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17ga LG, 73mm Always-On Tip Tracked Biopsy Needle, Chiba Point

Model INS-5035 · VERAN MEDICAL TECHNOLOGIES INC. · DI 00815686020927

JAK — System, X-Ray, Tomography, Computed · Class II · 21 CFR 892.1750

UDILibrary device dossier · generated 2026-09-07 · 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 5.1/device2019-02: 0 reports for this device; peer average 3.3/device2019-03: 0 reports for this device; peer average 3.25/device2019-04: 0 reports for this device; peer average 5.91/device2019-05: 0 reports for this device; peer average 3.25/device2019-06: 0 reports for this device; peer average 2.8/device2019-07: 0 reports for this device; peer average 2.58/device2019-08: 0 reports for this device; peer average 2.43/device2019-09: 0 reports for this device; peer average 2.14/device2019-10: 0 reports for this device; peer average 2.25/device2019-11: 0 reports for this device; peer average 1.86/device2019-12: 0 reports for this device; peer average 5.33/device2020-01: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 2.75/device2020-03: 0 reports for this device; peer average 2.2/device2020-04: 0 reports for this device; peer average 3.67/device2020-05: 0 reports for this device; peer average 2/device2020-06: 0 reports for this device; peer average 2.44/device2020-07: 0 reports for this device; peer average 2.25/device2020-08: 0 reports for this device; peer average 1.74/device2020-09: 0 reports for this device; peer average 2/device2020-10: 0 reports for this device; peer average 2.05/device2020-11: 0 reports for this device; peer average 2.24/device2020-12: 0 reports for this device; peer average 2.4/device2021-01: 0 reports for this device; peer average 1.47/device2021-02: 0 reports for this device; peer average 1.81/device2021-03: 0 reports for this device; peer average 2.43/device2021-04: 0 reports for this device; peer average 2.74/device2021-05: 0 reports for this device; peer average 3.77/device2021-06: 0 reports for this device; peer average 4.55/device2021-07: 0 reports for this device; peer average 3.07/device2021-08: 0 reports for this device; peer average 2.53/device2021-09: 0 reports for this device; peer average 2.3/device2021-10: 0 reports for this device; peer average 1.67/device2021-11: 0 reports for this device; peer average 2.62/device2021-12: 0 reports for this device; peer average 2.75/device2022-01: 0 reports for this device; peer average 1.89/device2022-02: 0 reports for this device; peer average 2.47/device2022-03: 0 reports for this device; peer average 2.43/device2022-04: 0 reports for this device; peer average 2.42/device2022-05: 0 reports for this device; peer average 1.89/device2022-06: 0 reports for this device; peer average 1.88/device2022-07: 0 reports for this device; peer average 3.53/device2022-08: 0 reports for this device; peer average 1.86/device2022-09: 0 reports for this device; peer average 2.84/device2022-10: 0 reports for this device; peer average 2.09/device2022-11: 0 reports for this device; peer average 2.07/device2022-12: 0 reports for this device; peer average 1.65/device2023-01: 0 reports for this device; peer average 2.31/device2023-02: 0 reports for this device; peer average 1.9/device2023-03: 0 reports for this device; peer average 2.63/device2023-04: 0 reports for this device; peer average 2.17/device2023-05: 0 reports for this device; peer average 2.57/device2023-06: 0 reports for this device; peer average 6.84/device2023-07: 0 reports for this device; peer average 2.1/device2023-08: 0 reports for this device; peer average 3.42/device2023-09: 0 reports for this device; peer average 2.95/device2023-10: 