Medtronic Bio-Medicus, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 13
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K973237 | CSS-CARDIOPLEGIA SAFETY SYSTEM | April 27, 1998 |
| K973011 | BPX80 BIO-PUMP (BPX80) | February 25, 1998 |
| K954501 | BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM | January 16, 1996 |
| K941922 | MEDSAT OXYGEN SATURATION SYSTEM | February 17, 1995 |
| K936091 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER | December 23, 1994 |
| K941921 | BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550 | July 20, 1994 |
| K924208 | BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P) | July 8, 1993 |
| K926357 | MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150 | June 2, 1993 |
| K924206 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E | May 7, 1993 |
| K924205 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550 | May 6, 1993 |
| K924642 | MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER | March 26, 1993 |
| K924643 | MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT | December 8, 1992 |
| K914754 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540-D | May 20, 1992 |