Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 49
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- Comet II Pressure Guidewire (K193279): indications, design and recorded evidenceRegulatory decision evidence
- Compact Wearable Pump (K230469): indications, design and recorded evidenceRegulatory decision evidence
- CompactCath Intermittent Urinary Catheter (K160858): indications, design and recorded evidenceRegulatory decision evidence
- Compass BDS Biliary Stent (K213946): indications, design and recorded evidenceRegulatory decision evidence
- Compass Cast and MAP (K161408): indications, design and recorded evidenceRegulatory decision evidence
- Complete Gene Expression Profiling Accessory Reagents (OVA) — FDA decisions, comparisons and evidenceFDA record research
- Composite Removable Sinus Stent System (K170913): indications, design and recorded evidenceRegulatory decision evidence
- Compound W Skin Tag Remover (K242803): indications, design and recorded evidenceRegulatory decision evidence
- Compressible Limb and Circulation Therapy System, Model POWER-Q2300 (K211283): indications, design and recorded evidenceRegulatory decision evidence
- Compression Therapy Device (LGT-2202DVT) (K250242): indications, design and recorded evidenceRegulatory decision evidence
- Computer Assisted Hair Harvesting System (ONA) — FDA decisions, comparisons and evidenceFDA record research
- Concentrix MX-AC High-Speed Handpiece (K173465): indications, design and recorded evidenceRegulatory decision evidence
- Concinnity Aligners (K200005): indications, design and recorded evidenceRegulatory decision evidence
- Conductive Gel (K222770): indications, design and recorded evidenceRegulatory decision evidence
- Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter (K171810): indications, design and recorded evidenceRegulatory decision evidence
- Confirm Rx Insertable Cardiac Monitor (K202876): indications, design and recorded evidenceRegulatory decision evidence
- Conformal Brachytherapy Source (ONL) — FDA decisions, comparisons and evidenceFDA record research
- Conformer, Ophthalmic, Biological Tissue (NQB) — FDA decisions, comparisons and evidenceFDA record research
- Conical Platform Dental Implants System (K240202): indications, design and recorded evidenceRegulatory decision evidence
- Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control (K254014): indications, design and recorded evidenceRegulatory decision evidence
- Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System (K251853): indications, design and recorded evidenceRegulatory decision evidence
- Contact Lens Case, Model: A-1, B-1 (K172925): indications, design and recorded evidenceRegulatory decision evidence
- Continuous Glucose Monitor Informed Insulin Dose Calculator (QRX) — FDA decisions, comparisons and evidenceFDA record research
- Contour 24 (K183111): indications, design and recorded evidenceRegulatory decision evidence
- Control Material, Blood Circulating Epithelial Cancer Cell (NRS) — FDA decisions, comparisons and evidenceFDA record research
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