Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 177
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- SafeSept Transseptal Guidewire (K170671): indications, design and recorded evidenceRegulatory decision evidence
- SafeSept® Transseptal Guidewire (SS-140) (K221707): indications, design and recorded evidenceRegulatory decision evidence
- SafeT T-Piece Resuscitator (K173373): indications, design and recorded evidenceRegulatory decision evidence
- Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) (K214075): indications, design and recorded evidenceRegulatory decision evidence
- Safety Blood Collection Needle (Without Needle Holder) (K222141): indications, design and recorded evidenceRegulatory decision evidence
- Safety Insulin Pen Needles (K213183): indications, design and recorded evidenceRegulatory decision evidence
- Safety Lancet (K222801): indications, design and recorded evidenceRegulatory decision evidence
- Safety Pen Needle for Single Use, Insulin Pen Needles (K212514): indications, design and recorded evidenceRegulatory decision evidence
- Safety Winged Blood Collection Sets (K211293): indications, design and recorded evidenceRegulatory decision evidence
- Safety Wire Guide Introducer (K180756): indications, design and recorded evidenceRegulatory decision evidence
- Saige-Dx (3.1.0) (K243688): indications, design and recorded evidenceRegulatory decision evidence
- Saige-Dx (K241747): indications, design and recorded evidenceRegulatory decision evidence
- Saige-Dx (K251873): indications, design and recorded evidenceRegulatory decision evidence
- Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection (K213174): indications, design and recorded evidenceRegulatory decision evidence
- SaliPen (K220618): indications, design and recorded evidenceRegulatory decision evidence
- Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device (QTI) — FDA decisions, comparisons and evidenceFDA record research
- SalivaMAX (K152406): indications, design and recorded evidenceRegulatory decision evidence
- Salvin Tenting Screw System (K161857): indications, design and recorded evidenceRegulatory decision evidence
- Samfilcon B Custom Contact Lens (K230954): indications, design and recorded evidenceRegulatory decision evidence
- Samsung ECG Monitor Application with Irregular Heart Rhythm Notification (K230292): indications, design and recorded evidenceRegulatory decision evidence
- SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile Ultrasonic Surgery Advanced Dissector (SASD45) (K242894): indications, design and recorded evidenceRegulatory decision evidence
- Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI)) (K210052): indications, design and recorded evidenceRegulatory decision evidence
- Saniclave 250 (K180272): indications, design and recorded evidenceRegulatory decision evidence
- Santreva-ATK Endovascular Revasculariztion Catheter (K252315): indications, design and recorded evidenceRegulatory decision evidence
- Sapphire II PRO (K173680): indications, design and recorded evidenceRegulatory decision evidence
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