Medical Device Manufacturer · US , Santa Barbera , CA

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

14 submissions · 14 cleared · Since 1989

14

Total

14

Cleared

0

Denied

FDA 510(k) Regulatory Record - Helix Medical, Inc. Ear, Nose, Throat ✕

10 devices

1-10 of 10

Cleared Jun 25, 1999

BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS

Ear, Nose, Throat · 49d

Cleared Dec 09, 1994

INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE

Ear, Nose, Throat · 39d

Cleared Dec 02, 1994

INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE

Ear, Nose, Throat · 32d

Cleared Apr 15, 1994

BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES

Ear, Nose, Throat · 347d

Cleared Dec 15, 1993

BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET

Ear, Nose, Throat · 225d

Cleared May 17, 1993

BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S.

Ear, Nose, Throat · 126d

Cleared Sep 10, 1992

BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET

Ear, Nose, Throat · 246d

Cleared Feb 28, 1991

BLOM-SINGER SHOWER GUARD

Ear, Nose, Throat · 134d

Cleared Aug 01, 1990

BLOM-SINGER(R) TRACHEOESOPHAGEAL FISTULA STENT

Ear, Nose, Throat · 84d

Cleared Jun 14, 1990

BLOM-SINGER(R) TRACHEOESOPHAGEAL PUNCTURE KIT

Ear, Nose, Throat · 132d