Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 71
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- EnCor EnspireBreast Biopsy System (E4115, E4230); EnCor Breast Biopsy Driver (DRENCOR); EnCor MRI Breast Biopsy Driver (DRENCORMR); EnCor Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT) (K233220): indications, design and recorded evidenceRegulatory decision evidence
- EnCor MRI Introducer Set, EnCor Probe Introducer (K161805): indications, design and recorded evidenceRegulatory decision evidence
- Endo Keeper (K152598): indications, design and recorded evidenceRegulatory decision evidence
- Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) (K242514): indications, design and recorded evidenceRegulatory decision evidence
- EndoClot (K190677): indications, design and recorded evidenceRegulatory decision evidence
- EndoDrill® Model X (K212423): indications, design and recorded evidenceRegulatory decision evidence
- EndoFLIP® System with FLIP Topography module (K170833): indications, design and recorded evidenceRegulatory decision evidence
- EndoFixTissue Fixation System (K251229): indications, design and recorded evidenceRegulatory decision evidence
- EndoGI S-Path Biliary Stent System (K222627): indications, design and recorded evidenceRegulatory decision evidence
- EndoGI S-Path Biliary Stent System (K232596): indications, design and recorded evidenceRegulatory decision evidence
- EndoPATx (K211557): indications, design and recorded evidenceRegulatory decision evidence
- EndoScreener (K211326): indications, design and recorded evidenceRegulatory decision evidence
- EndoSign® Cell collection device (ES-CYT-102) (K233142): indications, design and recorded evidenceRegulatory decision evidence
- EndoVac Pure (K162436): indications, design and recorded evidenceRegulatory decision evidence
- Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 (K201832): indications, design and recorded evidenceRegulatory decision evidence
- EndoflipTM 300 (K223705): indications, design and recorded evidenceRegulatory decision evidence
- Endoform Reconstructive Template - Non Absorbable (K181935): indications, design and recorded evidenceRegulatory decision evidence
- Endoform Topical Matrix (K171231): indications, design and recorded evidenceRegulatory decision evidence
- Endomina EZFuse system (K252400): indications, design and recorded evidenceRegulatory decision evidence
- Endorail (K232327): indications, design and recorded evidenceRegulatory decision evidence
- Endoscope Channel Accessory (ODC) — FDA decisions, comparisons and evidenceFDA record research
- Endoscope Model EG-580UT and Endoscope Model EG-580UR (K221952): indications, design and recorded evidenceRegulatory decision evidence
- Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D (K223295): indications, design and recorded evidenceRegulatory decision evidence
- Endoscope, Accessories, Narrow Band Spectrum (NWB) — FDA decisions, comparisons and evidenceFDA record research
- Endoscopic Access Overtube, Gastroenterology-Urology (FED) — FDA decisions, comparisons and evidenceFDA record research
Page 71 of 228