Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 183
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- SleepImage System (K163696): indications, design and recorded evidenceRegulatory decision evidence
- SleepRight Select-Comfort Dental Guard (K212767): indications, design and recorded evidenceRegulatory decision evidence
- SleepWeaver Advance Pediatric Nasal CPAP Mask (K151683): indications, design and recorded evidenceRegulatory decision evidence
- Sleepiz One+ (K223163): indications, design and recorded evidenceRegulatory decision evidence
- Slinky Catheter (K231179): indications, design and recorded evidenceRegulatory decision evidence
- Slow Wave DS8 (SWDS802) (K240463): indications, design and recorded evidenceRegulatory decision evidence
- Small Bone Nailing System (K211439): indications, design and recorded evidenceRegulatory decision evidence
- Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit (K211571): indications, design and recorded evidenceRegulatory decision evidence
- Small VBR (K192117): indications, design and recorded evidenceRegulatory decision evidence
- Small Volume 0.2mL Syringe (K250138): indications, design and recorded evidenceRegulatory decision evidence
- Smart Syringe (K171698): indications, design and recorded evidenceRegulatory decision evidence
- Smart Wireless Stethoscope (K220470): indications, design and recorded evidenceRegulatory decision evidence
- Smart double sides wearable breast pump, Electric bilateral breast pump (K230102): indications, design and recorded evidenceRegulatory decision evidence
- SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare (K190512): indications, design and recorded evidenceRegulatory decision evidence
- SmartBolus Calculator (K222239): indications, design and recorded evidenceRegulatory decision evidence
- SmartGuard Anti-Snoring Device (K200657): indications, design and recorded evidenceRegulatory decision evidence
- SmartGuide Disposable Guides and Grids (K260161): indications, design and recorded evidenceRegulatory decision evidence
- SmartLinx Vitals Plus Patient Monitoring System (K180734): indications, design and recorded evidenceRegulatory decision evidence
- SmartSpectra Vital Signs Monitor 1.0 (K254169): indications, design and recorded evidenceRegulatory decision evidence
- SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm (K151536): indications, design and recorded evidenceRegulatory decision evidence
- Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs (K161154): indications, design and recorded evidenceRegulatory decision evidence
- Smartpump 3.0 Double Electric Breast Pump (K222726): indications, design and recorded evidenceRegulatory decision evidence
- Smith & Nephew 25 Fluid Management System (K171794): indications, design and recorded evidenceRegulatory decision evidence
- Smith and Nephew Legion Hinge Knee System (K151118): indications, design and recorded evidenceRegulatory decision evidence
- Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteoraptor Suture Anchor, Smith and Nephew Suture Anchors - Twinfix Ultra HA Suture Anchor, Smith and Nephew Suture Anchors - OSTEORAPTOR Curved Suture Anchors, Smith and Nephew Suture Anchors - Ultra Fast-Fix Meniscal Repair System, Ultra Fa (K151105): indications, design and recorded evidenceRegulatory decision evidence
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