Medical Concepts
Temecula, CA, US
MEDICAL CONCEPTS appears in FDA device records in Temecula, CA. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Medical Concepts between 1980 and 2011. The busiest year on record is 1988, with 2. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1988 | 2 |
| 1994 | 1 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K110659 | MEDICAL CONCEPTS INTERBODY FUSION SYSTEM | MAX | Substantially Equivalent | |
| K940283 | KARL STORZ ENDOVISION UROCAM/HYSTEROCAM | FET | Substantially Equivalent | |
| K883944 | MEC-1 VIDEO COMBO SYSTEM | FTS | Substantially Equivalent | |
| K883943 | CCM-1 VIDEO CAMERA SYSTEM | FTS | Substantially Equivalent | |
| K802564 | MEDICAL MAGNETIC TAPE RECORDER | DSH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2951117 | 1000161196 | MEDICAL CONCEPTS | 27570 Commerce Center Dr Suite 115, Temecula, CA 92590 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FTSCamera, Cine, Endoscopic, With Audio
- KESCoverslips, Microscope Slide
- MHWDressing, Compression
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- DSHRecorder, Magnetic Tape, Medical
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain