Medical Device Manufacturer · US , Santa Barbera , CA

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

14 submissions · 14 cleared · Since 1989

Total

Cleared

Denied

Helix Medical, Inc. has 14 FDA 510(k) cleared ear, nose, throat devices. Based in Santa Barbera, US.

Historical record: 14 cleared submissions from 1989 to 2002.

Browse the complete list of FDA 510(k) cleared ear, nose, throat devices from this manufacturer. Filter by specialty or product code using the sidebar.

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

14 devices

1-12 of 14

Cleared Dec 26, 2002

INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200

K023259 · FDF

Gastroenterology & Urology · 87d

Cleared Jun 25, 1999

BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS

K991587 · EWL

Ear, Nose, Throat · 49d

Cleared Dec 09, 1994

INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE

K945287 · EWL

Ear, Nose, Throat · 39d

Cleared Dec 02, 1994

INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE

K945288 · EWL

Ear, Nose, Throat · 32d

Cleared Apr 15, 1994

BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES

K932120 · EWL

Ear, Nose, Throat · 347d

Cleared Dec 15, 1993

BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET

K932163 · EWL

Ear, Nose, Throat · 225d

Cleared May 17, 1993

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

K930105 · EWL

Ear, Nose, Throat · 126d

Cleared Sep 10, 1992

BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET

K920090 · EWL

Ear, Nose, Throat · 246d

Cleared Jun 30, 1992

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

K915786 · BYD

Anesthesiology · 189d

Cleared Feb 28, 1991

BLOM-SINGER SHOWER GUARD

K904729 · EWL

Ear, Nose, Throat · 134d

Cleared Aug 01, 1990

BLOM-SINGER(R) TRACHEOESOPHAGEAL FISTULA STENT

K902112 · EWL

Ear, Nose, Throat · 84d

Cleared Jun 14, 1990

BLOM-SINGER(R) TRACHEOESOPHAGEAL PUNCTURE KIT

K900518 · EWL

Ear, Nose, Throat · 132d

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

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