0 reports for this device; peer average 5.89/device2023-11: 0 reports for this device; peer average 2.58/device2023-12: 0 reports for this device; peer average 2.9/device2024-01: 0 reports for this device; peer average 1.9/device2024-02: 0 reports for this device; peer average 1.88/device2024-03: 0 reports for this device; peer average 1.89/device2024-04: 0 reports for this device; peer average 1.65/device2024-05: 0 reports for this device; peer average 2.06/device2024-06: 0 reports for this device; peer average 3.08/device2024-07: 0 reports for this device; peer average 1.88/device2024-08: 0 reports for this device; peer average 1.3/device2024-09: 0 reports for this device; peer average 1.17/device2024-10: 0 reports for this device; peer average 1.95/device2024-11: 0 reports for this device; peer average 1.45/device2024-12: 0 reports for this device; peer average 1.69/device2025-01: 0 reports for this device; peer average 1.59/device2025-02: 0 reports for this device; peer average 1.61/device2025-03: 0 reports for this device; peer average 1.39/device2025-04: 0 reports for this device; peer average 1.86/device2025-05: 0 reports for this device; peer average 2.5/device2025-06: 0 reports for this device; peer average 1.54/device2025-07: 0 reports for this device; peer average 1.5/device2025-08: 0 reports for this device; peer average 1.5/device2025-09: 0 reports for this device; peer average 1.67/device2025-10: 0 reports for this device; peer average 1.1/device2025-11: 0 reports for this device; peer average 1.29/device2025-12: 0 reports for this device; peer average 2.41/device2026-01: 0 reports for this device; peer average 2.22/device2026-02: 0 reports for this device; peer average 1.68/device2026-03: 0 reports for this device; peer average 1.45/device2026-04: 0 reports for this device; peer average 2/device2026-05: 0 reports for this device; peer average 2.19/device2026-06: 0 reports for this device; peer average 1.55/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0105.1
2019-0203.3
2019-0303.25
2019-0405.91
2019-0503.25
2019-0602.8
2019-0702.58
2019-0802.43
2019-0902.14
2019-1002.25
2019-1101.86
2019-1205.33
2020-0102
2020-0202.75
2020-0302.2
2020-0403.67
2020-0502
2020-0602.44
2020-0702.25
2020-0801.74
2020-0902
2020-1002.05
2020-1102.24
2020-1202.4
2021-0101.47
2021-0201.81
2021-0302.43
2021-0402.74
2021-0503.77
2021-0604.55
2021-0703.07
2021-0802.53
2021-0902.3
2021-1001.67
2021-1102.62
2021-1202.75
2022-0101.89
2022-0202.47
2022-0302.43
2022-0402.42
2022-0501.89
2022-0601.88
2022-0703.53
2022-0801.86
2022-0902.84
2022-1002.09
2022-1102.07
2022-1201.65
2023-0102.31
2023-0201.9
2023-0302.63
2023-0402.17
2023-0502.57
2023-0606.84
2023-0702.1
2023-0803.42
2023-0902.95
2023-1005.89
2023-1102.58
2023-1202.9
2024-0101.9
2024-0201.88
2024-0301.89
2024-0401.65
2024-0502.06
2024-0603.08
2024-0701.88
2024-0801.3
2024-0901.17
2024-1001.95
2024-1101.45
2024-1201.69
2025-0101.59
2025-0201.61
2025-0301.39
2025-0401.86
2025-0502.5
2025-0601.54
2025-0701.5
2025-0801.5
2025-0901.67
2025-1001.1
2025-1101.29
2025-1202.41
2026-0102.22
2026-0201.68
2026-0301.45
2026-0402
2026-0502.19
2026-0601.55
This device (reports/month)Average device in JAK (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — VERAN MEDICAL TECHNOLOGIES INC.

  • VAI 2023-02-23 Veran Medical Technologies Inc · 4 citations
  • VAI 2021-07-29 Veran Medical Technologies Inc · 0 citations
  • VAI 2019-01-31 Veran Medical Technologies Inc · 0 citations
  • VAI 2018-02-23 Veran Medical Technologies Inc · 0 citations
  • NAI 2015-02-04 Veran Medical Technologies Inc · 0 citations
  • NAI 2010-08-25 Veran Medical Technologies Inc · 0 citations