Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 44
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- Carriere SLX 3D Clear (K173440): indications, design and recorded evidenceRegulatory decision evidence
- CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System (K231839): indications, design and recorded evidenceRegulatory decision evidence
- CastleLoc-S Posterior Cervical Fixation System (K231840): indications, design and recorded evidenceRegulatory decision evidence
- Catalyst CSR Shoulder System (K152825): indications, design and recorded evidenceRegulatory decision evidence
- Catalyst EA Convertible Stemmed Shoulder (K222317): indications, design and recorded evidenceRegulatory decision evidence
- Catapult Guide Sheath (K221914): indications, design and recorded evidenceRegulatory decision evidence
- Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm (US-34045-F-ST-H); Catapult Guide Sheath; 4F; 60cm (US-34060-F-ST-H); Catapult Guide Sheath; 4F; 90cm (US-34090-F-ST-H); Catapult Guide Sheath; 4F; 130cm (US-34130-F-ST-H); Catapult Guide Sheath; 5F; 15cm (US-35015-F-ST-H); Catapult Guide Sheath; 5F; 45cm (US-35045-F-ST-H); Catapult Guide Sheath; 5F; 45cm; Hockey Stick (US-35045-F-HS-H); Catapult Guide Sheath; 5F; 45cm; Multipurpose (US-35045-F-MP-H); Ca (K250439): indications, design and recorded evidenceRegulatory decision evidence
- Catheter For Crossing Total Occlusions (PDU) — FDA decisions, comparisons and evidenceFDA record research
- Catheter, Angiography, Reprocessed (NLI) — FDA decisions, comparisons and evidenceFDA record research
- Catheter, Biliary, Reprocessed (NML) — FDA decisions, comparisons and evidenceFDA record research
- Catheter, Drainage, Intraoral/Extraoral (OAJ) — FDA decisions, comparisons and evidenceFDA record research
- Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use (NQJ) — FDA decisions, comparisons and evidenceFDA record research
- Catheter, Percutaneous, Neurovasculature (QJP) — FDA decisions, comparisons and evidenceFDA record research
- Catheter, Recording, Electrode, Reprocessed (NLH) — FDA decisions, comparisons and evidenceFDA record research
- Catheter, Thrombus Retriever (NRY) — FDA decisions, comparisons and evidenceFDA record research
- Catheters, Transluminal Coronary Angioplasty, Percutaneous (LOX) — FDA decisions, comparisons and evidenceFDA record research
- Cathivex ¿GV filter units (K143583): indications, design and recorded evidenceRegulatory decision evidence
- Cavilon Advanced High Endurance Skin Protectant (K153571): indications, design and recorded evidenceRegulatory decision evidence
- Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port (K150010): indications, design and recorded evidenceRegulatory decision evidence
- Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx (K212071): indications, design and recorded evidenceRegulatory decision evidence
- Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label (K192020): indications, design and recorded evidenceRegulatory decision evidence
- Celerity HP Incubator (K190297): indications, design and recorded evidenceRegulatory decision evidence
- Cellulize (K180338): indications, design and recorded evidenceRegulatory decision evidence
- Cellusheet, Cellufil (K213092): indications, design and recorded evidenceRegulatory decision evidence
- Celsio Flexible Cryocatheter System (K240776): indications, design and recorded evidenceRegulatory decision evidence
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