Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 80
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- First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (K151441): indications, design and recorded evidenceRegulatory decision evidence
- First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test (K142353): indications, design and recorded evidenceRegulatory decision evidence
- Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis (OAH) — FDA decisions, comparisons and evidenceFDA record research
- Fist Assist Devices Model FA-1 (K210281): indications, design and recorded evidenceRegulatory decision evidence
- Fitbit Irregular Rhythm Notifications (K212372): indications, design and recorded evidenceRegulatory decision evidence
- Fixation, Vision Training, Binocular (NXR) — FDA decisions, comparisons and evidenceFDA record research
- Fixed Patient Leads ECG Cable (Model 3153) (K172591): indications, design and recorded evidenceRegulatory decision evidence
- Fixone Biocomposite Anchor (K230892): indications, design and recorded evidenceRegulatory decision evidence
- Fixone Biocomposite Small Anchor (K192032): indications, design and recorded evidenceRegulatory decision evidence
- Fixone hybrid knotless anchor (K203523): indications, design and recorded evidenceRegulatory decision evidence
- Fixtemp® C&B 4:1 (K241226): indications, design and recorded evidenceRegulatory decision evidence
- FixxSure® X-Link (K162143): indications, design and recorded evidenceRegulatory decision evidence
- Flat Panel Detector (K201591): indications, design and recorded evidenceRegulatory decision evidence
- Flex Body SPEEDER (K193140): indications, design and recorded evidenceRegulatory decision evidence
- Flex Body Speeder (K200477): indications, design and recorded evidenceRegulatory decision evidence
- FlexBoardTM, EagleBoardTM, BreastBoard SXTM (K213439): indications, design and recorded evidenceRegulatory decision evidence
- FlexCath Advance Steerable Sheath and Dilator (K183174): indications, design and recorded evidenceRegulatory decision evidence
- FlexCath Advance Steerable Sheath and Dilator (K202620): indications, design and recorded evidenceRegulatory decision evidence
- FlexPointer 1.5 Single Use, FlexTube 3 Single Use (K200041): indications, design and recorded evidenceRegulatory decision evidence
- Flexi-Seal PROTECT Fecal Management System (K162906): indications, design and recorded evidenceRegulatory decision evidence
- Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) (K190114): indications, design and recorded evidenceRegulatory decision evidence
- Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) (K222162): indications, design and recorded evidenceRegulatory decision evidence
- Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US) (K222737): indications, design and recorded evidenceRegulatory decision evidence
- Flexible Video-Uretero-Choledochoscope System (K142556): indications, design and recorded evidenceRegulatory decision evidence
- Flexicare Heated Wire Breathing Systems (K150900): indications, design and recorded evidenceRegulatory decision evidence
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