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MEDRAD® Mark V ProVis 200mL FasTurn Sterile Disposable Syringe & QFT

Model 200-FT-Q · Bayer Medical Care Inc. · DI 00616258024349

DXT — Injector And Syringe, Angiographic · Class II · 21 CFR 870.1650

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.

23572019-01: 0 reports for this device; peer average 1.76/device2019-02: 0 reports for this device; peer average 1.38/device2019-03: 0 reports for this device; peer average 1.64/device2019-04: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 1.17/device2019-06: 0 reports for this device; peer average 3/device2019-07: 0 reports for this device; peer average 1.83/device2019-08: 0 reports for this device; peer average 1.53/device2019-09: 0 reports for this device; peer average 1.05/device2019-10: 0 reports for this device; peer average 1.75/device2019-11: 0 reports for this device; peer average 1.36/device2019-12: 0 reports for this device; peer average 1.7/device2020-01: 0 reports for this device; peer average 1.91/device2020-02: 0 reports for this device; peer average 1.44/device2020-03: 0 reports for this device; peer average 1.52/device2020-04: 0 reports for this device; peer average 3.33/device2020-05: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 1.5/device2020-07: 0 reports for this device; peer average 2.25/device2020-08: 0 reports for this device; peer average 1.6/device2020-09: 0 reports for this device; peer average 1.63/device2020-10: 0 reports for this device; peer average 1.92/device2020-11: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 2.5/device2021-01: 0 reports for this device; peer average 1.25/device2021-02: 0 reports for this device; peer average 2.93/device2021-03: 0 reports for this device; peer average 1.25/device2021-04: 0 reports for this device; peer average 1.91/device2021-05: 0 reports for this device; peer average 1.42/device2021-06: 0 reports for this device; peer average 2.31/device2021-07: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 1.69/device2021-09: 0 reports for this device; peer average 1.5/device2021-10: 0 reports for this device; peer average 1.14/device2021-11: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 1.27/device2022-01: 0 reports for this device; peer average 1.63/device2022-02: 0 reports for this device; peer average 1.63/device2022-03: 0 reports for this device; peer average 1.17/device2022-04: 0 reports for this device; peer average 2.8/device2022-05: 0 reports for this device; peer average 3/device2022-06: 0 reports for this device; peer average 1.71/device2022-07: 0 reports for this device; peer average 1.38/device2022-08: 0 reports for this device; peer average 1.5/device2022-09: 0 reports for this device; peer average 1.7/device2022-10: 0 reports for this device; peer average 1.14/device2022-11: 0 reports for this device; peer average 1.22/device2022-12: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 2/device2023-04: 0 reports for this device; peer average 1.29/device2023-05: 0 reports for this device; peer average 1/device2023-06: 0 reports for this device; peer average 6.5/device2023-07: 0 reports for this device; peer average 1.67/device2023-08: 0 reports for this device; peer average 2.33/device2023-09: 0 reports for this device; peer average 4.83/device2023-10: 0 reports for this device; peer average 1.18/device2023-11: 0 reports for this device; peer average 3.5/device2023-12: 0 reports for this device; peer average 2.29/device2024-01: 0 reports for this device; peer average 1.08/device2024-02: 0 reports for this device; peer average 1.14/device2024-03: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 3.5/device2024-06: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 2.5/device2024-08: 0 reports for this device; peer average 2.5/device2024-09: 0 reports for this device; peer average 1.15/device2024-10: 0 reports for this device; peer average 2.2/device2024-11: 0 reports for this device; peer average 1.33/device2024-12: 0 reports for this device; peer average 2.5/device2025-01: 0 reports for this device; peer average 1.29/device2025-02: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 1.6/device2025-04: 0 reports for this device; peer average 1.5/device2025-05: 0 reports for this device; peer average 1/device2025-06: 0 reports for this device; peer average 1.4/device2025-07: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 1.5/device2025-09: 0 reports for this device; peer average 1.75/device2025-10: 0 reports for this device; peer average 1.25/device2025-11: 0 reports for this device; peer average 1.57/device2025-12: 0 reports for this device; peer average 1.13/device2026-01: 0 reports for this device; peer average 3.2/device2026-02: 0 reports for this device; peer average 5.43/device2026-03: 0 reports for this device; peer average 4.8/device2026-04: 0 reports for this device; peer average 1.2/device2026-05: 0 reports for this device; peer average 1.5/device2026-06: 0 reports for this device; peer average 1.17/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.76
2019-0201.38
2019-0301.64
2019-0401
2019-0501.17
2019-0603
2019-0701.83
2019-0801.53
2019-0901.05
2019-1001.75
2019-1101.36
2019-1201.7
2020-0101.91
2020-0201.44
2020-0301.52
2020-0403.33
2020-0501
2020-0601.5
2020-0702.25
2020-0801.6
2020-0901.63
2020-1001.92
2020-1101
2020-1202.5
2021-0101.25
2021-0202.93
2021-0301.25
2021-0401.91
2021-0501.42
2021-0602.31
2021-0702
2021-0801.69
2021-0901.5
2021-1001.14
2021-1101
2021-1201.27
2022-0101.63
2022-0201.63
2022-0301.17
2022-0402.8
2022-0503
2022-0601.71
2022-0701.38
2022-0801.5
2022-0901.7
2022-1001.14
2022-1101.22
2022-1201
2023-0101
2023-0201
2023-0302
2023-0401.29
2023-0501
2023-0606.5
2023-0701.67
2023-0802.33
2023-0904.83
2023-1001.18
2023-1103.5
2023-1202.29
2024-0101.08
2024-0201.14
2024-0301
2024-0401
2024-0503.5
2024-0601
2024-0702.5
2024-0802.5
2024-0901.15
2024-1002.2
2024-1101.33
2024-1202.5
2025-0101.29
2025-0201
2025-0301.6
2025-0401.5
2025-0501
2025-0601.4
2025-0701
2025-0801.5
2025-0901.75
2025-1001.25
2025-1101.57
2025-1201.13
2026-0103.2
2026-0205.43
2026-0304.8
2026-0401.2
2026-0501.5
2026-0601.17
This device (reports/month)Average device in DXT (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K822536 — cited as predicate by K170279, K192657, K211564, K241109, K253048

Lineage extracted from public 510(k) summary text (heuristic).

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