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"12"" II Tube Drape (36X36)"

Model 5258497 · ADVANCE MEDICAL DESIGNS, INC. · DI 00848340010309

JAA — System, X-Ray, Fluoroscopic, Image-Intensified · Class II · 21 CFR 892.1650

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.

39781171562019-01: 0 reports for this device; peer average 4.17/device2019-02: 0 reports for this device; peer average 3.3/device2019-03: 0 reports for this device; peer average 4.29/device2019-04: 0 reports for this device; peer average 8/device2019-05: 0 reports for this device; peer average 3.29/device2019-06: 0 reports for this device; peer average 2.63/device2019-07: 0 reports for this device; peer average 3.67/device2019-08: 0 reports for this device; peer average 2.2/device2019-09: 0 reports for this device; peer average 2.43/device2019-10: 0 reports for this device; peer average 2.23/device2019-11: 0 reports for this device; peer average 1.38/device2019-12: 0 reports for this device; peer average 2.8/device2020-01: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 3.13/device2020-03: 0 reports for this device; peer average 1.33/device2020-04: 0 reports for this device; peer average 2/device2020-05: 0 reports for this device; peer average 1.67/device2020-06: 0 reports for this device; peer average 2.29/device2020-07: 0 reports for this device; peer average 2.3/device2020-08: 0 reports for this device; peer average 1.44/device2020-09: 0 reports for this device; peer average 2.33/device2020-10: 0 reports for this device; peer average 2.31/device2020-11: 0 reports for this device; peer average 2.12/device2020-12: 0 reports for this device; peer average 2.11/device2021-01: 0 reports for this device; peer average 1.56/device2021-02: 0 reports for this device; peer average 2.44/device2021-03: 0 reports for this device; peer average 2.2/device2021-04: 0 reports for this device; peer average 3.8/device2021-05: 0 reports for this device; peer average 4.2/device2021-06: 0 reports for this device; peer average 5.71/device2021-07: 0 reports for this device; peer average 2.74/device2021-08: 0 reports for this device; peer average 8.12/device2021-09: 0 reports for this device; peer average 9.38/device2021-10: 0 reports for this device; peer average 7.07/device2021-11: 0 reports for this device; peer average 8.79/device2021-12: 0 reports for this device; peer average 7.23/device2022-01: 0 reports for this device; peer average 6.63/device2022-02: 0 reports for this device; peer average 6.38/device2022-03: 0 reports for this device; peer average 7.58/device2022-04: 0 reports for this device; peer average 6.07/device2022-05: 0 reports for this device; peer average 9.57/device2022-06: 0 reports for this device; peer average 6.89/device2022-07: 0 reports for this device; peer average 5.79/device2022-08: 0 reports for this device; peer average 7.65/device2022-09: 0 reports for this device; peer average 7.29/device2022-10: 0 reports for this device; peer average 20.38/device2022-11: 0 reports for this device; peer average 37.58/device2022-12: 0 reports for this device; peer average 37.27/device2023-01: 0 reports for this device; peer average 47.41/device2023-02: 0 reports for this device; peer average 32.29/device2023-03: 0 reports for this device; peer average 58.3/device2023-04: 0 reports for this device; peer average 36.45/device2023-05: 0 reports for this device; peer average 41.02/device2023-06: 0 reports for this device; peer average 33.3/device2023-07: 0 reports for this device; peer average 23.74/device2023-08: 0 reports for this device; peer average 28.62/device2023-09: 0 reports for this device; peer average 40.28/device2023-10: 0 reports for this device; peer average 34.58/device2023-11: 0 reports for this device; peer average 40.35/device2023-12: 0 reports for this device; peer average 