Biomedix, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
11
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0023-2015Class IIBiomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿ and LDPE/PET pouch. SeAugust 14, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K142097SELEC-3 I.V.ADMINISTRATION SETAugust 29, 2014
K122281PADNET 2.0August 29, 2012
K073146PADNET+November 21, 2007
K050182Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEMAugust 9, 2005
K042616BIOMEDIX PADNET LABOctober 12, 2004
K033627Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEMMay 21, 2004
K973857FLOSTAT VASCULAR REPORT GENERATOR (VRG)December 29, 1997
K973644FLOSTAT VASCULAR LABDecember 23, 1997
K961928BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102September 16, 1996
K925645SELEC-3September 27, 1993
K926498ENDOGRIPApril 7, 1993