Medical Device Manufacturer · US , Carpinteria , CA

Helix Medical, LLC - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2008
4
Total
4
Cleared
0
Denied

Helix Medical, LLC — FDA 510(k) Products and Clearance History Ear, Nose, Throat ✕

4 devices
1-4 of 4
Cleared Dec 17, 2013
BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS
K130736 · LRC
Ear, Nose, Throat · 274d
Cleared Sep 17, 2013
BLOM-SINGER SEPTAL PERFORATION PROSTHESIS
K131745 · LFB
Ear, Nose, Throat · 96d
Cleared Mar 03, 2010
BLOM-SINGER INDWELLING TEP OCCLUDER
K093258 · EWL
Ear, Nose, Throat · 135d
Cleared Sep 04, 2008
BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES,...
K082206 · EWL
Ear, Nose, Throat · 30d
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