Biomedix, Inc.
FDA Regulatory Profile
Biomedix, Inc. appears in FDA public data with 1 recall, 11 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0023-2015, Class II) was initiated on August 14, 2014. Its most recent 510(k) clearance was granted on August 29, 2014.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 11
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0023-2015 | Class II | Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿ and LDPE/PET pouch. Se | August 14, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K142097 | SELEC-3 I.V.ADMINISTRATION SET | August 29, 2014 |
| K122281 | PADNET 2.0 | August 29, 2012 |
| K073146 | PADNET+ | November 21, 2007 |
| K050182 | Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM | August 9, 2005 |
| K042616 | BIOMEDIX PADNET LAB | October 12, 2004 |
| K033627 | Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM | May 21, 2004 |
| K973857 | FLOSTAT VASCULAR REPORT GENERATOR (VRG) | December 29, 1997 |
| K973644 | FLOSTAT VASCULAR LAB | December 23, 1997 |
| K961928 | BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102 | September 16, 1996 |
| K925645 | SELEC-3 | September 27, 1993 |
| K926498 | ENDOGRIP | April 7, 1993 |