Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 180
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- Shielded Applicator Set, Cervical Stop (K151657): indications, design and recorded evidenceRegulatory decision evidence
- Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410) (K233341): indications, design and recorded evidenceRegulatory decision evidence
- Shinetell PlusTM Digital Early Pregnancy Test (K251053): indications, design and recorded evidenceRegulatory decision evidence
- Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System (K241466): indications, design and recorded evidenceRegulatory decision evidence
- Shoreline Threaded TruProfile® Plate (K211903): indications, design and recorded evidenceRegulatory decision evidence
- Shoulder Arthroplasty Implantation System (QHE) — FDA decisions, comparisons and evidenceFDA record research
- Shoulder Innovations Total Shoulder System (K213615): indications, design and recorded evidenceRegulatory decision evidence
- Shoulder Prosthesis, Reverse Configuration (PHX) — FDA decisions, comparisons and evidenceFDA record research
- SiJoin®T3 (K213815): indications, design and recorded evidenceRegulatory decision evidence
- Siemens 3.0T PROCURE Array Coil (K142676): indications, design and recorded evidenceRegulatory decision evidence
- Sienna Ultimate Wireless Amplifier (K171397): indications, design and recorded evidenceRegulatory decision evidence
- Sientra, inc. Portfinder (K221127): indications, design and recorded evidenceRegulatory decision evidence
- Sight OLO (K190898): indications, design and recorded evidenceRegulatory decision evidence
- SignalNED System (Model RE) (K251726): indications, design and recorded evidenceRegulatory decision evidence
- Signature ONE System (K261510): indications, design and recorded evidenceRegulatory decision evidence
- Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapter XL Length (SIGCIRXL) (K240881): indications, design and recorded evidenceRegulatory decision evidence
- Silatrix Oral Gel (K252425): indications, design and recorded evidenceRegulatory decision evidence
- Silent Nite sl (K183270): indications, design and recorded evidenceRegulatory decision evidence
- Silicone Foley Catheter for single use (K172807): indications, design and recorded evidenceRegulatory decision evidence
- Silicone Peripherally Inserted Central Venous Catheter Set/Tray (K171994): indications, design and recorded evidenceRegulatory decision evidence
- Silk Voice (SMI-04) (K240919): indications, design and recorded evidenceRegulatory decision evidence
- SilverCeuticals® Antimicrobial Wound Gel (K251929): indications, design and recorded evidenceRegulatory decision evidence
- Silverlon Wound Contact, Burn Contact Dressings (K221218): indications, design and recorded evidenceRegulatory decision evidence
- Sim&Size (K190049): indications, design and recorded evidenceRegulatory decision evidence
- Sim&Size (K202322): indications, design and recorded evidenceRegulatory decision evidence
Page 180 of 228