Gibeck, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K965016ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)December 2, 1997
K964377THERMAL REGULATION SYSTEM BLANKETApril 23, 1997
K964382HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)April 15, 1997
K960511GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKETJanuary 13, 1997
K954828ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORTMay 2, 1996
K953544HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHTAugust 25, 1995
K953491HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLEAugust 25, 1995
K952845HUMID-VENT TRACH-VENTJuly 25, 1995
K952750HUMID-VENT 1July 20, 1995
K952844HUMID-VENT 2July 20, 1995
K952084HUMID-VENT FILTER PEDIJune 12, 1995
K951856HUMID-VENT MICROJune 7, 1995
K914747XENON CIRCUITFebruary 27, 1992
K900979GAS SAMPLING NASAL CANNULAMarch 16, 1990
K897171DISPOSABLE CO2 ABSORBER/EMarch 13, 1990