Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 50
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- ControlRad Select Model Z (K213455): indications, design and recorded evidenceRegulatory decision evidence
- Controller, Temperature, Cardiopulmonary Bypass (DWC) — FDA decisions, comparisons and evidenceFDA record research
- ConvaVAC Negative Pressure Wound Therapy System (K253263): indications, design and recorded evidenceRegulatory decision evidence
- Cook 810 Set, Desilets-Hoffman Introducer Set (K180028): indications, design and recorded evidenceRegulatory decision evidence
- Cook Unimpregnated Central Venous Catheter (K182252): indications, design and recorded evidenceRegulatory decision evidence
- Cool Renewal (K161296): indications, design and recorded evidenceRegulatory decision evidence
- CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) (K251928): indications, design and recorded evidenceRegulatory decision evidence
- CoolSculpting Elite System (K212707): indications, design and recorded evidenceRegulatory decision evidence
- CoolTone (K220601): indications, design and recorded evidenceRegulatory decision evidence
- Coolief Radiofrequency Generator (CRG) System (K192491): indications, design and recorded evidenceRegulatory decision evidence
- Coolrail Linear Pen (K183065): indications, design and recorded evidenceRegulatory decision evidence
- Coolrail Linear Pen (K190587): indications, design and recorded evidenceRegulatory decision evidence
- CooperSurgical Advincula Delineator Uterine Manipulator (K143650): indications, design and recorded evidenceRegulatory decision evidence
- Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set (K182832): indications, design and recorded evidenceRegulatory decision evidence
- CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test (K240728): indications, design and recorded evidenceRegulatory decision evidence
- CorMatrix Tyke (K152127): indications, design and recorded evidenceRegulatory decision evidence
- CorVista System® with PCWP Add-On (K253576): indications, design and recorded evidenceRegulatory decision evidence
- CorVista® System (K232686): indications, design and recorded evidenceRegulatory decision evidence
- Cordelle II Sound Processor (K150751): indications, design and recorded evidenceRegulatory decision evidence
- Core Metabolic (K251157): indications, design and recorded evidenceRegulatory decision evidence
- Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®) (K230374): indications, design and recorded evidenceRegulatory decision evidence
- Coronis OneLook (K242008): indications, design and recorded evidenceRegulatory decision evidence
- Corplex P / Theracor P / Allacor P (K231325): indications, design and recorded evidenceRegulatory decision evidence
- Cortisol Saliva Luminescence Immunoassay (K150528): indications, design and recorded evidenceRegulatory decision evidence
- Cortium (K230614): indications, design and recorded evidenceRegulatory decision evidence
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