Cobe Laboratories, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 77
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K923272 | COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR | May 11, 1993 |
| K900105 | COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC | March 22, 1991 |
| K905793 | COBE CENTRY 2 BICART OPTION KIT | February 12, 1991 |
| K905388 | COBE CENTRYSYSTEM 3 BICART OPTION KIT | February 11, 1991 |
| K904336 | NEW COBE SATURATION/HEMATOCRIT MONITOR | December 27, 1990 |
| K902437 | COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER | December 17, 1990 |
| K902631 | COBE ICU CONVERSION KIT | December 17, 1990 |
| K904566 | NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER | December 12, 1990 |
| K902758 | COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC | August 23, 1990 |
| K902759 | COBE CLOSED WOUND DRAINAGE KIT | July 18, 1990 |
| K902671 | COBE AUTOLOGOUS BLOOD SALVAGE RESERV W/W/O FILTER | July 17, 1990 |
| K900910 | COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) | May 22, 1990 |
| K900758 | HEPARINIZED ARTERIAL SCREEN BLOOD FILTER | May 17, 1990 |
| K895076 | CMS VRB-1200 | November 3, 1989 |
| K893962 | COBE 2991 SUPPLEMENTARY DISPOSABLE SETS | October 18, 1989 |
| K881811 | COBE CENTRYSYSTEM HOLLOW FIBER DIALYZERS | September 15, 1988 |
| K881330 | COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK | June 10, 1988 |
| K881062 | CENTRY 2 ULTRAFILTRATION CONTROL KIT, #018762-002 | April 21, 1988 |
| K880021 | COBE CML3 | April 1, 1988 |
| K870976 | ONGUARD 1000, CATALOG #043611-000 & 043611-001 | May 6, 1987 |