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ACUCISE® PROCEDURAL PACK UNIVERSAL PACK C

Model BK004 · APPLIED MEDICAL RESOURCES CORPORATION · DI 20607915128146

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

EYB — Catheter, Ureteral, Gastro-Urology · Class II · 21 CFR 876.5130

EZB — Stylet For Catheter, Gastro-Urology · Class I · 21 CFR 876.5130

FAD — Stent, Ureteral · Class II · 21 CFR 876.4620

FED — Endoscopic Access Overtube, Gastroenterology-Urology · Class II · 21 CFR 876.1500

KNY — Accessories, Catheter, G-U · Class II · 21 CFR 876.5130

UDILibrary device dossier · generated 2026-09-12 · 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.

12342019-01: 0 reports for this device; peer average 2/device2019-02: 0 reports for this device; peer average 1.96/device2019-03: 0 reports for this device; peer average 1.94/device2019-04: 0 reports for this device; peer average 2.06/device2019-05: 0 reports for this device; peer average 2.15/device2019-06: 0 reports for this device; peer average 2.86/device2019-07: 0 reports for this device; peer average 2.08/device2019-08: 0 reports for this device; peer average 1.91/device2019-09: 0 reports for this device; peer average 1.86/device2019-10: 0 reports for this device; peer average 1.72/device2019-11: 0 reports for this device; peer average 1.55/device2019-12: 0 reports for this device; peer average 1.9/device2020-01: 0 reports for this device; peer average 2.15/device2020-02: 0 reports for this device; peer average 2/device2020-03: 0 reports for this device; peer average 1.92/device2020-04: 0 reports for this device; peer average 3.26/device2020-05: 0 reports for this device; peer average 2/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 2.08/device2020-08: 0 reports for this device; peer average 2.15/device2020-09: 0 reports for this device; peer average 2.32/device2020-10: 0 reports for this device; peer average 2.06/device2020-11: 0 reports for this device; peer average 2.03/device2020-12: 0 reports for this device; peer average 1.97/device2021-01: 0 reports for this device; peer average 1.58/device2021-02: 0 reports for this device; peer average 2.09/device2021-03: 0 reports for this device; peer average 1.41/device2021-04: 0 reports for this device; peer average 1.77/device2021-05: 0 reports for this device; peer average 1.72/device2021-06: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 2.11/device2021-08: 0 reports for this device; peer average 1.79/device2021-09: 0 reports for this device; peer average 2.21/device2021-10: 0 reports for this device; peer average 2.66/device2021-11: 0 reports for this device; peer average 2.61/device2021-12: 0 reports for this device; peer average 1.68/device2022-01: 0 reports for this device; peer average 2.42/device2022-02: 0 reports for this device; peer average 1.81/device2022-03: 0 reports for this device; peer average 2.52/device2022-04: 0 reports for this device; peer average 2.8/device2022-05: 0 reports for this device; peer average 2.26/device2022-06: 0 reports for this device; peer average 2.4/device2022-07: 0 reports for this device; peer average 1.86/device2022-08: 0 reports for this device; peer average 1.98/device2022-09: 0 reports for this device; peer average 2.16/device2022-10: 0 reports for this device; peer average 1.98/device2022-11: 0 reports for this device; peer average 2.29/device2022-12: 0 reports for this device; peer average 2.07/device2023-01: 0 reports for this device; peer average 3.83/device2023-02: 0 reports for this device; peer average 1.96/device2023-03: 0 reports for this device; peer average 2.49/device2023-04: 0 reports for this device; peer average 2.17/device2023-05: 0 reports for this device; peer average 2.21/device2023-06: 0 reports for this device; peer average 2.34/device2023-07: 0 reports for this device; peer average 2.64/device2023-08: 0 reports for this device; peer average 2.1/device2023-09: 0 reports for this device; peer average 2.38/device2023-10: 0 reports for this device; peer average 1.91/device2023-11: 0 reports for this device; peer average 