Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 213
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- Visby Medical Sexual Health Test (K220407): indications, design and recorded evidenceRegulatory decision evidence
- Viscoelastic Injector (K143205): indications, design and recorded evidenceRegulatory decision evidence
- Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head (K190449): indications, design and recorded evidenceRegulatory decision evidence
- Visibly Digital Acuity Product (K220090): indications, design and recorded evidenceRegulatory decision evidence
- Vision Monitor - MonpackONE (K211643): indications, design and recorded evidenceRegulatory decision evidence
- Vision Monitor- MonCvONE (K212936): indications, design and recorded evidenceRegulatory decision evidence
- Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427) (K252250): indications, design and recorded evidenceRegulatory decision evidence
- Vista Ophthalmics Vitrectomy Probe (K220030): indications, design and recorded evidenceRegulatory decision evidence
- VistaCam iX Proof (K150672): indications, design and recorded evidenceRegulatory decision evidence
- VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) (K240040): indications, design and recorded evidenceRegulatory decision evidence
- VisuMax Femtosecond Laser (K173371): indications, design and recorded evidenceRegulatory decision evidence
- Vit Kit- Freeze NX and Vit Kit- Warm NX (K190152): indications, design and recorded evidenceRegulatory decision evidence
- Vital Connect Platform, HealthPatch MD, VitalPatch (K152139): indications, design and recorded evidenceRegulatory decision evidence
- Vital Signs (K251200): indications, design and recorded evidenceRegulatory decision evidence
- VitalRhythm (K242129): indications, design and recorded evidenceRegulatory decision evidence
- Vitalograph Model 2120 In2itive eDiary (K200550): indications, design and recorded evidenceRegulatory decision evidence
- Vitalograph Model 6000 Alpha (K212938): indications, design and recorded evidenceRegulatory decision evidence
- Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System (ODV) — FDA decisions, comparisons and evidenceFDA record research
- VitreJect® Needle; OcuSafe® Needle (K230959): indications, design and recorded evidenceRegulatory decision evidence
- Vitreq disposable laser probes, light fibers and Chandelier (K182646): indications, design and recorded evidenceRegulatory decision evidence
- Vitruvian Liposaber (K240188): indications, design and recorded evidenceRegulatory decision evidence
- Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) (K163464): indications, design and recorded evidenceRegulatory decision evidence
- Vivid Pioneer (K251169): indications, design and recorded evidenceRegulatory decision evidence
- Vivid T9/Vivid T8 (K243628): indications, design and recorded evidenceRegulatory decision evidence
- Vivo 45 LS (K193586): indications, design and recorded evidenceRegulatory decision evidence
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