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Model IPN036055 · TELEFLEX INCORPORATED · DI 00801902111470

OBJ — Catheter, Ultrasound, Intravascular · Class II · 21 CFR 870.1200

UDILibrary device dossier · generated 2026-09-14 · 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.

257102019-01: 0 reports for this device; peer average 1.7/device2019-02: 0 reports for this device; peer average 1.5/device2019-03: 0 reports for this device; peer average 1.5/device2019-04: 0 reports for this device; peer average 3.14/device2019-05: 0 reports for this device; peer average 1.2/device2019-06: 0 reports for this device; peer average 1.5/device2019-07: 0 reports for this device; peer average 1.78/device2019-08: 0 reports for this device; peer average 2.29/device2019-09: 0 reports for this device; peer average 1.6/device2019-10: 0 reports for this device; peer average 2.75/device2019-11: 0 reports for this device; peer average 3.4/device2019-12: 0 reports for this device; peer average 2.17/device2020-01: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 2.78/device2020-03: 0 reports for this device; peer average 2.5/device2020-04: 0 reports for this device; peer average 2/device2020-05: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 2.38/device2020-07: 0 reports for this device; peer average 3.2/device2020-08: 0 reports for this device; peer average 2.5/device2020-09: 0 reports for this device; peer average 3.57/device2020-10: 0 reports for this device; peer average 2/device2020-11: 0 reports for this device; peer average 2.57/device2020-12: 0 reports for this device; peer average 3.2/device2021-01: 0 reports for this device; peer average 2.67/device2021-02: 0 reports for this device; peer average 3.78/device2021-03: 0 reports for this device; peer average 2.5/device2021-04: 0 reports for this device; peer average 3.23/device2021-05: 0 reports for this device; peer average 2.91/device2021-06: 0 reports for this device; peer average 2.5/device2021-07: 0 reports for this device; peer average 3.4/device2021-08: 0 reports for this device; peer average 1.91/device2021-09: 0 reports for this device; peer average 2.62/device2021-10: 0 reports for this device; peer average 3.73/device2021-11: 0 reports for this device; peer average 2.82/device2021-12: 0 reports for this device; peer average 2.36/device2022-01: 0 reports for this device; peer average 2.2/device2022-02: 0 reports for this device; peer average 4/device2022-03: 0 reports for this device; peer average 3.36/device2022-04: 0 reports for this device; peer average 2.47/device2022-05: 0 reports for this device; peer average 2.7/device2022-06: 0 reports for this device; peer average 2.36/device2022-07: 0 reports for this device; peer average 2.38/device2022-08: 0 reports for this device; peer average 3.08/device2022-09: 0 reports for this device; peer average 4.43/device2022-10: 0 reports for this device; peer average 9.78/device2022-11: 0 reports for this device; peer average 2.79/device2022-12: 0 reports for this device; peer average 2.13/device2023-01: 0 reports for this device; peer average 2.94/device2023-02: 0 reports for this device; peer average 2.35/device2023-03: 0 reports for this device; peer average 4.57/device2023-04: 0 reports for this device; peer average 3.16/device2023-05: 0 reports for this device; peer average 3.15/device2023-06: 0 reports for this device; peer average 3/device2023-07: 0 reports for this device; peer average 3.24/device2023-08: 0 reports for this device; peer average 3.5/device2023-09: 0 reports for this device; peer average 2.71/device2023-10: 0 reports for this device; peer average 4.25/device2023-11: 0 reports for this device; peer average 4.35/device2023-12: 0 reports for this device; peer average 4.33/device2024-01: 0 reports for this device; peer average 8.47/device2024-02: 0 reports for this device; peer average 4.54/device2024-03: 0 reports for this device; peer average 5.08/device2024-04: 0 reports for this device; peer average 5.24/device2024-05: 0 reports for this device; peer average 4.59/device2024-06: 0 reports for this device; peer average 4.71/device2024-07: 0 reports for this device; peer average 3.95/device2024-08: 0 reports for this device; peer average 2.72/device2024-09: 0 reports for this device; peer average 3.68/device2024-10: 0 reports for this device; peer average 2.86/device2024-11: 0 reports for this device; peer average 4.1/device2024-12: 0 reports for this device; peer average 4.11/device2025-01: 0 reports for this device; peer average 4.18/device2025-02: 0 reports for this device; peer average 3.71/device2025-03: 0 reports for this device; peer average 4.25/device2025-04: 0 reports for this device; peer average 2.97/device2025-05: 0 reports for this device; peer average 4.84/device2025-06: 0 reports for this device; peer average 4.23/device2025-07: 0 reports for this device; peer average 4.62/device2025-08: 0 reports for this device; peer average 3.85/device2025-09: 0 reports for this device; peer average 5.33/device2025-10: 0 reports for this device; peer average 5.63/device2025-11: 0 reports for this device; peer average 3.9/device2025-12: 0 reports for this device; peer average 6.91/device2026-01: 0 reports for this device; peer average 4.47/device2026-02: 0 reports for this device; peer average 5.24/device2026-03: 0 reports for this device; peer average 5.22/device2026-04: 0 reports for this device; peer average 5.67/device2026-05: 0 reports for this device; peer average 3.84/device2026-06: 0 reports for this device; peer average 5.86/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.7
2019-0201.5
2019-0301.5
2019-0403.14
2019-0501.2
2019-0601.5
2019-0701.78
2019-0802.29
2019-0901.6
2019-1002.75
2019-1103.4
2019-1202.17
2020-0101
2020-0202.78
2020-0302.5
2020-0402
2020-0501
2020-0602.38
2020-0703.2
2020-0802.5
2020-0903.57
2020-1002
2020-1102.57
2020-1203.2
2021-0102.67
2021-0203.78
2021-0302.5
2021-0403.23
2021-0502.91
2021-0602.5
2021-0703.4
2021-0801.91
2021-0902.62
2021-1003.73
2021-1102.82
2021-1202.36
2022-0102.2
2022-0204
2022-0303.36
2022-0402.47
2022-0502.7
2022-0602.36
2022-0702.38
2022-0803.08
2022-0904.43
2022-1009.78
2022-1102.79
2022-1202.13
2023-0102.94
2023-0202.35
2023-0304.57
2023-0403.16
2023-0503.15
2023-0603
2023-0703.24
2023-0803.5
2023-0902.71
2023-1004.25
2023-1104.35
2023-1204.33
2024-0108.47
2024-0204.54
2024-0305.08
2024-0405.24
2024-0504.59
2024-0604.71
2024-0703.95
2024-0802.72
2024-0903.68
2024-1002.86
2024-1104.1
2024-1204.11
2025-0104.18
2025-0203.71
2025-0304.25
2025-0402.97
2025-0504.84
2025-0604.23
2025-0704.62
2025-0803.85
2025-0905.33
2025-1005.63
2025-1103.9
2025-1206.91
2026-0104.47
2026-0205.24
2026-0305.22
2026-0405.67
2026-0503.84
2026-0605.86
This device (reports/month)Average device in OBJ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K103255 — cites (transitively): K081625 (d1), K093775 (d1) — cited as predicate by K122545, K132133, K200037

