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AED ENDOPRO® PRIMO SERIES CAMERA

Model EP2050HD · NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · DI 00848657077088

FWF — Camera, Television, Endoscopic, Without Audio · Class I · 21 CFR 878.4160

KQM — Camera, Surgical And Accessories · Class I · 21 CFR 878.4160

UDILibrary device dossier · generated 2026-09-07 · 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.

152944592019-01: 0 reports for this device; peer average 5/device2019-02: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 2.5/device2019-04: 0 reports for this device; peer average 1.33/device2019-05: 0 reports for this device; peer average 3.5/device2019-06: 0 reports for this device; peer average 3/device2019-07: 0 reports for this device; peer average 2/device2019-08: 0 reports for this device; peer average 3/device2019-09: 0 reports for this device; peer average 3/device2019-10: 0 reports for this device; peer average 7/device2019-11: 0 reports for this device; peer average 3.5/device2019-12: 0 reports for this device; peer average 2/device2020-01: 0 reports for this device; peer average 2.75/device2020-02: 0 reports for this device; peer average 6/device2020-03: 0 reports for this device; peer average 5/device2020-04: 0 reports for this device; peer average 3/device2020-05: 0 reports for this device; peer average 4/device2020-06: 0 reports for this device; peer average 7/device2020-07: 0 reports for this device; peer average 9.33/device2020-08: 0 reports for this device; peer average 4/device2020-09: 0 reports for this device; peer average 5.25/device2020-10: 0 reports for this device; peer average 3.25/device2020-11: 0 reports for this device; peer average 5.67/device2020-12: 0 reports for this device; peer average 4.5/device2021-01: 0 reports for this device; peer average 3.5/device2021-02: 0 reports for this device; peer average 6/device2021-03: 0 reports for this device; peer average 3.5/device2021-04: 0 reports for this device; peer average 5.5/device2021-05: 0 reports for this device; peer average 4/device2021-06: 0 reports for this device; peer average 4.33/device2021-07: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 1.67/device2021-09: 0 reports for this device; peer average 3.67/device2021-10: 0 reports for this device; peer average 4.33/device2021-11: 0 reports for this device; peer average 6/device2021-12: 0 reports for this device; peer average 2.5/device2022-01: 0 reports for this device; peer average 4/device2022-02: 0 reports for this device; peer average 6/device2022-03: 0 reports for this device; peer average 3.5/device2022-04: 0 reports for this device; peer average 5.5/device2022-05: 0 reports for this device; peer average 6.5/device2022-06: 0 reports for this device; peer average 4.33/device2022-07: 0 reports for this device; peer average 4.5/device2022-08: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 3.33/device2022-10: 0 reports for this device; peer average 4/device2022-11: 0 reports for this device; peer average 3.67/device2022-12: 0 reports for this device; peer average 5/device2023-01: 0 reports for this device; peer average 2.5/device2023-02: 0 reports for this device; peer average 2.5/device2023-03: 0 reports for this device; peer average 4.67/device2023-04: 0 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 2/device2023-06: 0 reports for this device; peer average 2/device2023-07: 0 reports for this device; peer average 2.75/device2023-08: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 3.5/device2023-10: 0 reports for this device; peer average 2.5/device2023-11: 0 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 4.5/device2024-01: 0 reports for this device; peer average 1.67/device2024-02: 0 reports for this device; peer average 2.33/device2024-03: 0 reports for this device; peer average 1.8/device2024-04: 0 reports for this device; peer average 3/device2024-05: 0 reports for this device; peer average 3/device2024-06: 0 reports for this device; peer average 4.33/device2024-07: 0 reports for this device; peer average 2.25/device2024-08: 0 reports for this device; peer average 1.5/device2024-09: 0 reports for this device; peer average 5/device2024-10: 0 reports for this device; peer average 2.33/device2024-11: 0 reports for this device; peer average 1.75/device2024-12: 0 reports for this device; peer average 2/device2025-01: 0 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 3/device2025-05: 0 reports for this device; peer average 14/device2025-06: 0 reports for this device; peer average 3/device2025-07: 0 reports for this device; peer average 2.5/device2025-08: 0 reports for this device; peer average 2.5/device2025-09: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 3/device2025-11: 0 reports for this device; peer average 2.67/device2025-12: 0 reports for this device; peer average 2.5/device2026-01: 0 reports for this device; peer average 8.29/device2026-02: 0 reports for this device; peer average 12/device2026-03: 0 reports for this device; peer average 14.13/device2026-04: 0 reports for this device; peer average 17.57/device2026-05: 0 reports for this device; peer average 7.67/device2026-06: 0 reports for this device; peer average 58.76/device0102030405060708091011120102030405060708091011120102030405060708091011120102030405060708091011120102030405060708091011120102030405060708091011120102040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0105
2019-0201
2019-0302.5
2019-0401.33
2019-0503.5
2019-0603
2019-0702
2019-0803
2019-0903
2019-1007
2019-1103.5
2019-1202
2020-0102.75
2020-0206
2020-0305
2020-0403
2020-0504
2020-0607
2020-0709.33
2020-0804
2020-0905.25
2020-1003.25
2020-1105.67
2020-1204.5
2021-0103.5
2021-0206
2021-0303.5
2021-0405.5
2021-0504
2021-0604.33
2021-0702
2021-0801.67
2021-0903.67
2021-1004.33
2021-1106
2021-1202.5
2022-0104
2022-0206
2022-0303.5
2022-0405.5
2022-0506.5
2022-0604.33
2022-0704.5
2022-0801
2022-0903.33
2022-1004
2022-1103.67
2022-1205
2023-0102.5
2023-0202.5
2023-0304.67
2023-0402
2023-0502
2023-0602
2023-0702.75
2023-0801
2023-0903.5
2023-1002.5
2023-1101
2023-1204.5
2024-0101.67
2024-0202.33
2024-0301.8
2024-0403
2024-0503
2024-0604.33
2024-0702.25
2024-0801.5
2024-0905
2024-1002.33
2024-1101.75
2024-1202
2025-0102
2025-0202
2025-0403
2025-05014
2025-0603
2025-0702.5
2025-0802.5
2025-0902
2025-1003
2025-1102.67
2025-1202.5
2026-0108.29
2026-02012
2026-03014.13
2026-04017.57
2026-0507.67
2026-06058.76
This device (reports/month)Average device in FWF, KQM (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

  • VAI 2024-01-12 National Advanced Endoscopy Devices Inc · 0 citations
  • VAI 2024-01-12 National Advanced Endoscopy Devices Inc · 0 citations
  • VAI 2020-09-03 National Advanced Endoscopy Devices Inc · 1 citations
  • VAI 2020-09-03 National Advanced Endoscopy Devices Inc · 1 citations
  • VAI 2019-08-30 National Advanced Endoscopy Devices Inc · 1 citations
  • VAI 2019-08-30 National Advanced Endoscopy Devices Inc · 1 citations
  • VAI 2015-10-26 National Advanced Endoscopy Devices Inc · 3 citations
  • VAI 2015-10-26 National Advanced Endoscopy Devices Inc · 3 citations
  • NAI 2012-07-17 National Advanced Endoscopy Devices Inc · 0 citations
  • NAI 2012-07-17 National Advanced Endoscopy Devices Inc · 0 citations