Cruxi research & evidence
FDA 510(k) Submission Services evidence guides
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- Tampon, Menstrual, Scented, Scented-Deodorized (HIL) — FDA decisions, comparisons and evidenceFDA record research
- 0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm) (K143093): indications, design and recorded evidenceRegulatory decision evidence
- 0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE, SF SYRINGE (K141311): indications, design and recorded evidenceRegulatory decision evidence
- 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe (K142620): indications, design and recorded evidenceRegulatory decision evidence
- 046 Zenith Flex (K190338): indications, design and recorded evidenceRegulatory decision evidence
- 074 Zenith Flex System (K181354): indications, design and recorded evidenceRegulatory decision evidence
- 0909FCB, 1212FCA (K212753): indications, design and recorded evidenceRegulatory decision evidence
- 0909FCC, 0909FCC-HS (K240371): indications, design and recorded evidenceRegulatory decision evidence
- 0909FCE, 0909FCE-HS (K253800): indications, design and recorded evidenceRegulatory decision evidence
- 1) PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture (K232246): indications, design and recorded evidenceRegulatory decision evidence
- 1.5T 16ch Breast Coil (K182958): indications, design and recorded evidenceRegulatory decision evidence
- 11-Dehydro Thromboxane B2 Kit, Urinary (OBW) — FDA decisions, comparisons and evidenceFDA record research
- 1212FCA (K202722): indications, design and recorded evidenceRegulatory decision evidence
- 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) (K162453): indications, design and recorded evidenceRegulatory decision evidence
- 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF (K231467): indications, design and recorded evidenceRegulatory decision evidence
- 14F iSLEEVE Introducer Set (K230051): indications, design and recorded evidenceRegulatory decision evidence
- 14Fr Colon Decompression Set, Macon Colon Decompression Set (K171619): indications, design and recorded evidenceRegulatory decision evidence
- 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality (K260185): indications, design and recorded evidenceRegulatory decision evidence
- 16ch Foot/ Ankle SPEEDER (K181697): indications, design and recorded evidenceRegulatory decision evidence
- 16ch T/R Hand Wrist Coil (K162623): indications, design and recorded evidenceRegulatory decision evidence
- 16ch T/R Hand Wrist Coil (K173469): indications, design and recorded evidenceRegulatory decision evidence
- 16ch T/R Knee Coil (K162029): indications, design and recorded evidenceRegulatory decision evidence
- 1717SCV, 1717SGV (K201796): indications, design and recorded evidenceRegulatory decision evidence
- 18ch T/R Knee Coil (K150331): indications, design and recorded evidenceRegulatory decision evidence
- 1ML UNITRACT 27G X 1/2 TUBERCULIN SYRINGE, MODEL 132BY2-1 (K100998): indications, design and recorded evidenceRegulatory decision evidence
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