Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

AED 35MM Optical Coupler

Model CPL 35 · NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · DI 00848657070935

FEM — Accessories, Photographic, For Endoscope (Exclude Light Sources) · Class I · 21 CFR 876.1500

UDILibrary device dossier · generated 2026-09-11 · 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.

369122019-06: 0 reports for this device; peer average 3/device2019-08: 0 reports for this device; peer average 3/device2020-01: 0 reports for this device; peer average 6/device2020-02: 0 reports for this device; peer average 3/device2020-03: 0 reports for this device; peer average 3/device2020-07: 0 reports for this device; peer average 4/device2020-08: 0 reports for this device; peer average 4.5/device2020-09: 0 reports for this device; peer average 3/device2020-10: 0 reports for this device; peer average 3.5/device2020-11: 0 reports for this device; peer average 2/device2020-12: 0 reports for this device; peer average 3/device2021-01: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 2/device2021-03: 0 reports for this device; peer average 2.5/device2021-04: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 1/device2021-07: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 2/device2021-11: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 3.5/device2022-01: 0 reports for this device; peer average 3.5/device2022-03: 0 reports for this device; peer average 2.5/device2022-05: 0 reports for this device; peer average 2.33/device2022-06: 0 reports for this device; peer average 2/device2022-07: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 2/device2022-09: 0 reports for this device; peer average 4/device2022-10: 0 reports for this device; peer average 7/device2022-11: 0 reports for this device; peer average 2.5/device2022-12: 0 reports for this device; peer average 4/device2023-01: 0 reports for this device; peer average 4.25/device2023-02: 0 reports for this device; peer average 5.67/device2023-03: 0 reports for this device; peer average 6/device2023-04: 0 reports for this device; peer average 7/device2023-05: 0 reports for this device; peer average 3/device2023-06: 0 reports for this device; peer average 3/device2023-07: 0 reports for this device; peer average 5/device2023-08: 0 reports for this device; peer average 10/device2023-09: 0 reports for this device; peer average 4.5/device2023-10: 0 reports for this device; peer average 2.75/device2023-11: 0 reports for this device; peer average 5.5/device2023-12: 0 reports for this device; peer average 5/device2024-01: 0 reports for this device; peer average 2.33/device2024-02: 0 reports for this device; peer average 5/device2024-03: 0 reports for this device; peer average 2.67/device2024-04: 0 reports for this device; peer average 2.75/device2024-05: 0 reports for this device; peer average 1.5/device2024-06: 0 reports for this device; peer average 3/device2024-07: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 3.5/device2024-09: 0 reports for this device; peer average 1.75/device2024-10: 0 reports for this device; peer average 2.25/device2024-11: 0 reports for this device; peer average 7/device2024-12: 0 reports for this device; peer average 8/device2025-01: 0 reports for this device; peer average 1/device2025-02: 0 reports for this device; peer average 6/device2025-03: 0 reports for this device; peer average 1/device2025-04: 0 reports for this device; peer average 4.5/device2025-05: 0 reports for this device; peer average 4/device2025-06: 0 reports for this device; peer average 5.5/device2025-07: 0 reports for this device; peer average 12/device2025-08: 0 reports for this device; peer average 2/device2025-09: 0 reports for this device; peer average 5/device2025-10: 0 reports for this device; peer average 4.5/device2025-11: 0 reports for this device; peer average 3/device2025-12: 0 reports for this device; peer average 4/device2026-01: 0 reports for this device; peer average 8/device2026-02: 0 reports for this device; peer average 2/device2026-03: 0 reports for this device; peer average 6/device2026-04: 0 reports for this device; peer average 4.5/device2026-06: 0 reports for this device; peer average 4/device06080102030708091011120102030406070809101112010305060708091011120102030405060708091011120102030405060708091011120102030405060708091011120102030406
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0603
2019-0803
2020-0106
2020-0203
2020-0303
2020-0704
2020-0804.5
2020-0903
2020-1003.5
2020-1102
2020-1203
2021-0101
2021-0202
2021-0302.5
2021-0401
2021-0601
2021-0702
2021-0801
2021-0902
2021-1002
2021-1101
2021-1203.5
2022-0103.5
2022-0302.5
2022-0502.33
2022-0602
2022-0701
2022-0802
2022-0904
2022-1007
2022-1102.5
2022-1204
2023-0104.25
2023-0205.67
2023-0306
2023-0407
2023-0503
2023-0603
2023-0705
2023-08010
2023-0904.5
2023-1002.75
2023-1105.5
2023-1205
2024-0102.33
2024-0205
2024-0302.67
2024-0402.75
2024-0501.5
2024-0603
2024-0701
2024-0803.5
2024-0901.75
2024-1002.25
2024-1107
2024-1208
2025-0101
2025-0206
2025-0301
2025-0404.5
2025-0504
2025-0605.5
2025-07012
2025-0802
2025-0905
2025-1004.5
2025-1103
2025-1204
2026-0108
2026-0202
2026-0306
2026-0404.5
2026-0604
This device (reports/month)Average device in FEM (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