Cruxi research & evidence

FDA 510(k) Submission Services evidence guides — page 181

Compare documented facts, dated analyses and evidence that can change your project scope. Confirm applicability with a specialist.

• Sim&Size (K212373): indications, design and recorded evidenceRegulatory decision evidence
• Sim&Size (K222664): indications, design and recorded evidenceRegulatory decision evidence
• Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings (QWR) — FDA decisions, comparisons and evidenceFDA record research
• SimpleSENSE Platform (K212160): indications, design and recorded evidenceRegulatory decision evidence
• SimpleStitch Suturing System (K243750): indications, design and recorded evidenceRegulatory decision evidence
• Single Lumen Ecmo Cannula (QHW) — FDA decisions, comparisons and evidenceFDA record research
• Single Lumen Ovum Aspiration Needles (K171625): indications, design and recorded evidenceRegulatory decision evidence
• Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) (K252889): indications, design and recorded evidenceRegulatory decision evidence
• Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) (K251664): indications, design and recorded evidenceRegulatory decision evidence
• Single Use Aspiration Needle (K190239): indications, design and recorded evidenceRegulatory decision evidence
• Single Use Aspiration Needle NA-U200H (K151738): indications, design and recorded evidenceRegulatory decision evidence
• Single Use Aspiration Needle NA-U401SX (K160098): indications, design and recorded evidenceRegulatory decision evidence
• Single Use Balloon Dilator V (with knife) (K193039): indications, design and recorded evidenceRegulatory decision evidence
• Single Use Biliary Balloon Dilator (K143303): indications, design and recorded evidenceRegulatory decision evidence
• Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) (K250351): indications, design and recorded evidenceRegulatory decision evidence
• Single Use Electrosurgical knife (K171158): indications, design and recorded evidenceRegulatory decision evidence
• Single Use Grasping Forceps (K191900): indications, design and recorded evidenceRegulatory decision evidence
• Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804L (K200342): indications, design and recorded evidenceRegulatory decision evidence
• Single Use Hemoclip (K172762): indications, design and recorded evidenceRegulatory decision evidence
• Single Use Hemoclip (K212669): indications, design and recorded evidenceRegulatory decision evidence
• Single Use Hot Biopsy Forceps FD-231 (K171916): indications, design and recorded evidenceRegulatory decision evidence
• Single Use Hot Biopsy Forceps FD-231 (K173495): indications, design and recorded evidenceRegulatory decision evidence
• Single Use Injection Needle (K210917): indications, design and recorded evidenceRegulatory decision evidence
• Single Use Injector (K192498): indications, design and recorded evidenceRegulatory decision evidence
• Single Use Injector NM600/610 (K153625): indications, design and recorded evidenceRegulatory decision evidence

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