Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Helix Medical, LLC

FDA 510(k) & PMA Approved Devices — 4 products

Total Devices4
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K130736 BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESISLRC2013-12-17 View
510(k) K131745 BLOM-SINGER SEPTAL PERFORATION PROSTHESISLFB2013-09-17 View
510(k) K093258 BLOM-SINGER INDWELLING TEP OCCLUDEREWL2010-03-03 View
510(k) K082206 BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIESEWL2008-09-04 View
↑