Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 27
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- BD BACTEC PLUS ANAEROBIC/F (PLASTIC) (K141810): indications, design and recorded evidenceRegulatory decision evidence
- BD BACTEC Peds Plus/F Culture Vials (plastic) (K151866): indications, design and recorded evidenceRegulatory decision evidence
- BD BACTEC Plus Aerobic/F Culture Vials (K222591): indications, design and recorded evidenceRegulatory decision evidence
- BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) (K221826): indications, design and recorded evidenceRegulatory decision evidence
- BD BBL Sensi-Disc Lefamulin 20µg (LMU-20) (K230651): indications, design and recorded evidenceRegulatory decision evidence
- BD Intelliport System (K182092): indications, design and recorded evidenceRegulatory decision evidence
- BD Kiestra IdentifA (K222563): indications, design and recorded evidenceRegulatory decision evidence
- BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App (K213280): indications, design and recorded evidenceRegulatory decision evidence
- BD MAX CT/GC/TV, BD MAX INSTRUMENT (K151589): indications, design and recorded evidenceRegulatory decision evidence
- BD MAX CTGCTV2, BD MAX System (K182692): indications, design and recorded evidenceRegulatory decision evidence
- BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel (K181711): indications, design and recorded evidenceRegulatory decision evidence
- BD Nano 2nd Gen Pen Needle (K212015): indications, design and recorded evidenceRegulatory decision evidence
- BD Nano 2nd Gen Pen Needle (K213156): indications, design and recorded evidenceRegulatory decision evidence
- BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML) (K132909): indications, design and recorded evidenceRegulatory decision evidence
- BD Pen Needle (K213478): indications, design and recorded evidenceRegulatory decision evidence
- BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle (K211085): indications, design and recorded evidenceRegulatory decision evidence
- BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL) (K173252): indications, design and recorded evidenceRegulatory decision evidence
- BD Phoenix Automated Microbiology System GN Ceftaroline (0.0156-4 µg/mL) (K190905): indications, design and recorded evidenceRegulatory decision evidence
- BD Preset Syringe & BD A-Line Syringe (K202446): indications, design and recorded evidenceRegulatory decision evidence
- BD Prevue II Peripheral Vascular Vascular Access System (K211193): indications, design and recorded evidenceRegulatory decision evidence
- BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device (K233021): indications, design and recorded evidenceRegulatory decision evidence
- BD Surgiphor Antimicrobial Irrigation System (K213616): indications, design and recorded evidenceRegulatory decision evidence
- BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV (K132456): indications, design and recorded evidenceRegulatory decision evidence
- BD Veritor System for SARS-CoV-2 (K243872): indications, design and recorded evidenceRegulatory decision evidence
- BE MICRO, TREA (K093728): indications, design and recorded evidenceRegulatory decision evidence
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