Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 96
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- IMPELLA CONTROLLER (K093801): indications, design and recorded evidenceRegulatory decision evidence
- IMPULSE AND EXPO ANGIOGRAPHIC CATHETER (K120495): indications, design and recorded evidenceRegulatory decision evidence
- INCONTROL (K110179): indications, design and recorded evidenceRegulatory decision evidence
- INFINITI Ambi Angiographic Catheter (K232573): indications, design and recorded evidenceRegulatory decision evidence
- INFINITY OCT System (K163375): indications, design and recorded evidenceRegulatory decision evidence
- INHANCETM Shoulder System Humeral Stems and Stemless (K223211): indications, design and recorded evidenceRegulatory decision evidence
- INHANCE Shoulder System, Sterile Single Use Instrumentation (K231516): indications, design and recorded evidenceRegulatory decision evidence
- INITARY BETTER BLADDER-PEDIATRIC (K140321): indications, design and recorded evidenceRegulatory decision evidence
- INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE (K131590): indications, design and recorded evidenceRegulatory decision evidence
- INNI-CERA (K211308): indications, design and recorded evidenceRegulatory decision evidence
- INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream (K192843): indications, design and recorded evidenceRegulatory decision evidence
- INOUE BALLOON A (K220881): indications, design and recorded evidenceRegulatory decision evidence
- INOmax DSIR Plus MRI (K143213): indications, design and recorded evidenceRegulatory decision evidence
- INTEGRATE -C Interbody Fusion System (K222004): indications, design and recorded evidenceRegulatory decision evidence
- INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT (K120169): indications, design and recorded evidenceRegulatory decision evidence
- INVISIKNOT Ankle Syndesmosis Repair Kit (K162996): indications, design and recorded evidenceRegulatory decision evidence
- INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor (K182868): indications, design and recorded evidenceRegulatory decision evidence
- IOLMaster700 (K143275): indications, design and recorded evidenceRegulatory decision evidence
- IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035) (K254089): indications, design and recorded evidenceRegulatory decision evidence
- IPD Dental Implant Abutments (K240570): indications, design and recorded evidenceRegulatory decision evidence
- IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 (K191435): indications, design and recorded evidenceRegulatory decision evidence
- IPL Hair Removal Device (JM-843, JM-865, JM-638) (K241881): indications, design and recorded evidenceRegulatory decision evidence
- IPL Hair Removal Device (LS-T106, LS-T107, LS-T108) (K232499): indications, design and recorded evidenceRegulatory decision evidence
- IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG (K230549): indications, design and recorded evidenceRegulatory decision evidence
- IPL Treatment Device (MDSQMC-01) (K243123): indications, design and recorded evidenceRegulatory decision evidence
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