Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 62
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- Drive DeVilbiss iGo 2 Portable Oxygen Concentrator (K172648): indications, design and recorded evidenceRegulatory decision evidence
- DropSafeTM SicuraTM (K223353): indications, design and recorded evidenceRegulatory decision evidence
- Drug Relief (K173861): indications, design and recorded evidenceRegulatory decision evidence
- Drug Relief v1 (K221231): indications, design and recorded evidenceRegulatory decision evidence
- Dual Lumen Ecmo Cannula (PZS) — FDA decisions, comparisons and evidenceFDA record research
- Dual Stage Venous Cannulae (K253671): indications, design and recorded evidenceRegulatory decision evidence
- DualCap (K142806): indications, design and recorded evidenceRegulatory decision evidence
- Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2 (K150327): indications, design and recorded evidenceRegulatory decision evidence
- DuoprossTM Smart Cap (Type I) (K252518): indications, design and recorded evidenceRegulatory decision evidence
- Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) (K230395): indications, design and recorded evidenceRegulatory decision evidence
- DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 (K190298): indications, design and recorded evidenceRegulatory decision evidence
- DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent (K162208): indications, design and recorded evidenceRegulatory decision evidence
- DyeVert NG Contrast Modulation System (K161505): indications, design and recorded evidenceRegulatory decision evidence
- DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System (K163054): indications, design and recorded evidenceRegulatory decision evidence
- DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System (K171217): indications, design and recorded evidenceRegulatory decision evidence
- DyeVert NG Contrast Reduction System, DyeVert PLUS EZ Contrast Reduction System, DyeTect Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert PLUS EZ Contrast Reduction System (K183267): indications, design and recorded evidenceRegulatory decision evidence
- DyeVert Plus Contrast Reduction System, DyeTect Contrast Monitoring System, DyeVert Plus EZ Contrast Reduction System (K190102): indications, design and recorded evidenceRegulatory decision evidence
- Dynamic Gas Scavenging System 2 (DGSS - 2) (K193646): indications, design and recorded evidenceRegulatory decision evidence
- Dynamo Spinal Cement; Salvo® Spine System (K260286): indications, design and recorded evidenceRegulatory decision evidence
- D·Kaptain PTA High Pressure Balloon Dilatation Catheter (K214009): indications, design and recorded evidenceRegulatory decision evidence
- D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter (K242254): indications, design and recorded evidenceRegulatory decision evidence
- D·Kutting PTA Scoring Balloon Dilatation Catheter (K232207): indications, design and recorded evidenceRegulatory decision evidence
- E-PEN (E-PEN) (K243143): indications, design and recorded evidenceRegulatory decision evidence
- E-XPE Acetabular Components and U-Motion II Acetabular Cup (K172833): indications, design and recorded evidenceRegulatory decision evidence
- E-Z CHECK OZONE TEST STRIPS (K132344): indications, design and recorded evidenceRegulatory decision evidence
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