Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 227
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- myVision Track Model 005 (K143211): indications, design and recorded evidenceRegulatory decision evidence
- neXus Ultrasonic Surgical Aspirator System (K190160): indications, design and recorded evidenceRegulatory decision evidence
- neXus Ultrasonic Surgical Aspirator System (K212060): indications, design and recorded evidenceRegulatory decision evidence
- neuro inspire (K163666): indications, design and recorded evidenceRegulatory decision evidence
- nextaro® v, 20/20 (K240748): indications, design and recorded evidenceRegulatory decision evidence
- ologen Collagen Matrix (K173223): indications, design and recorded evidenceRegulatory decision evidence
- pNOVUS 21 Microcatheter (K242420): indications, design and recorded evidenceRegulatory decision evidence
- primaLOK SP Interspinous Fusion System (K231807): indications, design and recorded evidenceRegulatory decision evidence
- primeMidline Catheters (K173114): indications, design and recorded evidenceRegulatory decision evidence
- primeMidline Catheters (K192802): indications, design and recorded evidenceRegulatory decision evidence
- prolaio eVO2peak Module (Version 1.0) (K252204): indications, design and recorded evidenceRegulatory decision evidence
- qER (K200921): indications, design and recorded evidenceRegulatory decision evidence
- qXR-PTX-PE (K230899): indications, design and recorded evidenceRegulatory decision evidence
- restor3d TIDAL Lumbar Interbody Fusion System (K234087): indications, design and recorded evidenceRegulatory decision evidence
- s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System (K173860): indications, design and recorded evidenceRegulatory decision evidence
- sOLVe Tube (K201026): indications, design and recorded evidenceRegulatory decision evidence
- staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, staysafe catheter extension set with Luer-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 18 inch, staysafe to Luer-Lock adapter, 4 inch (K173593): indications, design and recorded evidenceRegulatory decision evidence
- syngo.CT Brain Hemorrhage (K232431): indications, design and recorded evidenceRegulatory decision evidence
- syngo.CT Coronary Cockpit (K253786): indications, design and recorded evidenceRegulatory decision evidence
- syngo.CT LVO Detection (K243145): indications, design and recorded evidenceRegulatory decision evidence
- t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater (K160482): indications, design and recorded evidenceRegulatory decision evidence
- troCarWash System (K233442): indications, design and recorded evidenceRegulatory decision evidence
- truFreeze Rapid AV Spray Kit (K171522): indications, design and recorded evidenceRegulatory decision evidence
- truFreeze System (K171626): indications, design and recorded evidenceRegulatory decision evidence
- truFreeze System (K172041): indications, design and recorded evidenceRegulatory decision evidence
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