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Arcadia™

Model 00884450748978 · Merit Medical Systems, Inc. · DI 00884450748978

HRX — Arthroscope · Class II · 21 CFR 888.1100

HXG — Tamp · Class I · 21 CFR 888.4540

NDN — Cement, Bone, Vertebroplasty · Class II · 21 CFR 888.3027

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.

369122019-01: 0 reports for this device; peer average 12.14/device2019-02: 0 reports for this device; peer average 3.17/device2019-03: 0 reports for this device; peer average 3.71/device2019-04: 0 reports for this device; peer average 3.88/device2019-05: 0 reports for this device; peer average 3.78/device2019-06: 0 reports for this device; peer average 3.47/device2019-07: 0 reports for this device; peer average 3.13/device2019-08: 0 reports for this device; peer average 3.64/device2019-09: 0 reports for this device; peer average 4.22/device2019-10: 0 reports for this device; peer average 4.64/device2019-11: 0 reports for this device; peer average 4.39/device2019-12: 0 reports for this device; peer average 4.84/device2020-01: 0 reports for this device; peer average 4.8/device2020-02: 0 reports for this device; peer average 5.19/device2020-03: 0 reports for this device; peer average 5/device2020-04: 0 reports for this device; peer average 4.82/device2020-05: 0 reports for this device; peer average 3.44/device2020-06: 0 reports for this device; peer average 5.37/device2020-07: 0 reports for this device; peer average 5.23/device2020-08: 0 reports for this device; peer average 5.18/device2020-09: 0 reports for this device; peer average 7.19/device2020-10: 0 reports for this device; peer average 8.02/device2020-11: 0 reports for this device; peer average 5.31/device2020-12: 0 reports for this device; peer average 8.69/device2021-01: 0 reports for this device; peer average 6.03/device2021-02: 0 reports for this device; peer average 5.67/device2021-03: 0 reports for this device; peer average 7.49/device2021-04: 0 reports for this device; peer average 5.83/device2021-05: 0 reports for this device; peer average 5.38/device2021-06: 0 reports for this device; peer average 5.28/device2021-07: 0 reports for this device; peer average 4.33/device2021-08: 0 reports for this device; peer average 5.11/device2021-09: 0 reports for this device; peer average 3.13/device2021-10: 0 reports for this device; peer average 4.62/device2021-11: 0 reports for this device; peer average 3.57/device2021-12: 0 reports for this device; peer average 4.93/device2022-01: 0 reports for this device; peer average 4.43/device2022-02: 0 reports for this device; peer average 3.48/device2022-03: 0 reports for this device; peer average 4.1/device2022-04: 0 reports for this device; peer average 3.87/device2022-05: 0 reports for this device; peer average 3.96/device2022-06: 0 reports for this device; peer average 4.28/device2022-07: 0 reports for this device; peer average 3.92/device2022-08: 0 reports for this device; peer average 3.74/device2022-09: 0 reports for this device; peer average 3.73/device2022-10: 0 reports for this device; peer average 3.89/device2022-11: 0 reports for this device; peer average 4.37/device2022-12: 0 reports for this device; peer average 4.34/device2023-01: 0 reports for this device; peer average 4.65/device2023-02: 0 reports for this device; peer average 4.27/device2023-03: 0 reports for this device; peer average 5.14/device2023-04: 0 reports for this device; peer average 4.4/device2023-05: 0 reports for this device; peer average 4.5/device2023-06: 0 reports for this device; peer average 4.19/device2023-07: 0 reports for this device; peer average 4.17/device2023-08: 0 reports for this device; peer average 4.59/device2023-09: 0 reports for this device; peer average 4.66/device2023-10: 0 reports for this device; peer average 4.2/device2023-11: 0 reports for this device; peer average 7.06/device2023-12: 0 reports for this device; peer average 8.7/device2024-01: 0 reports for this device; peer average 5.68/device2024-02: 0 reports for this device; peer average 6.4/device2024-03: 0 reports for this device; peer average 4.97/device2024-04: 0 reports for this device; peer average 5.54/device2024-05: 0 reports for this device; peer average 8.23/device2024-06: 0 reports for this device; peer average 8.16/device2024-07: 0 reports for this device; peer average 4.65/device2024-08: 0 reports for this device; peer average 4.72/device2024-09: 0 reports for this device; peer average 4.38/device2024-10: 0 reports for this device; peer average 5.66/device2024-11: 0 reports for this device; peer average 4.77/device2024-12: 0 reports for this device; peer average 6.59/device2025-01: 0 reports for this device; peer average 7.81/device2025-02: 0 reports for this device; peer average 5.62/device2025-03: 0 reports for this device; peer average 4.62/device2025-04: 0 reports for this device; peer average 4.71/device2025-05: 0 reports for this device; peer average 5.15/device2025-06: 0 reports for this device; peer average 4.49/device2025-07: 0 reports for this device; peer average 4.28/device2025-08: 0 reports for this device; peer average 4/device2025-09: 0 reports for this device; peer average 4.23/device2025-10: 0 reports for this device; peer average 4.56/device2025-11: 0 reports for this device; peer average 5.45/device2025-12: 0 reports for this device; peer average 5.46/device2026-01: 0 reports for this device; peer average 4.98/device2026-02: 0 reports for this device; peer average 5.41/device2026-03: 0 reports for this device; peer average 4.76/device2026-04: 0 reports for this device; peer average 6.29/device2026-05: 0 reports for this device; peer average 4.15/device2026-06: 0 reports for this device; peer average 4.27/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-01012.14
2019-0203.17
2019-0303.71
2019-0403.88
2019-0503.78
2019-0603.47
2019-0703.13
2019-0803.64
2019-0904.22
2019-1004.64
2019-1104.39
2019-1204.84
2020-0104.8
2020-0205.19
2020-0305
2020-0404.82
2020-0503.44
2020-0605.37
2020-0705.23
2020-0805.18
2020-0907.19
2020-1008.02
2020-1105.31
2020-1208.69
2021-0106.03
2021-0205.67
2021-0307.49
2021-0405.83
2021-0505.38
2021-0605.28
2021-0704.33
2021-0805.11
2021-0903.13
2021-1004.62
2021-1103.57
2021-1204.93
2022-0104.43
2022-0203.48
2022-0304.1
2022-0403.87
2022-0503.96
2022-0604.28
2022-0703.92
2022-0803.74
2022-0903.73
2022-1003.89
2022-1104.37
2022-1204.34
2023-0104.65
2023-0204.27
2023-0305.14
2023-0404.4
2023-0504.5
2023-0604.19
2023-0704.17
2023-0804.59
2023-0904.66
2023-1004.2
2023-1107.06
2023-1208.7
2024-0105.68
2024-0206.4
2024-0304.97
2024-0405.54
2024-0508.23
2024-0608.16
2024-0704.65
2024-0804.72
2024-0904.38
2024-1005.66
2024-1104.77
2024-1206.59
2025-0107.81
2025-0205.62
2025-0304.62
2025-0404.71
2025-0505.15
2025-0604.49
2025-0704.28
2025-0804
2025-0904.23
2025-1004.56
2025-1105.45
2025-1205.46
2026-0104.98
2026-0205.41
2026-0304.76
2026-0406.29
2026-0504.15
2026-0604.27
This device (reports/month)Average device in HRX, HXG, NDN (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Merit Medical Systems, Inc.

