Helix Medical, LLC - FDA 510(k) Cleared Devices
Recent clearances: BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS, BLOM-SINGER SEPTAL PERFORATION PROSTHESIS, BLOM-SINGER INDWELLING TEP OCCLUDER
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Helix Medical, LLC Ear, Nose, Throat ✕
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