Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 99
Compare documented facts, dated analyses and evidence that can change your project scope. Confirm applicability with a specialist.
Compare FDA 510(k) Submission Services providers- ISO 6872 Fifth edition 2024-08; ANSI ADA Standard No. 69-2025 — FDA recognition transition and report handoffCompliance research
- ISO 6877 Fourth edition 2025-08 — FDA recognition transition and report handoffCompliance research
- ISO 7176-21 Third edition 2025-04 — FDA recognition transition and report handoffCompliance research
- ISO 7199 Fourth edition 2024-09 — FDA recognition transition and report handoffCompliance research
- ISO 7206-12 Second edition 2025-11 — FDA recognition transition and report handoffCompliance research
- ISO 7207-2 Third edition 2025-08 — FDA recognition transition and report handoffCompliance research
- ISO 7376 Third edition 2020-08 [Including AMD1:2025] — FDA recognition transition and report handoffCompliance research
- ISO 80369-1 Third edition 2025-10 — FDA recognition transition and report handoffCompliance research
- ISO 80369-20 Second edition 2024-11 — FDA recognition transition and report handoffCompliance research
- ISO 80369-6 Second edition 2025-05 — FDA recognition transition and report handoffCompliance research
- ISO 80601-2-12 Third edition 2023-11 — FDA recognition transition and report handoffCompliance research
- ISO 80601-2-55 Second edition 2018-02 [Including AMD1:2023] — FDA recognition transition and report handoffCompliance research
- ISO 80601-2-70 Third edition 2025-11 — FDA recognition transition and report handoffCompliance research
- ISO 80601-2-72 Second edition 2023-06 — FDA recognition transition and report handoffCompliance research
- ISO 80601-2-74 Second edition 2021-07 — FDA recognition transition and report handoffCompliance research
- ISO 80601-2-79 Second edition 2024-08 — FDA recognition transition and report handoffCompliance research
- ISO 80601-2-84 Second edition 2023-11 — FDA recognition transition and report handoffCompliance research
- ISO 8536-2 Fourth edition 2023-01 — FDA recognition transition and report handoffCompliance research
- ISO IEEE 11073-20601-2019; ISO IEEE 11073-20601 Third Edition 2022-12 — FDA recognition transition and report handoffCompliance research
- ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System (K221872): indications, design and recorded evidenceRegulatory decision evidence
- IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM (K132640): indications, design and recorded evidenceRegulatory decision evidence
- IV Administration Set (K213778): indications, design and recorded evidenceRegulatory decision evidence
- Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH) (K250194): indications, design and recorded evidenceRegulatory decision evidence
- IceSense 3, ProSense, MultiSense (K183213): indications, design and recorded evidenceRegulatory decision evidence
- Iconix Speed Anchor; Iconix Speed HA+ Anchor (K252144): indications, design and recorded evidenceRegulatory decision evidence
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