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"MRI Integral ""T"" with Check Valve for MEDRAD® Spectris MR Injector"

Model SIT 96V · BAYER MEDICAL CARE INC. · DI 00616258010007

LNH — System, Nuclear Magnetic Resonance Imaging · Class II · 21 CFR 892.1000

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 (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.

24682019-02: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 2.5/device2019-04: 0 reports for this device; peer average 2.75/device2019-05: 0 reports for this device; peer average 1/device2019-06: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 1.4/device2019-11: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 1/device2020-03: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 1.6/device2020-08: 0 reports for this device; peer average 4/device2020-09: 0 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 1.5/device2021-01: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 1/device2021-07: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 1.33/device2021-10: 0 reports for this device; peer average 1.33/device2021-11: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 1/device2022-01: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 1.75/device2022-03: 0 reports for this device; peer average 1.13/device2022-04: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 1.33/device2022-07: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 1.25/device2022-10: 0 reports for this device; peer average 1.17/device2022-11: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1.33/device2023-01: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 1.33/device2023-03: 0 reports for this device; peer average 2.9/device2023-04: 0 reports for this device; peer average 1.5/device2023-05: 0 reports for this device; peer average 1.9/device2023-06: 0 reports for this device; peer average 1.5/device2023-07: 0 reports for this device; peer average 1.38/device2023-08: 0 reports for this device; peer average 2.17/device2023-09: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 1.57/device2023-11: 0 reports for this device; peer average 2/device2023-12: 0 reports for this device; peer average 1.2/device2024-01: 0 reports for this device; peer average 1.2/device2024-02: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1.33/device2024-04: 0 reports for this device; peer average 1.25/device2024-05: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 1.33/device2024-08: 0 reports for this device; peer average 1.5/device2024-09: 0 reports for this device; peer average 1.17/device2024-10: 0 reports for this device; peer average 1.33/device2024-11: 0 reports for this device; peer average 1.78/device2024-12: 0 reports for this device; peer average 1.21/device2025-01: 0 reports for this device; peer average 4.86/device2025-02: 0 reports for this device; peer average 3.38/device2025-03: 0 reports for this device; peer average 2.36/device2025-04: 0 reports for this device; peer average 2/device2025-05: 0 reports for this device; peer average 2.35/device2025-06: 0 reports for this device; peer average 5/device2025-07: 0 reports for this device; peer average 5.64/device2025-08: 0 reports for this device; peer average 7.95/device2025-09: 0 reports for this device; peer average 4.53/device2025-10: 0 reports for this device; peer average 5.21/device2025-11: 0 reports for this device; peer average 4.11/device2025-12: 0 reports for this device; peer average 7.12/device2026-01: 0 reports for this device; peer average 5.95/device2026-02: 0 reports for this device; peer average 3.8/device2026-03: 0 reports for this device; peer average 3.48/device2026-04: 0 reports for this device; peer average 3.97/device2026-05: 0 reports for this device; peer average 6.61/device2026-06: 0 reports for this device; peer average 3.1/device0203040506071011120203070809101201020305070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0201
2019-0302.5
2019-0402.75
2019-0501
2019-0601
2019-0702
2019-1001.4
2019-1101
2019-1201
2020-0201
2020-0301
2020-0701.6
2020-0804
2020-0901
2020-1001
2020-1201.5
2021-0101
2021-0201
2021-0301
2021-0501
2021-0701
2021-0801
2021-0901.33
2021-1001.33
2021-1101
2021-1201
2022-0101
2022-0201.75
2022-0301.13
2022-0401
2022-0501
2022-0601.33
2022-0701
2022-0801
2022-0901.25
2022-1001.17
2022-1101
2022-1201.33
2023-0101
2023-0201.33
2023-0302.9
2023-0401.5
2023-0501.9
2023-0601.5
2023-0701.38
2023-0802.17
2023-0902
2023-1001.57
2023-1102
2023-1201.2
2024-0101.2
2024-0201
2024-0301.33
2024-0401.25
2024-0501
2024-0601
2024-0701.33
2024-0801.5
2024-0901.17
2024-1001.33
2024-1101.78
2024-1201.21
2025-0104.86
2025-0203.38
2025-0302.36
2025-0402
2025-0502.35
2025-0605
2025-0705.64
2025-0807.95
2025-0904.53
2025-1005.21
2025-1104.11
2025-1207.12
2026-0105.95
2026-0203.8
2026-0303.48
2026-0403.97
2026-0506.61
2026-0603.1
This device (reports/month)Average device in LNH (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — BAYER MEDICAL CARE INC.

  • Warning Letter 2011-05-19 Bayer Medical Care, Inc.
  • Warning Letter 2011-05-19 Bayer Medical Care, Inc.
  • NAI 2018-08-17 Bayer Medical Care, Inc. · 0 citations
  • NAI 2018-08-17 Bayer Medical Care, Inc. · 0 citations
  • NAI 2017-01-19 Bayer Medical Care, Inc. · 0 citations
  • NAI 2017-01-19 Bayer Medical Care, Inc. · 0 citations
  • NAI 2017-01-18 Bayer Medical Care, Inc. · 0 citations
  • NAI 2017-01-18 Bayer Medical Care, Inc. · 0 citations
  • NAI 2017-01-06 Bayer Medical Care, Inc. · 0 citations
  • NAI 2017-01-06 Bayer Medical Care, Inc. · 0 citations
  • NAI 2015-04-16 Bayer Medical SRL · 0 citations
  • NAI 2014-03-20 Bayer Medical Care Inc. · 0 citations
  • NAI 2013-08-12 Bayer Medical Care, Inc. · 0 citations
  • NAI 2013-08-12 Bayer Medical Care, Inc. · 0 citations
  • NAI 2013-08-07 Bayer Medical Care, Inc. · 0 citations
  • NAI 2013-08-07 Bayer Medical Care, Inc. · 0 citations
  • NAI 2013-08-01 Bayer Medical Care, Inc. · 0 citations
  • NAI 2013-08-01 Bayer Medical Care, Inc. · 0 citations
  • NAI 2012-05-02 Bayer Medical Care, Inc. · 0 citations
  • NAI 2012-05-02 Bayer Medical Care, Inc. · 0 citations
  • NAI 2011-08-23 Bayer Medical Care, Inc. · 0 citations
  • NAI 2011-08-23 Bayer Medical Care, Inc. · 0 citations