Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 25
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- AutoContour (Model RADAC V4) (K242729): indications, design and recorded evidenceRegulatory decision evidence
- AutoContour (RADAC V5) (K260509): indications, design and recorded evidenceRegulatory decision evidence
- AutoContour (RADAC V6) (K262452): indications, design and recorded evidenceRegulatory decision evidence
- AutoContour Model RADAC V2 (K220598): indications, design and recorded evidenceRegulatory decision evidence
- AutoContour Model RADAC V3 (K230685): indications, design and recorded evidenceRegulatory decision evidence
- Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking (NST) — FDA decisions, comparisons and evidenceFDA record research
- Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis (NIY) — FDA decisions, comparisons and evidenceFDA record research
- Autoantibodies, Glutamic Acid Decarboxylase (Gad) (NWG) — FDA decisions, comparisons and evidenceFDA record research
- Autoantibodies, Nuclear Body Protein, Sp100 (NUM) — FDA decisions, comparisons and evidenceFDA record research
- Autoantibodies, Nuclear Pore Glycoprotein Gp210 (NRI) — FDA decisions, comparisons and evidenceFDA record research
- Automated Blood Coagulation Analyzer CN-Series (CN-6000) (K250965): indications, design and recorded evidenceRegulatory decision evidence
- Automated Digital Image Manual Interpretation Microscope (OEO) — FDA decisions, comparisons and evidenceFDA record research
- Automated Intraoperative Spinal Rod Bending System (SIN) — FDA decisions, comparisons and evidenceFDA record research
- Automated Multicolor Fluorescent Imaging Cytometric Analysis System (PMG) — FDA decisions, comparisons and evidenceFDA record research
- Automated Occult Blood Analyzer (OOX) — FDA decisions, comparisons and evidenceFDA record research
- Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis (PER) — FDA decisions, comparisons and evidenceFDA record research
- Automated Radiological Image Processing Software (QIH) — FDA decisions, comparisons and evidenceFDA record research
- Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry (QQV) — FDA decisions, comparisons and evidenceFDA record research
- Automatic Event Detection Software For Full-Montage Electroencephalograph (OMB) — FDA decisions, comparisons and evidenceFDA record research
- Automatic Event Detection Software For Polysomnograph With Electroencephalograph (OLZ) — FDA decisions, comparisons and evidenceFDA record research
- Automatic Tissue Processing Unit (K172717): indications, design and recorded evidenceRegulatory decision evidence
- Autonomous Extracorporeal Blood Leak Detector/Alarm (ODX) — FDA decisions, comparisons and evidenceFDA record research
- Auxano® Wedge Fixation System (K251791): indications, design and recorded evidenceRegulatory decision evidence
- Avanti (K180660): indications, design and recorded evidenceRegulatory decision evidence
- Aveir Retrieval Catheter (K213494): indications, design and recorded evidenceRegulatory decision evidence
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