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Synchro SELECT
Model SSFT300PRE · Stryker Corporation · DI 07613327508604
DQX — Wire, Guide, Catheter · Class II · 21 CFR 870.1330
MOF — Guide, Wire, Catheter, Neurovasculature · Class II · 21 CFR 870.1330
UDILibrary device dossier · generated 2026-09-11 · 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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
1.64
2019-02
0
1.52
2019-03
0
1.76
2019-04
0
1.69
2019-05
0
1.69
2019-06
0
1.55
2019-07
0
2.02
2019-08
0
2.38
2019-09
0
2.08
2019-10
0
2.24
2019-11
0
2.03
2019-12
0
2.52
2020-01
0
2.27
2020-02
0
2.9
2020-03
0
2.85
2020-04
0
2.16
2020-05
0
2.68
2020-06
0
2.46
2020-07
0
2.83
2020-08
0
2.54
2020-09
0
2.39
2020-10
0
2.62
2020-11
0
2.65
2020-12
0
2.71
2021-01
0
3
2021-02
0
2.12
2021-03
0
2.65
2021-04
0
2.6
2021-05
0
2.02
2021-06
0
2.4
2021-07
0
2.95
2021-08
0
2.36
2021-09
0
2.32
2021-10
0
1.97
2021-11
0
2.33
2021-12
0
2.59
2022-01
0
2.58
2022-02
0
2.37
2022-03
0
2.41
2022-04
0
2.51
2022-05
0
2.78
2022-06
0
2.69
2022-07
0
2.47
2022-08
0
2.92
2022-09
0
2.5
2022-10
0
2.18
2022-11
0
2.58
2022-12
0
2.33
2023-01
0
1.86
2023-02
0
2.53
2023-03
0
2.51
2023-04
0
2.18
2023-05
0
2.87
2023-06
0
2.34
2023-07
0
2.57
2023-08
0
2.62
2023-09
0
2.63
2023-10
0
2.51
2023-11
0
2.55
2023-12
0
2.68
2024-01
0
2.57
2024-02
0
2.6
2024-03
0
2.76
2024-04
0
2.2
2024-05
0
3.17
2024-06
0
2.94
2024-07
0
2.24
2024-08
0
3.44
2024-09
0
2.96
2024-10
0
3.8
2024-11
0
3.29
2024-12
0
3.67
2025-01
0
2.94
2025-02
0
3.07
2025-03
0
3.1
2025-04
0
3.32
2025-05
0
3.15
2025-06
0
2.88
2025-07
0
2.97
2025-08
0
3.12
2025-09
0
3.33
2025-10
0
3.11
2025-11
0
3.84
2025-12
0
4.14
2026-01
0
3.52
2026-02
0
3.82
2026-03
0
3.83
2026-04
0
2.94
2026-05
0
2.6
2026-06
0
2.77
This device (reports/month)Average device in DQX, MOF (reports/device/month)