Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 138
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- Numen Coil Embolization System; NumenFR Detachment System (K242154): indications, design and recorded evidenceRegulatory decision evidence
- Numen Helia Coil Embolization System; NumenFR Detachment System (K260351): indications, design and recorded evidenceRegulatory decision evidence
- Nurochek System (K200705): indications, design and recorded evidenceRegulatory decision evidence
- Nurture Rest (K172962): indications, design and recorded evidenceRegulatory decision evidence
- Nutra Face Lift Model PE8050 (K150826): indications, design and recorded evidenceRegulatory decision evidence
- Nutra Light Advanced (K150370): indications, design and recorded evidenceRegulatory decision evidence
- Nutricair Enteral Syringe with ENFit (K231300): indications, design and recorded evidenceRegulatory decision evidence
- Nutricair enteral ENFit adapter: ENFit male stepped/Christmas tree connector (K231299): indications, design and recorded evidenceRegulatory decision evidence
- NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System (K153479): indications, design and recorded evidenceRegulatory decision evidence
- NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System (K182616): indications, design and recorded evidenceRegulatory decision evidence
- NvisionVLE Low-profile Optical Probe (K191117): indications, design and recorded evidenceRegulatory decision evidence
- NxStage PureFlow Solution (K233213): indications, design and recorded evidenceRegulatory decision evidence
- NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) (K231758): indications, design and recorded evidenceRegulatory decision evidence
- O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set (K182066): indications, design and recorded evidenceRegulatory decision evidence
- O-PEP (K150044): indications, design and recorded evidenceRegulatory decision evidence
- O-TWO E700,O-TWO E600,O-TWO E500 (K141595): indications, design and recorded evidenceRegulatory decision evidence
- O2 Concepts Oxlife Independence Model 301-0001 (K182454): indications, design and recorded evidenceRegulatory decision evidence
- OARtrac System with Skin Sensors (K150719): indications, design and recorded evidenceRegulatory decision evidence
- OC-Auto SENSOR io iFOB Test (K191147): indications, design and recorded evidenceRegulatory decision evidence
- OC-FLEX Flexible IntraOral Cannula (K161250): indications, design and recorded evidenceRegulatory decision evidence
- OC-Light S FIT (K143325): indications, design and recorded evidenceRegulatory decision evidence
- OCS Heart Leukocyte Depleting Filter (K231362): indications, design and recorded evidenceRegulatory decision evidence
- OCS Lung Donor Flush Set (K222535): indications, design and recorded evidenceRegulatory decision evidence
- ODALYS Pedicle Screw System (K152098): indications, design and recorded evidenceRegulatory decision evidence
- ODFS Pace XL (K171396): indications, design and recorded evidenceRegulatory decision evidence
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