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

Manufacturer compliance record — TELEFLEX INCORPORATED

  • NAI 2026-01-15 Teleflex Medical OEM LLC · 0 citations
  • NAI 2024-03-18 Teleflex LLC (NADC) · 0 citations
  • NAI 2024-03-18 Teleflex LLC (NADC) · 0 citations
  • NAI 2024-01-26 Teleflex Medical OEM LLC · 0 citations
  • NAI 2022-12-09 Teleflex Medical de Tecate, S. de R.L de C.V. (A Teleflex Medical Company) · 0 citations
  • VAI 2022-08-26 TELEFLEX LLC · 3 citations
  • VAI 2022-08-26 TELEFLEX LLC · 3 citations
  • NAI 2021-09-02 TELEFLEX LLC · 0 citations
  • NAI 2021-09-02 TELEFLEX LLC · 0 citations
  • VAI 2021-07-30 Teleflex LLC (NADC) · 4 citations
  • NAI 2017-09-21 Teleflex LLC · 0 citations
  • VAI 2017-09-20 Teleflex Medical, Inc. · 1 citations
  • NAI 2017-02-02 Teleflex Medical OEM LLC · 0 citations
  • NAI 2016-08-29 Teleflex Medical OEM LLC · 0 citations
  • NAI 2016-03-03 Teleflex LLC (NADC) · 0 citations
  • NAI 2016-03-03 Teleflex LLC (NADC) · 0 citations
  • NAI 2015-08-13 Teleflex Medical Sdn. Bhd. · 0 citations
  • NAI 2015-06-05 Teleflex Medical Europe Ltd · 0 citations
  • NAI 2015-02-25 Teleflex Medical Europe, Ltd. · 0 citations
  • NAI 2014-08-28 TELEFLEX LLC · 0 citations