Helix Medical, LLC is one of 5145 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Helix Medical, LLC - FDA 510(k) Cleared Devices
4
Total
4
Cleared
0
Denied
Helix Medical, LLC has 4 FDA 510(k) cleared medical devices. Based in Carpinteria, US.
Historical record: 4 cleared submissions from 2008 to 2013. Primary specialty: Ear, Nose, Throat.
Browse the FDA 510(k) cleared devices submitted by Helix Medical, LLC Filter by specialty or product code using the sidebar.
Helix Medical, LLC — FDA 510(k) Products and Clearance History
4 devices
Cleared
Dec 17, 2013
BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS
Ear, Nose, Throat
274d
Cleared
Sep 17, 2013
BLOM-SINGER SEPTAL PERFORATION PROSTHESIS
Ear, Nose, Throat
96d
Cleared
Mar 03, 2010
BLOM-SINGER INDWELLING TEP OCCLUDER
Ear, Nose, Throat
135d
Cleared
Sep 04, 2008
BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES,...
Ear, Nose, Throat
30d