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DR. FARROW-LEE KATY SC

Model K2837 · APPLIED MEDICAL RESOURCES CORPORATION · DI 30607915135967

BTA — Pump, Portable, Aspiration (Manual Or Powered) · Class II · 21 CFR 878.4780

FZP — Clip, Implantable · Class II · 21 CFR 878.4300

GCJ — Laparoscope, General & Plastic Surgery · Class II · 21 CFR 876.1500

MDM — Instrument, Manual, Surgical, General Use · Class I · 21 CFR 878.4800

NWV — Laparoscopic Accessories, Gynecologic · Class I · 21 CFR 884.1720

UDILibrary device dossier · generated 2026-09-13 · 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.

24792019-01: 0 reports for this device; peer average 4.36/device2019-02: 0 reports for this device; peer average 4.5/device2019-03: 0 reports for this device; peer average 4.48/device2019-04: 0 reports for this device; peer average 4.52/device2019-05: 0 reports for this device; peer average 3.75/device2019-06: 0 reports for this device; peer average 4.59/device2019-07: 0 reports for this device; peer average 3.53/device2019-08: 0 reports for this device; peer average 3.64/device2019-09: 0 reports for this device; peer average 3.54/device2019-10: 0 reports for this device; peer average 4.54/device2019-11: 0 reports for this device; peer average 3.57/device2019-12: 0 reports for this device; peer average 4.04/device2020-01: 0 reports for this device; peer average 4.6/device2020-02: 0 reports for this device; peer average 4.15/device2020-03: 0 reports for this device; peer average 4.06/device2020-04: 0 reports for this device; peer average 4.01/device2020-05: 0 reports for this device; peer average 2.68/device2020-06: 0 reports for this device; peer average 4.14/device2020-07: 0 reports for this device; peer average 3.71/device2020-08: 0 reports for this device; peer average 4.95/device2020-09: 0 reports for this device; peer average 5.32/device2020-10: 0 reports for this device; peer average 5.1/device2020-11: 0 reports for this device; peer average 5.9/device2020-12: 0 reports for this device; peer average 4.82/device2021-01: 0 reports for this device; peer average 5/device2021-02: 0 reports for this device; peer average 4.89/device2021-03: 0 reports for this device; peer average 5.8/device2021-04: 0 reports for this device; peer average 5.49/device2021-05: 0 reports for this device; peer average 4.34/device2021-06: 0 reports for this device; peer average 5.14/device2021-07: 0 reports for this device; peer average 4.59/device2021-08: 0 reports for this device; peer average 5.78/device2021-09: 0 reports for this device; peer average 5.45/device2021-10: 0 reports for this device; peer average 4.86/device2021-11: 0 reports for this device; peer average 4.49/device2021-12: 0 reports for this device; peer average 5.54/device2022-01: 0 reports for this device; peer average 5.29/device2022-02: 0 reports for this device; peer average 5.28/device2022-03: 0 reports for this device; peer average 5.96/device2022-04: 0 reports for this device; peer average 7.23/device2022-05: 0 reports for this device; peer average 5.74/device2022-06: 0 reports for this device; peer average 7.14/device2022-07: 0 reports for this device; peer average 6.35/device2022-08: 0 reports for this device; peer average 6.76/device2022-09: 0 reports for this device; peer average 6.26/device2022-10: 0 reports for this device; peer average 5.93/device2022-11: 0 reports for this device; peer average 6.15/device2022-12: 0 reports for this device; peer average 7.08/device2023-01: 0 reports for this device; peer average 6.35/device2023-02: 0 reports for this device; peer average 5.86/device2023-03: 0 reports for this device; peer average 