Medical Device Manufacturer · US , Santa Barbera , CA

Helix Medical, Inc. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 1989

Recent clearances: INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200, BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS, INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE

View 14 510(k) Devices ↓

14

Total

14

Cleared

0

Denied

FDA 510(k) Regulatory Record - Helix Medical, Inc. Anesthesiology ✕

2 devices

1-2 of 2

Cleared Jun 30, 1992

BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID.

Anesthesiology · 189d

Cleared Mar 16, 1990

BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE

Anesthesiology · 88d