Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 224
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- epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test (K171247): indications, design and recorded evidenceRegulatory decision evidence
- eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) (K250207): indications, design and recorded evidenceRegulatory decision evidence
- evoDrill Cranial Perforator (K231403): indications, design and recorded evidenceRegulatory decision evidence
- exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft (K202471): indications, design and recorded evidenceRegulatory decision evidence
- exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts (K233783): indications, design and recorded evidenceRegulatory decision evidence
- exGraft, exGraft Carbon (K221628): indications, design and recorded evidenceRegulatory decision evidence
- extriCARE 1000 Negative Pressure Wound Therapy System (K213906): indications, design and recorded evidenceRegulatory decision evidence
- freeflex+ Transfer Adapter (K212445): indications, design and recorded evidenceRegulatory decision evidence
- gammaCore Sapphire (K180538): indications, design and recorded evidenceRegulatory decision evidence
- gammaCore Sapphire (K182369): indications, design and recorded evidenceRegulatory decision evidence
- gammaCore Sapphire (K191830): indications, design and recorded evidenceRegulatory decision evidence
- gammaCore Sapphire (K203546): indications, design and recorded evidenceRegulatory decision evidence
- gammaCore-2 (K172270): indications, design and recorded evidenceRegulatory decision evidence
- gammaCore-S (K171306): indications, design and recorded evidenceRegulatory decision evidence
- geko T-2 and geko Plus R-2 Neuromuscular Stimulators (K163125): indications, design and recorded evidenceRegulatory decision evidence
- gel-e Flex+ gel OTC (K192667): indications, design and recorded evidenceRegulatory decision evidence
- gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler (K172712): indications, design and recorded evidenceRegulatory decision evidence
- handLITE (TN19S) (K250224): indications, design and recorded evidenceRegulatory decision evidence
- hemochroma PLUS System (K182298): indications, design and recorded evidenceRegulatory decision evidence
- hyperion X5, NewTom GO, X-RADiUS COMPACT (K200688): indications, design and recorded evidenceRegulatory decision evidence
- i-STAT CG8+ cartridge with the i-STAT 1 System (K230275): indications, design and recorded evidenceRegulatory decision evidence
- i-STAT CG8+ cartridge with the i-STAT 1 System (K230300): indications, design and recorded evidenceRegulatory decision evidence
- i-STAT Crea cartridge with the i-STAT 1 System (K261039): indications, design and recorded evidenceRegulatory decision evidence
- i-STAT G cartridge with the i-STAT 1 System (K223755): indications, design and recorded evidenceRegulatory decision evidence
- i-STAT G3+ cartridge with the i-STAT 1 System (K223857): indications, design and recorded evidenceRegulatory decision evidence
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