Medical Device Manufacturer · US , Walker , MI

Portex, Inc. - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 1977

20

Total

20

Cleared

0

Denied

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

14 devices

1-12 of 14

Cleared Mar 10, 2004

PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER

Anesthesiology · 163d

Cleared Jul 18, 2003

PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT

Anesthesiology · 106d

Cleared Feb 11, 2003

1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR

Anesthesiology · 90d

Cleared Feb 27, 2002

1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX

Anesthesiology · 75d

Cleared Jan 19, 1988

THERMOVENT 600, 1200, T, 02

Anesthesiology · 71d

Cleared Aug 06, 1986

Anesthesiology · 58d

Cleared Feb 04, 1984

Anesthesiology · 82d

Cleared Jan 17, 1984

ENDOBRONCHIAL TWIN LUMEN TUBE

Anesthesiology · 20d

Cleared Jan 17, 1984

SWIVEL ADAPTOR W/ALARM PORT

Anesthesiology · 13d

Cleared Aug 12, 1983

CARDIO-ESOPHASCOPE

Anesthesiology · 157d

Cleared Mar 08, 1983

REINFORCED SILICONE TRACHEAL TUBE

Anesthesiology · 33d

Cleared Feb 05, 1981

ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE

Anesthesiology · 15d