Company ยท US
Bio Medicus, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 1992. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | 3 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 3 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 2 |
| DPT | Probe, Blood-Flow, Extravascular | 1 |
| DQY | Catheter, Percutaneous | 1 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 1 |
| DWJ | System, Thermal Regulating | 1 |
| DYB | Introducer, Catheter | 1 |
| LIO | Device, Specimen Collection | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 19, 1992 | K920761 | URINE CULTUR STABILIZATION TRANSPORT TUBE Bio Medicus, Inc. | LIO |
| Oct 31, 1990 | K903410 | BIO-MEDICUS CANNULA INTRODUCER Bio Medicus, Inc. | DYB |
| Sep 5, 1990 | K901253 | (PBS) PORTABLE BYPASS SYSTEM, MODEL 1000 Bio Medicus, Inc. | DTZ |
| Jun 28, 1990 | K901584 | BIO-MEDICUS BIO CONSOLE MODELS 540 A B C Bio Medicus, Inc. | DWA |
| Nov 2, 1989 | K894980 | BIO-CAL 370 HEATER/COOLER Bio Medicus, Inc. | DWJ |
| Dec 21, 1988 | K884129 | BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SET Bio Medicus, Inc. | DQY |
| Oct 28, 1988 | K883956 | BIO-MEDICUS TUBING CONNECTORS Bio Medicus, Inc. | DTL |
| Dec 7, 1987 | K872033 | BIO-MEDICUS CANNULA-TUBING Bio Medicus, Inc. | DWF |
| May 21, 1986 | K861096 | CARDIOPULMONARY CANNULA TUBING Bio Medicus, Inc. | DWF |
| Jan 8, 1986 | K854133 | BIO MEDICUS BIO CONSOLE 540 Bio Medicus, Inc. | DWA |
| Oct 11, 1985 | K853126 | BIO PACK MODEL 200 Bio Medicus, Inc. | DWA |
| Sep 30, 1985 | K852807 | BIO MEDICUS BIO PUMP MODEL BP-50 Bio Medicus, Inc. | KFM |
| Sep 30, 1985 | K852698 | BIO MEDICUS BIO PUMP MODEL BP-80 Bio Medicus, Inc. | KFM |
| Jun 19, 1985 | K851855 | BIO MEDICUS BIO PUMP MODEL BP-90 Bio Medicus, Inc. | KFM |
| Jun 8, 1983 | K830858 | BIO-PROBE SYSTEM-BLOOD FLOW PROBE Bio Medicus, Inc. | DPT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||