Medicor USA, Ltd.
Mchenry, IL, US
Medicor USA , Ltd. appears in FDA device records in Mchenry, IL. FDA records list 14 510(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
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Medicor USA, Ltd. between 1978 and 1986. The busiest year on record is 1984, with 4. The most recent is 1986, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1979 | 2 |
| 1983 | 1 |
| 1984 | 4 |
| 1985 | 3 |
| 1986 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K861994 | MODEL RS-3I RADIOGRAPHIC/FLUROSCOPIC X-RAY SYSTEM | KPR | Substantially Equivalent | |
| K861995 | MODEL RS-3 RADIOGRAPHIC STAND | IYB | Substantially Equivalent | |
| K860025 | MODEL MS-325 RADIOGRAPHIC X-RAY GENERATOR | KPR | Substantially Equivalent | |
| K850761 | MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C | BZN | Substantially Equivalent | |
| K851358 | MODEL BION 2/TYPE 90 ROOM IONIZER | FRF | Substantially Equivalent | |
| K851094 | MODEL BION 1/TYPE 1084T CAR IONIZER | FRF | Substantially Equivalent | |
| K843335 | FLOOR MOUNTED X-RAY TUBESTAND | IYB | Substantially Equivalent | |
| K840227 | UROLIX-3 UROLOGICAL TABLE | IXR | Substantially Equivalent | |
| K840225 | C-ARM CEILING CRANE FT-2 | JAA | Substantially Equivalent | |
| K840226 | MOTOR TILTED EXAM. TABLE UV-56 | IXR | Substantially Equivalent | |
| K823695 | CPM METABOLIC MONITOR | BZL | Substantially Equivalent | |
| K791287 | MEDICOR QUALITY CONTROL BUFFER | JJS | Substantially Equivalent | |
| K790803 | SYRINGE TONOMETER | Substantially Equivalent | ||
| K781417 | PRECISION GAS MIXER | LCH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)
- FRFCleaner, Air, Medical Recirculating
- BZLComputer, Oxygen-Uptake
- JJSControls For Blood-Gases, (Assayed And Unassayed)
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- KPRSystem, X-Ray, Stationary
- IXRTable, Radiographic, Tilting
- LCHTonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical
- IYBTube Mount, X-Ray, Diagnostic
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