43.35/device2024-01: 0 reports for this device; peer average 35.68/device2024-02: 0 reports for this device; peer average 53.38/device2024-03: 0 reports for this device; peer average 33.55/device2024-04: 0 reports for this device; peer average 33.08/device2024-05: 0 reports for this device; peer average 40.32/device2024-06: 0 reports for this device; peer average 32.62/device2024-07: 0 reports for this device; peer average 34.95/device2024-08: 0 reports for this device; peer average 46.15/device2024-09: 0 reports for this device; peer average 51.58/device2024-10: 0 reports for this device; peer average 44.14/device2024-11: 0 reports for this device; peer average 41.81/device2024-12: 0 reports for this device; peer average 44.54/device2025-01: 0 reports for this device; peer average 44.17/device2025-02: 0 reports for this device; peer average 54/device2025-03: 0 reports for this device; peer average 46.24/device2025-04: 0 reports for this device; peer average 55.11/device2025-05: 0 reports for this device; peer average 66.14/device2025-06: 0 reports for this device; peer average 58.91/device2025-07: 0 reports for this device; peer average 65.18/device2025-08: 0 reports for this device; peer average 80.44/device2025-09: 0 reports for this device; peer average 156.32/device2025-10: 0 reports for this device; peer average 129.33/device2025-11: 0 reports for this device; peer average 92.22/device2025-12: 0 reports for this device; peer average 41.77/device2026-01: 0 reports for this device; peer average 37.97/device2026-02: 0 reports for this device; peer average 27.53/device2026-03: 0 reports for this device; peer average 30.19/device2026-04: 0 reports for this device; peer average 28.28/device2026-05: 0 reports for this device; peer average 30.3/device2026-06: 0 reports for this device; peer average 23.49/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104.17
2019-0203.3
2019-0304.29
2019-0408
2019-0503.29
2019-0602.63
2019-0703.67
2019-0802.2
2019-0902.43
2019-1002.23
2019-1101.38
2019-1202.8
2020-0102
2020-0203.13
2020-0301.33
2020-0402
2020-0501.67
2020-0602.29
2020-0702.3
2020-0801.44
2020-0902.33
2020-1002.31
2020-1102.12
2020-1202.11
2021-0101.56
2021-0202.44
2021-0302.2
2021-0403.8
2021-0504.2
2021-0605.71
2021-0702.74
2021-0808.12
2021-0909.38
2021-1007.07
2021-1108.79
2021-1207.23
2022-0106.63
2022-0206.38
2022-0307.58
2022-0406.07
2022-0509.57
2022-0606.89
2022-0705.79
2022-0807.65
2022-0907.29
2022-10020.38
2022-11037.58
2022-12037.27
2023-01047.41
2023-02032.29
2023-03058.3
2023-04036.45
2023-05041.02
2023-06033.3
2023-07023.74
2023-08028.62
2023-09040.28
2023-10034.58
2023-11040.35
2023-12043.35
2024-01035.68
2024-02053.38
2024-03033.55
2024-04033.08
2024-05040.32
2024-06032.62
2024-07034.95
2024-08046.15
2024-09051.58
2024-10044.14
2024-11041.81
2024-12044.54
2025-01044.17
2025-02054
2025-03046.24
2025-04055.11
2025-05066.14
2025-06058.91
2025-07065.18
2025-08080.44
2025-090156.32
2025-100129.33
2025-11092.22
2025-12041.77
2026-01037.97
2026-02027.53
2026-03030.19
2026-04028.28
2026-05030.3
2026-06023.49
This device (reports/month)Average device in JAA (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — ADVANCE MEDICAL DESIGNS, INC.

  • VAI 2023-06-30 Advance Medical Designs, Inc. · 4 citations
  • VAI 2023-06-30 Advance Medical Designs, Inc. · 4 citations
  • NAI 2018-07-26 Advance Medical Designs, Inc. · 0 citations
  • NAI 2018-07-26 Advance Medical Designs, Inc. · 0 citations
  • NAI 2016-12-15 Advance Medical Designs, Inc. · 0 citations
  • NAI 2016-12-15 Advance Medical Designs, Inc. · 0 citations
  • NAI 2014-01-15 Advance Medical Designs, Inc. · 0 citations
  • NAI 2014-01-15 Advance Medical Designs, Inc. · 0 citations
  • NAI 2010-06-16 Advance Medical Designs, Inc. · 0 citations
  • NAI 2010-06-16 Advance Medical Designs, Inc. · 0 citations