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

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
1-14 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
Cleared Mar 16, 1990
BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE
K897005 · JOH
Anesthesiology · 88d
Cleared Aug 24, 1989
HOUTS HYSTERECTOMY DRAIN
K894220 · GBW
General & Plastic Surgery · 66d
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