Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 43
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- CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large) (K182255): indications, design and recorded evidenceRegulatory decision evidence
- CanGaroo RM Antibacterial Envelope (K233991): indications, design and recorded evidenceRegulatory decision evidence
- CanMINI Hand and Foot System (K242973): indications, design and recorded evidenceRegulatory decision evidence
- Cannula, Injector, Uterine, Endometrial Biopsy (PGK) — FDA decisions, comparisons and evidenceFDA record research
- Cannula, Trocar, Ophthalmic (NGY) — FDA decisions, comparisons and evidenceFDA record research
- Cannulated PsiFGuard (K241895): indications, design and recorded evidenceRegulatory decision evidence
- Capillary Blood Collection Device For Alternative Site Collection (PRJ) — FDA decisions, comparisons and evidenceFDA record research
- Capillus 112, Capillus 244 (K192012): indications, design and recorded evidenceRegulatory decision evidence
- Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202 (K160285): indications, design and recorded evidenceRegulatory decision evidence
- Capillus82 (K151516): indications, design and recorded evidenceRegulatory decision evidence
- CapsoCam Plus (SV-3) Capsule Endoscope System (K161773): indications, design and recorded evidenceRegulatory decision evidence
- Caption Guidance (K200755): indications, design and recorded evidenceRegulatory decision evidence
- Cardiac Amyloidosis Machine Learning-Based Notification Software (SHP) — FDA decisions, comparisons and evidenceFDA record research
- CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System (K151545): indications, design and recorded evidenceRegulatory decision evidence
- CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ); CardioCurve Steerable Sheath Large Curl, 40cm (CC-1040L ); CardioCurve Steerable Sheath Small Curl, 61cm (CC-1061S); CardioCurve Steerable Sheath Medium Curl, 61cm (CC-1061M ); CardioCurve Steerable Sheath Large Curl, 61cm (CC-1061L); CardioCurve Steerable Sheath Small Curl, 71cm (CC-1071S ); CardioCurve Steerable Sheath Medium Curl, 71cm (CC-1071M ); CardioCurve Steer (K240004): indications, design and recorded evidenceRegulatory decision evidence
- CardioSTAT® ECG Test Solution (K223049): indications, design and recorded evidenceRegulatory decision evidence
- CardioVision (K251293): indications, design and recorded evidenceRegulatory decision evidence
- Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device (K223508): indications, design and recorded evidenceRegulatory decision evidence
- Cardioblate Gemini-s Surgical Ablation Device (K200514): indications, design and recorded evidenceRegulatory decision evidence
- Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device (K190623): indications, design and recorded evidenceRegulatory decision evidence
- Carecube Negative Pressure Isolation Chamber (K231256): indications, design and recorded evidenceRegulatory decision evidence
- Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue (K232389): indications, design and recorded evidenceRegulatory decision evidence
- Carestation 750/750c (K213867): indications, design and recorded evidenceRegulatory decision evidence
- Carevix Suction Cervical Stabilizer (K223866): indications, design and recorded evidenceRegulatory decision evidence
- Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System (K213211): indications, design and recorded evidenceRegulatory decision evidence
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