2.19/device2023-12: 0 reports for this device; peer average 2.35/device2024-01: 0 reports for this device; peer average 1.73/device2024-02: 0 reports for this device; peer average 1.98/device2024-03: 0 reports for this device; peer average 1.76/device2024-04: 0 reports for this device; peer average 2.05/device2024-05: 0 reports for this device; peer average 2.03/device2024-06: 0 reports for this device; peer average 1.77/device2024-07: 0 reports for this device; peer average 2.22/device2024-08: 0 reports for this device; peer average 2.22/device2024-09: 0 reports for this device; peer average 2.02/device2024-10: 0 reports for this device; peer average 2.15/device2024-11: 0 reports for this device; peer average 2.3/device2024-12: 0 reports for this device; peer average 2/device2025-01: 0 reports for this device; peer average 2.36/device2025-02: 0 reports for this device; peer average 2.05/device2025-03: 0 reports for this device; peer average 2.51/device2025-04: 0 reports for this device; peer average 2.61/device2025-05: 0 reports for this device; peer average 2.9/device2025-06: 0 reports for this device; peer average 2.57/device2025-07: 0 reports for this device; peer average 2.37/device2025-08: 0 reports for this device; peer average 2.48/device2025-09: 0 reports for this device; peer average 2.46/device2025-10: 0 reports for this device; peer average 2.78/device2025-11: 0 reports for this device; peer average 2.28/device2025-12: 0 reports for this device; peer average 2.58/device2026-01: 0 reports for this device; peer average 3.11/device2026-02: 0 reports for this device; peer average 3.23/device2026-03: 0 reports for this device; peer average 2.55/device2026-04: 0 reports for this device; peer average 2.33/device2026-05: 0 reports for this device; peer average 2.89/device2026-06: 0 reports for this device; peer average 2/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-0201.96
2019-0301.94
2019-0402.06
2019-0502.15
2019-0602.86
2019-0702.08
2019-0801.91
2019-0901.86
2019-1001.72
2019-1101.55
2019-1201.9
2020-0102.15
2020-0202
2020-0301.92
2020-0403.26
2020-0502
2020-0602
2020-0702.08
2020-0802.15
2020-0902.32
2020-1002.06
2020-1102.03
2020-1201.97
2021-0101.58
2021-0202.09
2021-0301.41
2021-0401.77
2021-0501.72
2021-0602
2021-0702.11
2021-0801.79
2021-0902.21
2021-1002.66
2021-1102.61
2021-1201.68
2022-0102.42
2022-0201.81
2022-0302.52
2022-0402.8
2022-0502.26
2022-0602.4
2022-0701.86
2022-0801.98
2022-0902.16
2022-1001.98
2022-1102.29
2022-1202.07
2023-0103.83
2023-0201.96
2023-0302.49
2023-0402.17
2023-0502.21
2023-0602.34
2023-0702.64
2023-0802.1
2023-0902.38
2023-1001.91
2023-1102.19
2023-1202.35
2024-0101.73
2024-0201.98
2024-0301.76
2024-0402.05
2024-0502.03
2024-0601.77
2024-0702.22
2024-0802.22
2024-0902.02
2024-1002.15
2024-1102.3
2024-1202
2025-0102.36
2025-0202.05
2025-0302.51
2025-0402.61
2025-0502.9
2025-0602.57
2025-0702.37
2025-0802.48
2025-0902.46
2025-1002.78
2025-1102.28
2025-1202.58
2026-0103.11
2026-0203.23
2026-0302.55
2026-0402.33
2026-0502.89
2026-0602
This device (reports/month)Average device in DXT, EYB, EZB, FAD, FED, KNY (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — APPLIED MEDICAL RESOURCES CORPORATION

  • Warning Letter 2015-04-10 Applied Medical Resources Corp
  • Warning Letter 2015-04-10 Applied Medical Resources Corp
  • NAI 2021-09-02 Applied Medical Resources Corp · 0 citations
  • NAI 2021-09-02 Applied Medical Resources Corp · 0 citations
  • NAI 2018-11-20 Applied Medical Resources Corp · 0 citations
  • NAI 2018-11-20 Applied Medical Resources Corp · 0 citations
  • VAI 2017-03-31 Applied Medical Resources Corp · 0 citations
  • VAI 2017-03-31 Applied Medical Resources Corp · 0 citations
  • NAI 2015-12-03 Applied Medical Resources Corporation · 0 citations
  • OAI 2015-10-14 Applied Medical Resources Corp · 8 citations
  • OAI 2015-10-14 Applied Medical Resources Corp · 8 citations
  • OAI 2014-12-16 Applied Medical Resources Corp · 8 citations
  • NAI 2014-12-16 Applied Medical Distribution Center · 0 citations
  • OAI 2014-12-16 Applied Medical Resources Corp · 8 citations