6.78/device2023-04: 0 reports for this device; peer average 6.76/device2023-05: 0 reports for this device; peer average 6.18/device2023-06: 0 reports for this device; peer average 8.19/device2023-07: 0 reports for this device; peer average 6.71/device2023-08: 0 reports for this device; peer average 6.59/device2023-09: 0 reports for this device; peer average 6.65/device2023-10: 0 reports for this device; peer average 7.91/device2023-11: 0 reports for this device; peer average 7.99/device2023-12: 0 reports for this device; peer average 8.25/device2024-01: 0 reports for this device; peer average 7.26/device2024-02: 0 reports for this device; peer average 8.27/device2024-03: 0 reports for this device; peer average 6.89/device2024-04: 0 reports for this device; peer average 8.87/device2024-05: 0 reports for this device; peer average 5.71/device2024-06: 0 reports for this device; peer average 6.65/device2024-07: 0 reports for this device; peer average 6.39/device2024-08: 0 reports for this device; peer average 6.7/device2024-09: 0 reports for this device; peer average 7.24/device2024-10: 0 reports for this device; peer average 8.16/device2024-11: 0 reports for this device; peer average 5.95/device2024-12: 0 reports for this device; peer average 5.94/device2025-01: 0 reports for this device; peer average 5.54/device2025-02: 0 reports for this device; peer average 4.53/device2025-03: 0 reports for this device; peer average 6.53/device2025-04: 0 reports for this device; peer average 6.09/device2025-05: 0 reports for this device; peer average 6.07/device2025-06: 0 reports for this device; peer average 6.14/device2025-07: 0 reports for this device; peer average 6.08/device2025-08: 0 reports for this device; peer average 6.77/device2025-09: 0 reports for this device; peer average 5.46/device2025-10: 0 reports for this device; peer average 6.35/device2025-11: 0 reports for this device; peer average 5.88/device2025-12: 0 reports for this device; peer average 8.5/device2026-01: 0 reports for this device; peer average 6.46/device2026-02: 0 reports for this device; peer average 6.74/device2026-03: 0 reports for this device; peer average 7.55/device2026-04: 0 reports for this device; peer average 8.28/device2026-05: 0 reports for this device; peer average 6.62/device2026-06: 0 reports for this device; peer average 6/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104.36
2019-0204.5
2019-0304.48
2019-0404.52
2019-0503.75
2019-0604.59
2019-0703.53
2019-0803.64
2019-0903.54
2019-1004.54
2019-1103.57
2019-1204.04
2020-0104.6
2020-0204.15
2020-0304.06
2020-0404.01
2020-0502.68
2020-0604.14
2020-0703.71
2020-0804.95
2020-0905.32
2020-1005.1
2020-1105.9
2020-1204.82
2021-0105
2021-0204.89
2021-0305.8
2021-0405.49
2021-0504.34
2021-0605.14
2021-0704.59
2021-0805.78
2021-0905.45
2021-1004.86
2021-1104.49
2021-1205.54
2022-0105.29
2022-0205.28
2022-0305.96
2022-0407.23
2022-0505.74
2022-0607.14
2022-0706.35
2022-0806.76
2022-0906.26
2022-1005.93
2022-1106.15
2022-1207.08
2023-0106.35
2023-0205.86
2023-0306.78
2023-0406.76
2023-0506.18
2023-0608.19
2023-0706.71
2023-0806.59
2023-0906.65
2023-1007.91
2023-1107.99
2023-1208.25
2024-0107.26
2024-0208.27
2024-0306.89
2024-0408.87
2024-0505.71
2024-0606.65
2024-0706.39
2024-0806.7
2024-0907.24
2024-1008.16
2024-1105.95
2024-1205.94
2025-0105.54
2025-0204.53
2025-0306.53
2025-0406.09
2025-0506.07
2025-0606.14
2025-0706.08
2025-0806.77
2025-0905.46
2025-1006.35
2025-1105.88
2025-1208.5
2026-0106.46
2026-0206.74
2026-0307.55
2026-0408.28
2026-0506.62
2026-0606
This device (reports/month)Average device in BTA, FZP, GCJ, MDM, NWV (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