Cruxi research & evidence

FDA 510(k) Submission Services evidence guides — page 199

Compare documented facts, dated analyses and evidence that can change your project scope. Confirm applicability with a specialist.

• Test, Factor Ii G20210a Mutations, Genomic Dna Pcr (NPR) — FDA decisions, comparisons and evidenceFDA record research
• Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) (LOM) — FDA decisions, comparisons and evidenceFDA record research
• Test, Propoxyphene, Over The Counter (QBF) — FDA decisions, comparisons and evidenceFDA record research
• Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2 (NOE) — FDA decisions, comparisons and evidenceFDA record research
• TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) (K261098): indications, design and recorded evidenceRegulatory decision evidence
• Tetragraph Neuromuscular Transmission Monitor (K190795): indications, design and recorded evidenceRegulatory decision evidence
• Tetragraph Neuromuscular Transmission Monitor (K220530): indications, design and recorded evidenceRegulatory decision evidence
• Tetric plus Fill;Tetric plus Flow (K261485): indications, design and recorded evidenceRegulatory decision evidence
• The AIO Solution 3.0 (K202068): indications, design and recorded evidenceRegulatory decision evidence
• The BioBrace Implant (K203267): indications, design and recorded evidenceRegulatory decision evidence
• The C100 Contactless Breathing Monitor (K200445): indications, design and recorded evidenceRegulatory decision evidence
• The Cellfina System (K161885): indications, design and recorded evidenceRegulatory decision evidence
• The Gecko Spinal System (K200281): indications, design and recorded evidenceRegulatory decision evidence
• The Karma® Fixation System (K242527): indications, design and recorded evidenceRegulatory decision evidence
• The Lipogems System (K142682): indications, design and recorded evidenceRegulatory decision evidence
• The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter (K223788): indications, design and recorded evidenceRegulatory decision evidence
• The Optimotion™ Blue Plus Knee System (K240938): indications, design and recorded evidenceRegulatory decision evidence
• The Slide (K203712): indications, design and recorded evidenceRegulatory decision evidence
• The Solstice OCT System (K173047): indications, design and recorded evidenceRegulatory decision evidence
• The VEGA Cervical Screw System (K254260): indications, design and recorded evidenceRegulatory decision evidence
• The Vest Airway Clearance System (K142482): indications, design and recorded evidenceRegulatory decision evidence
• The iNAP One Sleep Therapy System (K193460): indications, design and recorded evidenceRegulatory decision evidence
• TheRay Collared and Collarless Femoral Stem (K241875): indications, design and recorded evidenceRegulatory decision evidence
• Theia NPWT Foam Wound Dressing Kit (K211277): indications, design and recorded evidenceRegulatory decision evidence
• TheraBase, TheraBase Ca (K192007): indications, design and recorded evidenceRegulatory decision evidence

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