  • Warning Letter 2012-01-30 Merit Medical Ireland Ltd.
  • NAI 2025-02-19 KA Medical LLC · 0 citations
  • NAI 2024-11-22 Merit Medical Systems, Inc. · 0 citations
  • NAI 2024-11-22 Merit Medical Systems, Inc. · 0 citations
  • NAI 2023-10-06 Merit Medical Systems, Inc. · 0 citations
  • NAI 2023-10-06 Merit Medical Systems, Inc. · 0 citations
  • NAI 2021-12-10 Merit Medical Systems, Inc. · 0 citations
  • NAI 2021-12-10 Merit Medical Systems, Inc. · 0 citations
  • NAI 2020-03-17 KA Medical LLC · 0 citations
  • VAI 2017-12-07 Merit Medical Systems, Inc. · 1 citations
  • VAI 2017-12-07 Merit Medical Systems, Inc. · 1 citations
  • NAI 2017-03-15 Merit Medical Systems, Inc. · 0 citations
  • NAI 2017-03-15 Merit Medical Systems, Inc. · 0 citations
  • VAI 2016-09-27 Merit Medical Systems, Inc. · 5 citations
  • VAI 2016-09-27 Merit Medical Systems, Inc. · 5 citations
  • VAI 2016-09-09 Cianna Medical, Inc. · 1 citations
  • NAI 2016-06-23 Merit Medical Systems, Inc. · 0 citations
  • NAI 2016-06-23 Merit Medical Systems, Inc. · 0 citations
  • VAI 2016-06-16 BioSphere Medical S.A. · 8 citations
  • NAI 2016-03-22 Merit Medical Systems, Inc. · 0 citations
  • NAI 2016-03-22 Merit Medical Systems, Inc. · 0 citations