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PARTNERS LC KIT 006

Model K2421 · APPLIED MEDICAL RESOURCES CORPORATION · DI 30607915131563

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

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

HET — Laparoscope, Gynecologic (And Accessories) · Class II · 21 CFR 884.1720

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

UDILibrary device dossier · generated 2026-09-06 · 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.

4812152019-01: 0 reports for this device; peer average 4.35/device2019-02: 0 reports for this device; peer average 4.49/device2019-03: 0 reports for this device; peer average 4.46/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 4.48/device2019-07: 0 reports for this device; peer average 3.51/device2019-08: 0 reports for this device; peer average 3.63/device2019-09: 0 reports for this device; peer average 3.51/device2019-10: 0 reports for this device; peer average 4.49/device2019-11: 0 reports for this device; peer average 3.36/device2019-12: 0 reports for this device; peer average 4.09/device2020-01: 0 reports for this device; peer average 4.53/device2020-02: 0 reports for this device; peer average 4.08/device2020-03: 0 reports for this device; peer average 4.11/device2020-04: 0 reports for this device; peer average 4.07/device2020-05: 0 reports for this device; peer average 2.72/device2020-06: 0 reports for this device; peer average 4.17/device2020-07: 0 reports for this device; peer average 3.8/device2020-08: 0 reports for this device; peer average 5.07/device2020-09: 0 reports for this device; peer average 5.36/device2020-10: 0 reports for this device; peer average 5.2/device2020-11: 0 reports for this device; peer average 6.19/device2020-12: 0 reports for this device; peer average 5.04/device2021-01: 0 reports for this device; peer average 5.15/device2021-02: 0 reports for this device; peer average 4.96/device2021-03: 0 reports for this device; peer average 6.13/device2021-04: 0 reports for this device; peer average 5.9/device2021-05: 0 reports for this device; peer average 4.79/device2021-06: 0 reports for this device; peer average 5.52/device2021-07: 0 reports for this device; peer average 4.77/device2021-08: 0 reports for this device; peer average 5.87/device2021-09: 0 reports for this device; peer average 5.36/device2021-10: 0 reports for this device; peer average 4.92/device2021-11: 0 reports for this device; peer average 4.55/device2021-12: 0 reports for this device; peer average 5.88/device2022-01: 0 reports for this device; peer average 6.04/device2022-02: 0 reports for this device; peer average 6.52/device2022-03: 0 reports for this device; peer average 6.96/device2022-04: 0 reports for this device; peer average 8.24/device2022-05: 0 reports for this device; peer average 6.74/device2022-06: 0 reports for this device; peer average 8.46/device2022-07: 0 reports for this device; peer average 7.66/device2022-08: 0 reports for this device; peer average 7.85/device2022-09: 0 reports for this device; peer average 7.13/device2022-10: 0 reports for this device; peer average 6.87/device2022-11: 0 reports for this device; peer average 6.98/device2022-12: 0 reports for this device; peer average 9.12/device2023-01: 0 reports for this device; peer average 8.28/device2023-02: 0 reports for this device; peer average 6.52/device2023-03: 0 reports for this device; peer average 8.38/device2023-04: 0 reports for this device; peer average 7.78/device2023-05: 0 reports for this device; peer average 7.35/device2023-06: 0 reports for this device; peer average 9.43/device2023-07: 0 reports for this device; peer average 8.02/device2023-08: 0 reports for this device; peer average 7.68/device2023-09: 0 reports for this device; peer average 8.22/device2023-10: 0 reports for this device; peer average 9.18/device2023-11: 0 reports for this device; peer average 9.23/device2023-12: 0 reports for this device; peer average 9.36/device2024-01: 0 reports for this device; peer average 8.22/device2024-02: 0 reports for this device; peer average 8.73/device2024-03: 0 reports for this device; peer average 7.99/device2024-04: 0 reports for this device; peer average 10.77/device2024-05: 0 reports for this device; peer average 8.71/device2024-06: 0 reports for this device; peer average 10.73/device2024-07: 0 reports for this device; peer average 11/device2024-08: 0 reports for this device; peer average 10.6/device2024-09: 0 reports for this device; peer average 11.5/device2024-10: 0 reports for this device; peer average 12.32/device2024-11: 0 reports for this device; peer average 8.32/device2024-12: 0 reports for this device; peer average 9.82/device2025-01: 0 reports for this device; peer average 10.22/device2025-02: 0 reports for this device; peer average 8.56/device2025-03: 0 reports for this device; peer average 10.23/device2025-04: 0 reports for this device; peer average 9.49/device2025-05: 0 reports for this device; peer average 9.11/device2025-06: 0 reports for this device; peer average 8.81/device2025-07: 0 reports for this device; peer average 8.93/device2025-08: 0 reports for this device; peer average 10.58/device2025-09: 0 reports for this device; peer average 8.44/device2025-10: 0 reports for this device; peer average 10.07/device2025-11: 0 reports for this device; peer average 10.51/device2025-12: 0 reports for this device; peer average 15.45/device2026-01: 0 reports for this device; peer average 10.1/device2026-02: 0 reports for this device; peer average 10.81/device2026-03: 0 reports for this device; peer average 13.74/device2026-04: 0 reports for this device; peer average 13.89/device2026-05: 0 reports for this device; peer average 11.76/device2026-06: 0 reports for this device; peer average 9.35/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104.35
2019-0204.49
2019-0304.46
2019-0404.52
2019-0503.75
2019-0604.48
2019-0703.51
2019-0803.63
2019-0903.51
2019-1004.49
2019-1103.36
2019-1204.09
2020-0104.53
2020-0204.08
2020-0304.11
2020-0404.07
2020-0502.72
2020-0604.17
2020-0703.8
2020-0805.07
2020-0905.36
2020-1005.2
2020-1106.19
2020-1205.04
2021-0105.15
2021-0204.96
2021-0306.13
2021-0405.9
2021-0504.79
2021-0605.52
2021-0704.77
2021-0805.87
2021-0905.36
2021-1004.92
2021-1104.55
2021-1205.88
2022-0106.04
2022-0206.52
2022-0306.96
2022-0408.24
2022-0506.74
2022-0608.46
2022-0707.66
2022-0807.85
2022-0907.13
2022-1006.87
2022-1106.98
2022-1209.12
2023-0108.28
2023-0206.52
2023-0308.38
2023-0407.78
2023-0507.35
2023-0609.43
2023-0708.02
2023-0807.68
2023-0908.22
2023-1009.18
2023-1109.23
2023-1209.36
2024-0108.22
2024-0208.73
2024-0307.99
2024-04010.77
2024-0508.71
2024-06010.73
2024-07011
2024-08010.6
2024-09011.5
2024-10012.32
2024-1108.32
2024-1209.82
2025-01010.22
2025-0208.56
2025-03010.23
2025-0409.49
2025-0509.11
2025-0608.81
2025-0708.93
2025-08010.58
2025-0908.44
2025-10010.07
2025-11010.51
2025-12015.45
2026-01010.1
2026-02010.81
2026-03013.74
2026-04013.89
2026-05011.76
2026-0609.35
This device (reports/month)Average device in FZP, GCJ, HET, MDM (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