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3-Ch ECG Holter Patient Cable w/7 Leads

Model Model 1303 · VASOMEDICAL, INC. · DI 00817980020573

DSH — Recorder, Magnetic Tape, Medical · Class II · 21 CFR 870.2800

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.

102030402019-01: 0 reports for this device; peer average 8/device2019-02: 0 reports for this device; peer average 2.5/device2019-03: 0 reports for this device; peer average 22/device2019-04: 0 reports for this device; peer average 16/device2019-05: 0 reports for this device; peer average 12/device2019-06: 0 reports for this device; peer average 17/device2019-07: 0 reports for this device; peer average 8/device2019-08: 0 reports for this device; peer average 7/device2019-09: 0 reports for this device; peer average 7.67/device2019-10: 0 reports for this device; peer average 5/device2019-11: 0 reports for this device; peer average 4/device2019-12: 0 reports for this device; peer average 4.5/device2020-01: 0 reports for this device; peer average 31/device2020-02: 0 reports for this device; peer average 21/device2020-03: 0 reports for this device; peer average 15/device2020-04: 0 reports for this device; peer average 12/device2020-05: 0 reports for this device; peer average 6/device2020-06: 0 reports for this device; peer average 10.5/device2020-07: 0 reports for this device; peer average 21/device2020-08: 0 reports for this device; peer average 11/device2020-09: 0 reports for this device; peer average 33/device2020-10: 0 reports for this device; peer average 13.5/device2020-11: 0 reports for this device; peer average 22/device2020-12: 0 reports for this device; peer average 33/device2021-01: 0 reports for this device; peer average 9/device2021-02: 0 reports for this device; peer average 10/device2021-03: 0 reports for this device; peer average 22/device2021-04: 0 reports for this device; peer average 16/device2021-05: 0 reports for this device; peer average 30/device2021-06: 0 reports for this device; peer average 33/device2021-07: 0 reports for this device; peer average 16.5/device2021-08: 0 reports for this device; peer average 24/device2021-09: 0 reports for this device; peer average 5.5/device2021-10: 0 reports for this device; peer average 3/device2021-11: 0 reports for this device; peer average 3.5/device2021-12: 0 reports for this device; peer average 5.5/device2022-01: 0 reports for this device; peer average 5/device2022-02: 0 reports for this device; peer average 8.5/device2022-03: 0 reports for this device; peer average 7/device2022-04: 0 reports for this device; peer average 2.5/device2022-05: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 2/device2022-08: 0 reports for this device; peer average 1.5/device2022-09: 0 reports for this device; peer average 2.5/device2023-04: 0 reports for this device; peer average 1/device2023-06: 0 reports for this device; peer average 2/device2023-07: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 1.75/device2023-11: 0 reports for this device; peer average 8.5/device2023-12: 0 reports for this device; peer average 17.25/device2024-01: 0 reports for this device; peer average 12.25/device2024-02: 0 reports for this device; peer average 16.67/device2024-03: 0 reports for this device; peer average 13.5/device2024-04: 0 reports for this device; peer average 28.5/device2024-05: 0 reports for this device; peer average 22/device2024-06: 0 reports for this device; peer average 32.33/device2024-07: 0 reports for this device; peer average 4.67/device2024-08: 0 reports for this device; peer average 7.75/device2024-09: 0 reports for this device; peer average 4.5/device2024-10: 0 reports for this device; peer average 9/device2024-11: 0 reports for this device; peer average 5.75/device2024-12: 0 reports for this device; peer average 4.2/device2025-01: 0 reports for this device; peer average 8.5/device2025-02: 0 reports for this device; peer average 7.67/device2025-03: 0 reports for this device; peer average 8.67/device2025-04: 0 reports for this device; peer average 13/device2025-05: 0 reports for this device; peer average 14/device2025-06: 0 reports for this device; peer average 9.67/device2025-07: 0 reports for this device; peer average 11.67/device2025-08: 0 reports for this device; peer average 11.6/device2025-09: 0 reports for this device; peer average 13/device2025-10: 0 reports for this device; peer average 6.75/device2025-11: 0 reports for this device; peer average 24/device2025-12: 0 reports for this device; peer average 24.67/device2026-01: 0 reports for this device; peer average 19.67/device2026-02: 0 reports for this device; peer average 40/device2026-03: 0 reports for this device; peer average 28.5/device2026-04: 0 reports for this device; peer average 40/device2026-05: 0 reports for this device; peer average 14/device2026-06: 0 reports for this device; peer average 3/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809040607101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0108
2019-0202.5
2019-03022
2019-04016
2019-05012
2019-06017
2019-0708
2019-0807
2019-0907.67
2019-1005
2019-1104
2019-1204.5
2020-01031
2020-02021
2020-03015
2020-04012
2020-0506
2020-06010.5
2020-07021
2020-08011
2020-09033
2020-10013.5
2020-11022
2020-12033
2021-0109
2021-02010
2021-03022
2021-04016
2021-05030
2021-06033
2021-07016.5
2021-08024
2021-0905.5
2021-1003
2021-1103.5
2021-1205.5
2022-0105
2022-0208.5
2022-0307
2022-0402.5
2022-0501
2022-0601
2022-0702
2022-0801.5
2022-0902.5
2023-0401
2023-0602
2023-0701
2023-1001.75
2023-1108.5
2023-12017.25
2024-01012.25
2024-02016.67
2024-03013.5
2024-04028.5
2024-05022
2024-06032.33
2024-0704.67
2024-0807.75
2024-0904.5
2024-1009
2024-1105.75
2024-1204.2
2025-0108.5
2025-0207.67
2025-0308.67
2025-04013
2025-05014
2025-0609.67
2025-07011.67
2025-08011.6
2025-09013
2025-1006.75
2025-11024
2025-12024.67
2026-01019.67
2026-02040
2026-03028.5
2026-04040
2026-05014
2026-0603
This device (reports/month)Average device in DSH (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — VASOMEDICAL, INC.

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