Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 105
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- Intervertebral Fusion Device With Bone Graft, Cervical (ODP) — FDA decisions, comparisons and evidenceFDA record research
- Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) — FDA decisions, comparisons and evidenceFDA record research
- Intervertebral Fusion Device With Integrated Fixation, Cervical (OVE) — FDA decisions, comparisons and evidenceFDA record research
- Intervertebral Fusion Device With Integrated Fixation, Lumbar (OVD) — FDA decisions, comparisons and evidenceFDA record research
- Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035) (K261329): indications, design and recorded evidenceRegulatory decision evidence
- IntraOp Alignment System (K240199): indications, design and recorded evidenceRegulatory decision evidence
- IntraSight Plus (K253714): indications, design and recorded evidenceRegulatory decision evidence
- Intracavitary/Interstitial System (K250289): indications, design and recorded evidenceRegulatory decision evidence
- Intracept Intraosseous Nerve Ablation System (K222281): indications, design and recorded evidenceRegulatory decision evidence
- Intraoral Pressure Gradient Device (OZR) — FDA decisions, comparisons and evidenceFDA record research
- Intraosseous Fusion Device System (K231649): indications, design and recorded evidenceRegulatory decision evidence
- Intraosseous Infusion Needles (K250724): indications, design and recorded evidenceRegulatory decision evidence
- Intravascular Extension Set (K210430): indications, design and recorded evidenceRegulatory decision evidence
- Introcan Safety 3 Closed IV Catheter (K163358): indications, design and recorded evidenceRegulatory decision evidence
- Introcan Safety 3 Closed IV Catheter (K182870): indications, design and recorded evidenceRegulatory decision evidence
- Introcan Safety 3 Closed IV Catheter (K213085): indications, design and recorded evidenceRegulatory decision evidence
- Introcan Safety® 2 IV Catheter (K241845): indications, design and recorded evidenceRegulatory decision evidence
- Introcan Safety® Deep Access XL IV Catheter (K253235): indications, design and recorded evidenceRegulatory decision evidence
- Intuitive Surgical Vessel Sealer Extend (K183107): indications, design and recorded evidenceRegulatory decision evidence
- Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair (K162621): indications, design and recorded evidenceRegulatory decision evidence
- Invia Abdominal Dressing Kit (K182191): indications, design and recorded evidenceRegulatory decision evidence
- Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion 120 days, Invia Motion 60 days, Invia Motion 30 days, Invia Motion 15 days, Invia Motion 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad (K172145): indications, design and recorded evidenceRegulatory decision evidence
- Invia White Foam NPWT (K180415): indications, design and recorded evidenceRegulatory decision evidence
- Invictus Bands System (K253615): indications, design and recorded evidenceRegulatory decision evidence
- Invictus CT Spinal Fixation System (K200936): indications, design and recorded evidenceRegulatory decision evidence
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