Cruxi research & evidence

FDA 510(k) Submission Services evidence guides — page 104

Compare documented facts, dated analyses and evidence that can change your project scope. Confirm applicability with a specialist.

• Integral Titanium Cervical Interbody (K222015): indications, design and recorded evidenceRegulatory decision evidence
• Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter (SBH) — FDA decisions, comparisons and evidenceFDA record research
• Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter (SAF) — FDA decisions, comparisons and evidenceFDA record research
• Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management (QDK) — FDA decisions, comparisons and evidenceFDA record research
• Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use (QII) — FDA decisions, comparisons and evidenceFDA record research
• Integrated Continuous Glucose Monitoring System For Professional Retrospective Use (QDL) — FDA decisions, comparisons and evidenceFDA record research
• Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems (QLG) — FDA decisions, comparisons and evidenceFDA record research
• Integrity Implant (K223538): indications, design and recorded evidenceRegulatory decision evidence
• Integrity-SI Fusion System (K222512): indications, design and recorded evidenceRegulatory decision evidence
• IntelAir Nasal Airway Support System (K142467): indications, design and recorded evidenceRegulatory decision evidence
• IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) (K230824): indications, design and recorded evidenceRegulatory decision evidence
• Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF) (K251173): indications, design and recorded evidenceRegulatory decision evidence
• InterCollagen® Guide (K223912): indications, design and recorded evidenceRegulatory decision evidence
• InterOss Collagen (K221808): indications, design and recorded evidenceRegulatory decision evidence
• InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm) (K150322): indications, design and recorded evidenceRegulatory decision evidence
• Interlude Rolled Tampons in Plastic Applicator (K191431): indications, design and recorded evidenceRegulatory decision evidence
• Intermittent nelaton catheter for single use (K222677): indications, design and recorded evidenceRegulatory decision evidence
• Internal Polymerase Chain Reaction Control, Not Assay Specific (OLD) — FDA decisions, comparisons and evidenceFDA record research
• Internal Distraction - Sterile (K161470): indications, design and recorded evidenceRegulatory decision evidence
• Internal Distraction - Sterile (K163315): indications, design and recorded evidenceRegulatory decision evidence
• Internal Hinged Elbow Fixator (OZI) — FDA decisions, comparisons and evidenceFDA record research
• Internal Joint Stabilizer - Elbow (K223318): indications, design and recorded evidenceRegulatory decision evidence
• Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus (K260507): indications, design and recorded evidenceRegulatory decision evidence
• Interoperable Automated Glycemic Controller, Insulin Suspend (QJS) — FDA decisions, comparisons and evidenceFDA record research
• Interventional Fluoroscopic X-Ray System (OWB) — FDA decisions, comparisons and evidenceFDA record research

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