Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 124
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- MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System (K212743): indications, design and recorded evidenceRegulatory decision evidence
- MedSource CathMED IV Catheter (K193278): indications, design and recorded evidenceRegulatory decision evidence
- MedSource ClearSafe Safety IV Catheter (K150611): indications, design and recorded evidenceRegulatory decision evidence
- MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter (K161779): indications, design and recorded evidenceRegulatory decision evidence
- MediClear PreOp (K163556): indications, design and recorded evidenceRegulatory decision evidence
- MediRod Pedicle Screw System (K242764): indications, design and recorded evidenceRegulatory decision evidence
- Mediastinoscope, Surgical (EWY) — FDA decisions, comparisons and evidenceFDA record research
- Medical Device Data System (OUG) — FDA decisions, comparisons and evidenceFDA record research
- Medical Glove, Specialty (LZC) — FDA decisions, comparisons and evidenceFDA record research
- Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs (QSO) — FDA decisions, comparisons and evidenceFDA record research
- Medical Monofilament Sensory Screening Toool (K143068): indications, design and recorded evidenceRegulatory decision evidence
- Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E) (K223068): indications, design and recorded evidenceRegulatory decision evidence
- Medical Video Endoscope System (K230475): indications, design and recorded evidenceRegulatory decision evidence
- Medical electronic thermometer (FC01, FC02) (K240109): indications, design and recorded evidenceRegulatory decision evidence
- Medical-device cybersecurity: scope the device, SBOM and evidence traceabilityService decision and evidence guide
- Medicalgorithmics Unified Cardiac Rehabilitation System (K173969): indications, design and recorded evidenceRegulatory decision evidence
- Medicom Sterilization Pouch and Reel (K243431): indications, design and recorded evidenceRegulatory decision evidence
- Medicon Epiplating System (K241253): indications, design and recorded evidenceRegulatory decision evidence
- Medipoint Blood Lancets (K223480): indications, design and recorded evidenceRegulatory decision evidence
- Mediracer NCS (K190536): indications, design and recorded evidenceRegulatory decision evidence
- Medium-Term Adjunctive Predictive Cardiovascular Indicator (QNL) — FDA decisions, comparisons and evidenceFDA record research
- Medline ENfit OTC Feeding Syringe (K202285): indications, design and recorded evidenceRegulatory decision evidence
- Medline Epidural Catheter (K150731): indications, design and recorded evidenceRegulatory decision evidence
- Medline Integrated Arterial Catheter (K210548): indications, design and recorded evidenceRegulatory decision evidence
- Medline Luer Lock Syringes (K230235): indications, design and recorded evidenceRegulatory decision evidence
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