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ADVANCED STRETCHER, HAND-CARRIED

Model ST-100 · ADVANCED INSTRUMENTATIONS, INC. · DI B510ST1000

FPP — Stretcher, Hand-Carried · Class I · 21 CFR 880.6900

UDILibrary device dossier · generated 2026-09-10 · 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.

13452019-04: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 1/device2021-04: 0 reports for this device; peer average 1/device2022-01: 0 reports for this device; peer average 1/device2023-06: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1/device2025-02: 0 reports for this device; peer average 2/device2025-03: 0 reports for this device; peer average 4/device2025-04: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 5/device2025-07: 0 reports for this device; peer average 2/device2025-08: 0 reports for this device; peer average 2/device2025-09: 0 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 4.5/device2026-05: 0 reports for this device; peer average 2.5/device0407040106100408010203040506070809110105
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0401
2019-0701
2021-0401
2022-0101
2023-0601
2023-1002
2024-0401
2024-0801
2025-0101
2025-0202
2025-0304
2025-0401
2025-0502
2025-0605
2025-0702
2025-0802
2025-0902
2025-1102
2026-0104.5
2026-0502.5
This device (reports/month)Average device in FPP (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — ADVANCED INSTRUMENTATIONS, INC.

  • OAI 2025-04-17 Advanced Instrumentations, Inc. · 5 citations
  • OAI 2025-04-17 Advanced Instrumentations, Inc. · 5 citations
  • VAI 2024-02-26 Advanced Instrumentations, Inc. · 3 citations
  • VAI 2024-02-26 Advanced Instrumentations, Inc. · 3 citations
  • VAI 2023-03-10 Advanced Instrumentations, Inc. · 4 citations
  • VAI 2023-03-10 Advanced Instrumentations, Inc. · 4 citations
  • VAI 2020-01-15 Advanced Instrumentations, Inc. · 3 citations
  • VAI 2020-01-15 Advanced Instrumentations, Inc. · 3 citations
  • VAI 2013-06-14 Advanced Instrumentations, Inc. · 6 citations
  • VAI 2013-06-14 Advanced Instrumentations, Inc. · 6 citations