Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 106
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- Invictus OCT Spinal Fixation System (K203125): indications, design and recorded evidenceRegulatory decision evidence
- Invictus® Bone Cement, Invictus Spinal Fixation System (K221926): indications, design and recorded evidenceRegulatory decision evidence
- Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System (K261284): indications, design and recorded evidenceRegulatory decision evidence
- Invisalign System (K220287): indications, design and recorded evidenceRegulatory decision evidence
- Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (K232233): indications, design and recorded evidenceRegulatory decision evidence
- Inzii Ripstop Redeployable Retrieval System (K232880): indications, design and recorded evidenceRegulatory decision evidence
- Iodinated Contrast Media Transfer Tubing Set (PQH) — FDA decisions, comparisons and evidenceFDA record research
- Ion 3D (K243265): indications, design and recorded evidenceRegulatory decision evidence
- Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe) (K212048): indications, design and recorded evidenceRegulatory decision evidence
- Ion-C Navigation Instruments (K260329): indications, design and recorded evidenceRegulatory decision evidence
- Ion-L Navigated Instruments (K262121): indications, design and recorded evidenceRegulatory decision evidence
- IontoDC (K170291): indications, design and recorded evidenceRegulatory decision evidence
- Iovera System (K211334): indications, design and recorded evidenceRegulatory decision evidence
- Irrigation Tubing with CO2 or Air (K193250): indications, design and recorded evidenceRegulatory decision evidence
- Irrigation/Urology Sets (K254111): indications, design and recorded evidenceRegulatory decision evidence
- Isolator® Linear Pen (MLP1); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1) (K221358): indications, design and recorded evidenceRegulatory decision evidence
- Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100) (K252056): indications, design and recorded evidenceRegulatory decision evidence
- Isopure Dry Acid Dissolution System (K191093): indications, design and recorded evidenceRegulatory decision evidence
- Ivenix Infusion System (IIS) (K183311): indications, design and recorded evidenceRegulatory decision evidence
- J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle, (K190177): indications, design and recorded evidenceRegulatory decision evidence
- JADE Mobile X-Ray (K183388): indications, design and recorded evidenceRegulatory decision evidence
- JAZZ LOCK (K153348): indications, design and recorded evidenceRegulatory decision evidence
- JAZZ SYSTEM (K132287): indications, design and recorded evidenceRegulatory decision evidence
- JAZZ SYSTEM (K133617): indications, design and recorded evidenceRegulatory decision evidence
- JAZZ Spinal System (K240392): indications, design and recorded evidenceRegulatory decision evidence
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