Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 154
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- Portable (Ultrasonic) Nebulizer (K230379): indications, design and recorded evidenceRegulatory decision evidence
- Portable Dental Operative Unit (SJH) — FDA decisions, comparisons and evidenceFDA record research
- Portable Liquid Oxygen Unit Stand (PCM) — FDA decisions, comparisons and evidenceFDA record research
- Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) (K233401): indications, design and recorded evidenceRegulatory decision evidence
- Portable Scalp Cooling System (K211526): indications, design and recorded evidenceRegulatory decision evidence
- Portable X-ray System (K172928): indications, design and recorded evidenceRegulatory decision evidence
- Portable oxygen concentrator (JAY-1000P) (K243833): indications, design and recorded evidenceRegulatory decision evidence
- Portex NRFit Epidural Needles (K172823): indications, design and recorded evidenceRegulatory decision evidence
- Portex® Lancet Point Spinal Needles with NRFit connectors, Portex® Pencil Point Spinal Needles with NRFit connectors (K172800): indications, design and recorded evidenceRegulatory decision evidence
- Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing (QZX) — FDA decisions, comparisons and evidenceFDA record research
- Posterior Cervical Screw Placement Guide (QSD) — FDA decisions, comparisons and evidenceFDA record research
- Posterior Cervical Screw System (NKG) — FDA decisions, comparisons and evidenceFDA record research
- Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5 (K221023): indications, design and recorded evidenceRegulatory decision evidence
- Posterior Metal/Polymer Spinal System, Fusion (NQP) — FDA decisions, comparisons and evidenceFDA record research
- Potenza Prime (K254185): indications, design and recorded evidenceRegulatory decision evidence
- Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs (K243959): indications, design and recorded evidenceRegulatory decision evidence
- Powder-Free Clear Vinyl Patient Examination Gloves (K190095): indications, design and recorded evidenceRegulatory decision evidence
- Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) (K232064): indications, design and recorded evidenceRegulatory decision evidence
- Powder-Free Guayle Rubber Examination Glove (OIG) — FDA decisions, comparisons and evidenceFDA record research
- Powder-Free Polychloroprene Patient Examination Glove (OPC) — FDA decisions, comparisons and evidenceFDA record research
- Power Wheelchair (N5515B) (K220747): indications, design and recorded evidenceRegulatory decision evidence
- Power Wheelchair, W5521 (K231508): indications, design and recorded evidenceRegulatory decision evidence
- Power Wheelchair, W5907 (Q50 R Carbon) (K220740): indications, design and recorded evidenceRegulatory decision evidence
- PowerLook Tomo Detection V2 Software (K182373): indications, design and recorded evidenceRegulatory decision evidence
- Powered Laser Surgical Instrument With MicrobeamFractional Output (ONG) — FDA decisions, comparisons and evidenceFDA record research
Page 154 of 228