R-Med, Inc.
Oregon, OH, US
R-MED, INC. appears in FDA device records in Oregon, OH. FDA records list 9 510(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 9 510(k) clearances for R-Med, Inc. between 1994 and 2000. The busiest year on record is 1995, with 4. The most recent is 2000, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 3 |
| 1995 | 4 |
| 1996 | 1 |
| 2000 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K001236 | RIZA BAND STRETCHER (RBS)-60000 | FHN | Substantially Equivalent | |
| K953360 | R-MED ABDOMINAL WALL ELEVATOR | HET | Substantially Equivalent | |
| K954882 | RIZA-RIBE NEEDLE (MODIFICATION) | HRX | Substantially Equivalent | |
| K953441 | RIZA-RIBE NEEDLE | FBK | Substantially Equivalent | |
| K950108 | R-MED MINI-RETRACTOR | HET | Substantially Equivalent | |
| K942411 | R-MED DISPOSABLE PLUG | HET | Substantially Equivalent | |
| K945637 | R-MED MOTORIZED LAPAROSCOPIC HANDLE | GCJ | Substantially Equivalent | |
| K943818 | MANUAL LAPAROSOPIC HANDLE, INTERCHANGEABLE LAPAROSCOPIC TOOL UNITS | GEI | Substantially Equivalent | |
| K935031 | RIZA-RIBE NEEDLE | HET | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1529233 | 1000305979 | R-MED, INC. | 3465 NAVARRE AVENUE, OREGON, OH 43616 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
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