Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 67
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- EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM (K131298): indications, design and recorded evidenceRegulatory decision evidence
- EXALT Model B Single-Use Bronchoscope (K222014): indications, design and recorded evidenceRegulatory decision evidence
- EXETER Centralizer, EXETER 2.5mm Plug (K191414): indications, design and recorded evidenceRegulatory decision evidence
- EXHALATION VALVE (K132143): indications, design and recorded evidenceRegulatory decision evidence
- EXPLORER AIR® II (K222240): indications, design and recorded evidenceRegulatory decision evidence
- EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM (K133110): indications, design and recorded evidenceRegulatory decision evidence
- EXTENDED LIFE BATTERY (K120350): indications, design and recorded evidenceRegulatory decision evidence
- EXULT Knee Replacement System (K242401): indications, design and recorded evidenceRegulatory decision evidence
- EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA (K123370): indications, design and recorded evidenceRegulatory decision evidence
- EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device) (K253541): indications, design and recorded evidenceRegulatory decision evidence
- EZ-Inject Single use Needle (K192222): indications, design and recorded evidenceRegulatory decision evidence
- EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits (K251274): indications, design and recorded evidenceRegulatory decision evidence
- EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device (K202270): indications, design and recorded evidenceRegulatory decision evidence
- EZ-TRAXTM Persona Knee Containment Device (K211007): indications, design and recorded evidenceRegulatory decision evidence
- EZstim*III Peripheral Nerve Stimulator/Nerve Locator (K162048): indications, design and recorded evidenceRegulatory decision evidence
- Ear Pressure Relief Device(Model:ER813B) (K230502): indications, design and recorded evidenceRegulatory decision evidence
- Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103) (K250470): indications, design and recorded evidenceRegulatory decision evidence
- Early Growth Response 1 (Egr) Fish Probe Kit (OWK) — FDA decisions, comparisons and evidenceFDA record research
- EasyWhip Family (K261021): indications, design and recorded evidenceRegulatory decision evidence
- Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle (K252908): indications, design and recorded evidenceRegulatory decision evidence
- Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) (K250610): indications, design and recorded evidenceRegulatory decision evidence
- Easyscreen (K171506): indications, design and recorded evidenceRegulatory decision evidence
- Ebony PTA 0.014 RX Peripheral Dilatation Catheter (K142459): indications, design and recorded evidenceRegulatory decision evidence
- Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black (K183435): indications, design and recorded evidenceRegulatory decision evidence
- Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm (K202665): indications, design and recorded evidenceRegulatory decision evidence
Page 67 of 228