Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 40
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- CO2 monitoring line with and without in-line filter (K143150): indications, design and recorded evidenceRegulatory decision evidence
- COBAS CT/NG V2.0 TEST (K132270): indications, design and recorded evidenceRegulatory decision evidence
- COBRA Fusion Ablation System (K190151): indications, design and recorded evidenceRegulatory decision evidence
- COCHLEAR BAHA IMPLANT SYSTEM (K121317): indications, design and recorded evidenceRegulatory decision evidence
- COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT (K182813): indications, design and recorded evidenceRegulatory decision evidence
- COLLAGEN DURA MEMBRANE (K141608): indications, design and recorded evidenceRegulatory decision evidence
- COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST (K140026): indications, design and recorded evidenceRegulatory decision evidence
- COLOSSEUM Mesh (K190147): indications, design and recorded evidenceRegulatory decision evidence
- COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal (K191933): indications, design and recorded evidenceRegulatory decision evidence
- COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter (K180738): indications, design and recorded evidenceRegulatory decision evidence
- COMPRESS ANTI-ROTATION SPINDLES (K101475): indications, design and recorded evidenceRegulatory decision evidence
- CONCORD Plus Radiopaque Bone Cement (K162618): indications, design and recorded evidenceRegulatory decision evidence
- CONNECTED CARE MOBILE APPLICATION (K120325): indications, design and recorded evidenceRegulatory decision evidence
- CONOD Enteral Feeding Sets (K181276): indications, design and recorded evidenceRegulatory decision evidence
- CONTINUOUS SINGLE CULTURE COMPLETE (K121572): indications, design and recorded evidenceRegulatory decision evidence
- CONTINUUM PACS (K200385): indications, design and recorded evidenceRegulatory decision evidence
- CONVIVO (K181116): indications, design and recorded evidenceRegulatory decision evidence
- COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPR (K121629): indications, design and recorded evidenceRegulatory decision evidence
- COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit (K143724): indications, design and recorded evidenceRegulatory decision evidence
- COPAL exchange G hip spacer (K220492): indications, design and recorded evidenceRegulatory decision evidence
- COPAL® exchange G hip spacer; COPAL® G+V (K234028): indications, design and recorded evidenceRegulatory decision evidence
- CORBEL Spacers (K201087): indications, design and recorded evidenceRegulatory decision evidence
- CORE 500 Digital Stethoscope (K230111): indications, design and recorded evidenceRegulatory decision evidence
- CORE 500 Digital Stethoscope (K233609): indications, design and recorded evidenceRegulatory decision evidence
- CORGRIP NG/NI Tube Retention System (K162110): indications, design and recorded evidenceRegulatory decision evidence
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