Bio Medicus, Inc.
Mchenry, IL, US
Bio Medicus, Inc. appears in FDA device records in Mchenry, IL. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Bio Medicus, Inc. between 1983 and 1992. The busiest year on record is 1985, with 4. The most recent is 1992, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1985 | 4 |
| 1986 | 2 |
| 1987 | 1 |
| 1988 | 2 |
| 1989 | 1 |
| 1990 | 3 |
| 1992 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K920761 | URINE CULTUR STABILIZATION TRANSPORT TUBE | LIO | Substantially Equivalent | |
| K903410 | BIO-MEDICUS CANNULA INTRODUCER | DYB | Substantially Equivalent | |
| K901253 | (PBS) PORTABLE BYPASS SYSTEM, MODEL 1000 | DTZ | Substantially Equivalent | |
| K901584 | BIO-MEDICUS BIO CONSOLE MODELS 540 A B C | DWA | Substantially Equivalent | |
| K894980 | BIO-CAL 370 HEATER/COOLER | DWJ | Substantially Equivalent | |
| K884129 | BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SET | DQY | Substantially Equivalent | |
| K883956 | BIO-MEDICUS TUBING CONNECTORS | DTL | Substantially Equivalent | |
| K872033 | BIO-MEDICUS CANNULA-TUBING | DWF | Substantially Equivalent | |
| K861096 | CARDIOPULMONARY CANNULA TUBING | DWF | Substantially Equivalent | |
| K854133 | BIO MEDICUS BIO CONSOLE 540 | DWA | Substantially Equivalent | |
| K853126 | BIO PACK MODEL 200 | DWA | Substantially Equivalent | |
| K852807 | BIO MEDICUS BIO PUMP MODEL BP-50 | KFM | Substantially Equivalent | |
| K852698 | BIO MEDICUS BIO PUMP MODEL BP-80 | KFM | Substantially Equivalent | |
| K851855 | BIO MEDICUS BIO PUMP MODEL BP-90 | KFM | Substantially Equivalent | |
| K830858 | BIO-PROBE SYSTEM-BLOOD FLOW PROBE | DPT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- DQYCatheter, Percutaneous
- DWAControl, Pump Speed, Cardiopulmonary Bypass
- LIODevice, Specimen Collection
- DYBIntroducer, Catheter
- DTZOxygenator, Cardiopulmonary Bypass
- DPTProbe, Blood-Flow, Extravascular
- KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- DWJSystem, Thermal Regulating
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain