International Biophysics Corp.
FDA Regulatory Profile
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 11
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2423-2015 | Class II | IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, C | August 7, 2015 |
| Z-2422-2015 | Class II | IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blo | August 7, 2015 |
| Z-2424-2015 | Class II | IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: | August 7, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K072688 | LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000 | January 11, 2008 |
| K030181 | INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM | April 17, 2003 |
| K992657 | IBC VRV, MODEL 1350 | February 18, 2000 |
| K992785 | IBC FLOGUARD, MODEL 6050 | January 14, 2000 |
| K992964 | IBC VENT VALVE, MODEL 1400 | November 19, 1999 |
| K983272 | IBC FLOPUMP, MODEL 6000 | March 24, 1999 |
| K963703 | ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000) | April 8, 1998 |
| K963756 | IBC CARDIAC SUCTION WARD | November 14, 1997 |
| K963698 | CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 | March 20, 1997 |
| K955379 | IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4) | May 14, 1996 |
| K955380 | IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4) | May 14, 1996 |