for this device; peer average 3.25/device2023-08: 3 reports for this device; peer average 3.57/device2023-09: 3 reports for this device; peer average 3.49/device2023-10: 7 reports for this device; peer average 2.42/device2023-11: 4 reports for this device; peer average 4.39/device2023-12: 1 reports for this device; peer average 3.49/device2024-01: 14 reports for this device; peer average 2.91/device2024-02: 10 reports for this device; peer average 4.27/device2024-03: 3 reports for this device; peer average 3.3/device2024-04: 3 reports for this device; peer average 3.03/device2024-05: 3 reports for this device; peer average 4.22/device2024-06: 1 reports for this device; peer average 4.45/device2024-07: 3 reports for this device; peer average 2.76/device2024-08: 1 reports for this device; peer average 2.79/device2024-09: 1 reports for this device; peer average 4.14/device2024-10: 4 reports for this device; peer average 3/device2024-11: 2 reports for this device; peer average 2.93/device2024-12: 0 reports for this device; peer average 2.89/device2025-01: 6 reports for this device; peer average 2.91/device2025-02: 0 reports for this device; peer average 3.61/device2025-03: 0 reports for this device; peer average 3.28/device2025-04: 2 reports for this device; peer average 2.08/device2025-05: 2 reports for this device; peer average 4.03/device2025-06: 0 reports for this device; peer average 3.53/device2025-07: 1 reports for this device; peer average 2.85/device2025-08: 0 reports for this device; peer average 2.92/device2025-09: 0 reports for this device; peer average 2.57/device2025-10: 2 reports for this device; peer average 2.56/device2025-11: 0 reports for this device; peer average 4.02/device2025-12: 0 reports for this device; peer average 3.39/device2026-01: 0 reports for this device; peer average 2.42/device2026-02: 0 reports for this device; peer average 2.96/device2026-03: 0 reports for this device; peer average 3.04/device2026-04: 0 reports for this device; peer average 3.55/device2026-05: 0 reports for this device; peer average 3.26/device2026-06: 0 reports for this device; peer average 2.64/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-01172.57
2019-02113.34
2019-03123.74
2019-04243.75
2019-05174.47
2019-06304.34
2019-07283.28
2019-08134.2
2019-09124.39
2019-10213.55
2019-11184.17
2019-12445.23
2020-01153.83
2020-02343.67
2020-03465.43
2020-0453.18
2020-0543.39
2020-06124.09
2020-07323.35
2020-0853.7
2020-09254.4
2020-10393.63
2020-11294.26
2020-12204.09
2021-01473.41
2021-02364.44
2021-03354.14
2021-04263.52
2021-05254.14
2021-06223.6
2021-07123.14
2021-0853.47
2021-09122.94
2021-10232.63
2021-11213.19
2021-12113.45
2022-0172.89
2022-02113.3
2022-0373.73
2022-04102.83
2022-0583.4
2022-0684.17
2022-0773.03
2022-0823.61
2022-0974.98
2022-10113.59
2022-1184.13
2022-12134.95
2023-0152.81
2023-0283.85
2023-0373.68
2023-0452.81
2023-0574.17
2023-06103.98
2023-0753.25
2023-0833.57
2023-0933.49
2023-1072.42
2023-1144.39
2023-1213.49
2024-01142.91
2024-02104.27
2024-0333.3
2024-0433.03
2024-0534.22
2024-0614.45
2024-0732.76
2024-0812.79
2024-0914.14
2024-1043
2024-1122.93
2024-1202.89
2025-0162.91
2025-0203.61
2025-0303.28
2025-0422.08
2025-0524.03
2025-0603.53
2025-0712.85
2025-0802.92
2025-0902.57
2025-1022.56
2025-1104.02
2025-1203.39
2026-0102.42
2026-0202.96
2026-0303.04
2026-0403.55
2026-0503.26
2026-0602.64
This device (reports/month)Average device in HWE (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