Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 9
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- ARTIS genio floor; ARTIS icono.explore floor (K253752): indications, design and recorded evidenceRegulatory decision evidence
- ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A) (K241572): indications, design and recorded evidenceRegulatory decision evidence
- ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno (K254173): indications, design and recorded evidenceRegulatory decision evidence
- ARx® SAI Implant System (K241464): indications, design and recorded evidenceRegulatory decision evidence
- ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR (K141751): indications, design and recorded evidenceRegulatory decision evidence
- ASEPT Peritoneal Drainage System (K221779): indications, design and recorded evidenceRegulatory decision evidence
- ASME PVHO-1-2023 — FDA recognition transition and report handoffCompliance research
- ASTM E1262-24 — FDA recognition transition and report handoffCompliance research
- ASTM F1058-25 — FDA recognition transition and report handoffCompliance research
- ASTM F1091-25 — FDA recognition transition and report handoffCompliance research
- ASTM F1264-24 — FDA recognition transition and report handoffCompliance research
- ASTM F1295-24 — FDA recognition transition and report handoffCompliance research
- ASTM F1314-24 — FDA recognition transition and report handoffCompliance research
- ASTM F1350-24 — FDA recognition transition and report handoffCompliance research
- ASTM F1439-24 — FDA recognition transition and report handoffCompliance research
- ASTM F1541-24 — FDA recognition transition and report handoffCompliance research
- ASTM F1609-23 — FDA recognition transition and report handoffCompliance research
- ASTM F1611-20 (Reapproved 2024) — FDA recognition transition and report handoffCompliance research
- ASTM F1670/F1670M-24a — FDA recognition transition and report handoffCompliance research
- ASTM F1798-24 — FDA recognition transition and report handoffCompliance research
- ASTM F1841-25 — FDA recognition transition and report handoffCompliance research
- ASTM F1854-25 — FDA recognition transition and report handoffCompliance research
- ASTM F1862/F1862M-24 — FDA recognition transition and report handoffCompliance research
- ASTM F1877-24 — FDA recognition transition and report handoffCompliance research
- ASTM F1925-24 — FDA recognition transition and report handoffCompliance research
Page 9 of 228