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DR. TENEWITZ / DR. FASWASZ

Model K2633 · APPLIED MEDICAL RESOURCES CORPORATION · DI 30607915133406

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

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

GEI — Electrosurgical, Cutting & Coagulation & Accessories · Class II · 21 CFR 878.4400

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 2026-09-15 · 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.

358112019-01: 0 reports for this device; peer average 5.78/device2019-02: 0 reports for this device; peer average 4.41/device2019-03: 0 reports for this device; peer average 4.44/device2019-04: 0 reports for this device; peer average 5.4/device2019-05: 0 reports for this device; peer average 4.39/device2019-06: 0 reports for this device; peer average 4.79/device2019-07: 0 reports for this device; peer average 4.83/device2019-08: 0 reports for this device; peer average 5.03/device2019-09: 0 reports for this device; peer average 4.35/device2019-10: 0 reports for this device; peer average 5.31/device2019-11: 0 reports for this device; peer average 4.61/device2019-12: 0 reports for this device; peer average 4.83/device2020-01: 0 reports for this device; peer average 4.69/device2020-02: 0 reports for this device; peer average 4.87/device2020-03: 0 reports for this device; peer average 4.98/device2020-04: 0 reports for this device; peer average 3.79/device2020-05: 0 reports for this device; peer average 3.32/device2020-06: 0 reports for this device; peer average 4.67/device2020-07: 0 reports for this device; peer average 5.13/device2020-08: 0 reports for this device; peer average 4.82/device2020-09: 0 reports for this device; peer average 5.65/device2020-10: 0 reports for this device; peer average 5.4/device2020-11: 0 reports for this device; peer average 5.55/device2020-12: 0 reports for this device; peer average 5.19/device2021-01: 0 reports for this device; peer average 5.16/device2021-02: 0 reports for this device; peer average 4.92/device2021-03: 0 reports for this device; peer average 5.89/device2021-04: 0 reports for this device; peer average 5.56/device2021-05: 0 reports for this device; peer average 4.97/device2021-06: 0 reports for this device; peer average 5.68/device2021-07: 0 reports for this device; peer average 4.83/device2021-08: 0 reports for this device; peer average 5.09/device2021-09: 0 reports for this device; peer average 5.05/device2021-10: 0 reports for this device; peer average 5.52/device2021-11: 0 reports for this device; peer average 4.97/device2021-12: 0 reports for this device; peer average 5.73/device2022-01: 0 reports for this device; peer average 5.57/device2022-02: 0 reports for this device; peer average 5.82/device2022-03: 0 reports for this device; peer average 6.4/device2022-04: 0 reports for this device; peer average 6.58/device2022-05: 0 reports for this device; peer average 6.27/device2022-06: 0 reports for this device; peer average 7.35/device2022-07: 0 reports for this device; peer average 6.05/device2022-08: 0 reports for this device; peer average 6.16/device2022-09: 0 reports for this device; peer average 6.04/device2022-10: 0 reports for this device; peer average 5.88/device2022-11: 0 reports for this device; peer average 5.85/device2022-12: 0 reports for this device; peer average 6.68/device2023-01: 0 reports for this device; peer average 6.93/device2023-02: 0 reports for this device; peer average 5.56/device2023-03: 0 reports for this device; peer average 6.63/device2023-04: 0 reports for this device; peer average 6.4/device2023-05: 0 reports for this device; peer average 6.34/device2023-06: 0 reports for this device; peer average 7.17/device2023-07: 0 reports for this device; peer average 6.35/device2023-08: 0 reports for this device; peer average 6.22/device2023-09: 0 reports for this device; peer average 6.8/device2023-10: 0 reports for this device; peer average 7.22/device2023-11: 0 reports for this device; peer average 6.96/device2023-12: 0 reports for this device; peer average 7.2/device2024-01: 0 reports for this device; peer average 6.88/device2024-02: 0 reports for this device; peer average 7.15/device2024-03: 0 reports for this device; peer average 7.09/device2024-04: 0 reports for this device; peer average 8.45/device2024-05: 0 reports for this device; peer average 7.76/device2024-06: 0 reports for this device; peer average 8.45/device2024-07: 0 reports for this device; peer average 8.19/device2024-08: 0 reports for this device; peer average 7.87/device2024-09: 0 reports for this device; peer average 8.45/device2024-10: 0 reports for this device; peer average 9.27/device2024-11: 0 reports for this device; peer average 6.9/device2024-12: 0 reports for this device; peer average 7.05/device2025-01: 0 reports for this device; peer average 7.93/device2025-02: 0 reports for this device; peer average 6.5/device2025-03: 0 reports for this device; peer average 8.24/device2025-04: 0 reports for this device; peer average 6.82/device2025-05: 0 reports for this device; peer average 7.22/device2025-06: 0 reports for this device; peer average 6.83/device2025-07: 0 reports for this device; peer average 7.03/device2025-08: 0 reports for this device; peer average 8.04/device2025-09: 0 reports for this device; peer average 6.62/device2025-10: 0 reports for this device; peer average 7.61/device2025-11: 0 reports for this device; peer average 8.25/device2025-12: 0 reports for this device; peer average 10.72/device2026-01: 0 reports for this device; peer average 8.16/device2026-02: 0 reports for this device; peer average 8.44/device2026-03: 0 reports for this device; peer average 10.02/device2026-04: 0 reports for this device; peer average 9.98/device2026-05: 0 reports for this device; peer average 9.13/device2026-06: 0 reports for this device; peer average 7.36/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0105.78
2019-0204.41
2019-0304.44
2019-0405.4
2019-0504.39
2019-0604.79
2019-0704.83
2019-0805.03
2019-0904.35
2019-1005.31
2019-1104.61
2019-1204.83
2020-0104.69
2020-0204.87
2020-0304.98
2020-0403.79
2020-0503.32
2020-0604.67
2020-0705.13
2020-0804.82
2020-0905.65
2020-1005.4
2020-1105.55
2020-1205.19
2021-0105.16
2021-0204.92
2021-0305.89
2021-0405.56
2021-0504.97
2021-0605.68
2021-0704.83
2021-0805.09
2021-0905.05
2021-1005.52
2021-1104.97
2021-1205.73
2022-0105.57
2022-0205.82
2022-0306.4
2022-0406.58
2022-0506.27
2022-0607.35
2022-0706.05
2022-0806.16
2022-0906.04
2022-1005.88
2022-1105.85
2022-1206.68
2023-0106.93
2023-0205.56
2023-0306.63
2023-0406.4
2023-0506.34
2023-0607.17
2023-0706.35
2023-0806.22
2023-0906.8
2023-1007.22
2023-1106.96
2023-1207.2
2024-0106.88
2024-0207.15
2024-0307.09
2024-0408.45
2024-0507.76
2024-0608.45
2024-0708.19
2024-0807.87
2024-0908.45
2024-1009.27
2024-1106.9
2024-1207.05
2025-0107.93
2025-0206.5
2025-0308.24
2025-0406.82
2025-0507.22
2025-0606.83
2025-0707.03
2025-0808.04
2025-0906.62
2025-1007.61
2025-1108.25
2025-12010.72
2026-0108.16
2026-0208.44
2026-03010.02
2026-0409.98
2026-0509.13
2026-0607.36
This device (reports/month)Average device in FZP, GCJ, GEI, 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