Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 61
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- Disposable ureteral access sheath (K243710): indications, design and recorded evidenceRegulatory decision evidence
- Disposable ureteral stent (K243830): indications, design and recorded evidenceRegulatory decision evidence
- DistaSense(TM) (v1) (K254058): indications, design and recorded evidenceRegulatory decision evidence
- Distal Access Catheter (K231218): indications, design and recorded evidenceRegulatory decision evidence
- Distal Access Catheter (K233205): indications, design and recorded evidenceRegulatory decision evidence
- Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing (K222734): indications, design and recorded evidenceRegulatory decision evidence
- Dna Genetic Analyzer (PCA) — FDA decisions, comparisons and evidenceFDA record research
- Dna-Probe Kit, Human Chromosome (OYU) — FDA decisions, comparisons and evidenceFDA record research
- Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment (OXP) — FDA decisions, comparisons and evidenceFDA record research
- Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus (K242428): indications, design and recorded evidenceRegulatory decision evidence
- Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup (K232659): indications, design and recorded evidenceRegulatory decision evidence
- Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro (K250067): indications, design and recorded evidenceRegulatory decision evidence
- Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard (K240698): indications, design and recorded evidenceRegulatory decision evidence
- Dome Electrode (K190416): indications, design and recorded evidenceRegulatory decision evidence
- Dormiva Anti-Snoring Mouth Guard (K261134): indications, design and recorded evidenceRegulatory decision evidence
- Dornier Ureteral Stent (K190312): indications, design and recorded evidenceRegulatory decision evidence
- Double Internal Joint Stabilizer- Elbow (K231447): indications, design and recorded evidenceRegulatory decision evidence
- Double Lumen Ovum Aspiration Needles (K171611): indications, design and recorded evidenceRegulatory decision evidence
- DoubleChek DC-1001 (K212316): indications, design and recorded evidenceRegulatory decision evidence
- DragonFly Surgical Drill System (K161376): indications, design and recorded evidenceRegulatory decision evidence
- Dragonfly Pancreaticobiliary Scope; Dragonfly Digital Controller; Dragonfly Instrument Channel Caps (K233752): indications, design and recorded evidenceRegulatory decision evidence
- Drainage Catheter With Antibiotic (OEI) — FDA decisions, comparisons and evidenceFDA record research
- Dreem 3S (K242094): indications, design and recorded evidenceRegulatory decision evidence
- Drill, Battery Powered, Subungual Hematoma (NWF) — FDA decisions, comparisons and evidenceFDA record research
- Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed (NLN) — FDA decisions, comparisons and evidenceFDA record research
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