Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 151
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- PerfusiX-Imaging (K254180): indications, design and recorded evidenceRegulatory decision evidence
- Perfusor® Space Syringe Infusion Pump System (K172831): indications, design and recorded evidenceRegulatory decision evidence
- PeriCoach OTC (K160758): indications, design and recorded evidenceRegulatory decision evidence
- Peridot Spinal Interbody System (K213980): indications, design and recorded evidenceRegulatory decision evidence
- Peripheral Mechanical Thrombectomy With Aspiration (QEW) — FDA decisions, comparisons and evidenceFDA record research
- Permanently Mounted Wheelchair Platform Lift (PCE) — FDA decisions, comparisons and evidenceFDA record research
- Permatage Settable Bone Putty (K241027): indications, design and recorded evidenceRegulatory decision evidence
- Permatage XT Settable Bone Putty (K261265): indications, design and recorded evidenceRegulatory decision evidence
- Personal Kinetigraph (PKG) System (K161717): indications, design and recorded evidenceRegulatory decision evidence
- Personalized Therapy Comfort Settings (PTCS) (K251657): indications, design and recorded evidenceRegulatory decision evidence
- Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) (K232372): indications, design and recorded evidenceRegulatory decision evidence
- PhAST instrument and PhAST Blood Culture Gram-negative Panel (K253316): indications, design and recorded evidenceRegulatory decision evidence
- Phantom Small Bone Intramedullary Nail System (K170693): indications, design and recorded evidenceRegulatory decision evidence
- Phasix Mesh (K142818): indications, design and recorded evidenceRegulatory decision evidence
- Phasix Mesh (K161424): indications, design and recorded evidenceRegulatory decision evidence
- Phasix ST Mesh (K143380): indications, design and recorded evidenceRegulatory decision evidence
- Phasor Drill (K161704): indications, design and recorded evidenceRegulatory decision evidence
- PhenoMATRIX (K251511): indications, design and recorded evidenceRegulatory decision evidence
- Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates (PTJ) — FDA decisions, comparisons and evidenceFDA record research
- Philips Biosensor BX100 (K192875): indications, design and recorded evidenceRegulatory decision evidence
- Philips IntelliSite Pathology Solution (K203845): indications, design and recorded evidenceRegulatory decision evidence
- Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn (K243545): indications, design and recorded evidenceRegulatory decision evidence
- Philips iCT CT system (K250648): indications, design and recorded evidenceRegulatory decision evidence
- Philips wearable biosensor-G5 Solution (K181165): indications, design and recorded evidenceRegulatory decision evidence
- Phoenix Wound Matrix (K173544): indications, design and recorded evidenceRegulatory decision evidence
Page 151 of 228