Medical Device Manufacturer · US , Temecula , CA

Galemed Corp. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2002

Recent clearances: AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER, DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE, GIO DIGITAL PRESSURE GUAGES

View 7 510(k) Devices ↓

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Galemed Corp. Anesthesiology ✕

6 devices

1-6 of 6

Cleared Apr 14, 2014

DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE

Anesthesiology · 112d

Cleared Aug 22, 2013

GIO DIGITAL PRESSURE GUAGES

Anesthesiology · 359d

Cleared Oct 15, 2008

DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE...

Anesthesiology · 83d

Cleared Nov 16, 2007

GALEMED CPAP MASK

Anesthesiology · 50d

Cleared Apr 03, 2003

GALEMED PEAK FLOW METER, MODELS 3751/3752

Anesthesiology · 276d

Cleared Oct 25, 2002

GALEMED NEB-EASY NEBULIZER

Anesthesiology · 150d