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LAP CHOLE /OSU EAST

Model K2848 · APPLIED MEDICAL RESOURCES CORPORATION · DI 20607915136066

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

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 2026-09-13 · 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.

4811152019-01: 0 reports for this device; peer average 4.35/device2019-02: 0 reports for this device; peer average 4.48/device2019-03: 0 reports for this device; peer average 4.44/device2019-04: 0 reports for this device; peer average 4.47/device2019-05: 0 reports for this device; peer average 3.73/device2019-06: 0 reports for this device; peer average 4.46/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 3.48/device2019-10: 0 reports for this device; peer average 4.45/device2019-11: 0 reports for this device; peer average 3.53/device2019-12: 0 reports for this device; peer average 4.04/device2020-01: 0 reports for this device; peer average 4.49/device2020-02: 0 reports for this device; peer average 4.01/device2020-03: 0 reports for this device; peer average 4.04/device2020-04: 0 reports for this device; peer average 4.02/device2020-05: 0 reports for this device; peer average 2.69/device2020-06: 0 reports for this device; peer average 4.17/device2020-07: 0 reports for this device; peer average 3.79/device2020-08: 0 reports for this device; peer average 5.05/device2020-09: 0 reports for this device; peer average 5.33/device2020-10: 0 reports for this device; peer average 5.2/device2020-11: 0 reports for this device; peer average 6.17/device2020-12: 0 reports for this device; peer average 5.03/device2021-01: 0 reports for this device; peer average 5.12/device2021-02: 0 reports for this device; peer average 4.96/device2021-03: 0 reports for this device; peer average 6.11/device2021-04: 0 reports for this device; peer average 5.9/device2021-05: 0 reports for this device; peer average 4.78/device2021-06: 0 reports for this device; peer average 5.51/device2021-07: 0 reports for this device; peer average 4.76/device2021-08: 0 reports for this device; peer average 6/device2021-09: 0 reports for this device; peer average 5.63/device2021-10: 0 reports for this device; peer average 5.11/device2021-11: 0 reports for this device; peer average 4.63/device2021-12: 0 reports for this device; peer average 5.96/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 7.07/device2022-04: 0 reports for this device; peer average 8.43/device2022-05: 0 reports for this device; peer average 6.74/device2022-06: 0 reports for this device; peer average 8.42/device2022-07: 0 reports for this device; peer average 7.59/device2022-08: 0 reports for this device; peer average 7.86/device2022-09: 0 reports for this device; peer average 7.22/device2022-10: 0 reports for this device; peer average 6.83/device2022-11: 0 reports for this device; peer average 7.15/device2022-12: 0 reports for this device; peer average 9.08/device2023-01: 0 reports for this device; peer average 8.37/device2023-02: 0 reports for this device; peer average 6.98/device2023-03: 0 reports for this device; peer average 8.81/device2023-04: 0 reports for this device; peer average 8.05/device2023-05: 0 reports for this device; peer average 7.5/device2023-06: 0 reports for this device; peer average 9.46/device2023-07: 0 reports for this device; peer average 7.98/device2023-08: 0 reports for this device; peer average 7.82/device2023-09: 0 reports for this device; peer average 8.18/device2023-10: 0 reports for this device; peer average 9.19/device2023-11: 0 reports for this device; peer average 9.34/device2023-12: 0 reports for this device; peer average 9.23/device2024-01: 0 reports for this device; peer average 8.23/device2024-02: 0 reports for this device; peer average 9/device2024-03: 0 reports for this device; peer average 8.05/device2024-04: 0 reports for this device; peer average 10.79/device2024-05: 0 reports for this device; peer average 8.84/device2024-06: 0 reports for this device; peer average 10.71/device2024-07: 0 reports for this device; peer average 11.01/device2024-08: 0 reports for this device; peer average 10.53/device2024-09: 0 reports for this device; peer average 11.58/device2024-10: 0 reports for this device; peer average 12.49/device2024-11: 0 reports for this device; peer average 8.48/device2024-12: 0 reports for this device; peer average 9.72/device2025-01: 0 reports for this device; peer average 10.22/device2025-02: 0 reports for this device; peer average 8.45/device2025-03: 0 reports for this device; peer average 10.11/device2025-04: 0 reports for this device; peer average 9.44/device2025-05: 0 reports for this device; peer average 9.01/device2025-06: 0 reports for this device; peer average 8.88/device2025-07: 0 reports for this device; peer average 8.99/device2025-08: 0 reports for this device; peer average 10.39/device2025-09: 0 reports for this device; peer average 8.25/device2025-10: 0 reports for this device; peer average 9.97/device2025-11: 0 reports for this device; peer average 10.41/device2025-12: 0 reports for this device; peer average 15.26/device2026-01: 0 reports for this device; peer average 9.95/device2026-02: 0 reports for this device; peer average 10.63/device2026-03: 0 reports for this device; peer average 13.67/device2026-04: 0 reports for this device; peer average 13.75/device2026-05: 0 reports for this device; peer average 11.55/device2026-06: 0 reports for this device; peer average 9.23/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
2019-0204.48
2019-0304.44
2019-0404.47
2019-0503.73
2019-0604.46
2019-0703.51
2019-0803.63
2019-0903.48
2019-1004.45
2019-1103.53
2019-1204.04
2020-0104.49
2020-0204.01
2020-0304.04
2020-0404.02
2020-0502.69
2020-0604.17
2020-0703.79
2020-0805.05
2020-0905.33
2020-1005.2
2020-1106.17
2020-1205.03
2021-0105.12
2021-0204.96
2021-0306.11
2021-0405.9
2021-0504.78
2021-0605.51
2021-0704.76
2021-0806
2021-0905.63
2021-1005.11
2021-1104.63
2021-1205.96
2022-0106.04
2022-0206.52
2022-0307.07
2022-0408.43
2022-0506.74
2022-0608.42
2022-0707.59
2022-0807.86
2022-0907.22
2022-1006.83
2022-1107.15
2022-1209.08
2023-0108.37
2023-0206.98
2023-0308.81
2023-0408.05
2023-0507.5
2023-0609.46
2023-0707.98
2023-0807.82
2023-0908.18
2023-1009.19
2023-1109.34
2023-1209.23
2024-0108.23
2024-0209
2024-0308.05
2024-04010.79
2024-0508.84
2024-06010.71
2024-07011.01
2024-08010.53
2024-09011.58
2024-10012.49
2024-1108.48
2024-1209.72
2025-01010.22
2025-0208.45
2025-03010.11
2025-0409.44
2025-0509.01
2025-0608.88
2025-0708.99
2025-08010.39
2025-0908.25
2025-1009.97
2025-11010.41
2025-12015.26
2026-0109.95
2026-02010.63
2026-03013.67
2026-04013.75
2026-05011.55
2026-0609.23
This device (reports/month)Average device in BTA, 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