Med-logics Inc
Athens, TX, US
MED-LOGICS, INC. appears in FDA device records in Athens, TX. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for Med-logics Inc between 1996 and 2004. The busiest year on record is 2001, with 3. The most recent is 2004, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 1997 | 2 |
| 1998 | 2 |
| 2000 | 1 |
| 2001 | 3 |
| 2002 | 2 |
| 2004 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K033293 | MED-LOGICS, MODEL ML7090 | HNO | Substantially Equivalent | |
| K022982 | MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB | HNO | Substantially Equivalent | |
| K022716 | MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB | HNO | Substantially Equivalent | |
| K010872 | ML BLADE, MODEL ML7030 | HNO | Substantially Equivalent | |
| K010353 | MED-LOGICS DISPOSABLE ALK TUBING | KYG | Substantially Equivalent | |
| K002515 | MEDLOGICS ML 4000, MODEL 4000 | HNO | Substantially Equivalent | |
| K002279 | ML EYE SPEAR, MODEL ML 27 ES | HOZ | Substantially Equivalent | |
| K983448 | ML UNIVERSAL TUBING | MSR | Substantially Equivalent | |
| K981071 | ML MICROKERATOME | HNO | Substantially Equivalent | |
| K972522 | ML-DISPOSABLE PAK | MSR | Substantially Equivalent | |
| K971173 | ML DISPOSABLE ALK TUBING | KYG | Substantially Equivalent | |
| K962661 | ML MICROKERATOME BLADE | HNO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2085081 | 1000142667 | MED-LOGICS, INC. | 1627 Enterprise St, Athens, TX 75751 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1268-2015 | ML 7090 Calibrated LASIK Blade (CLB); CLB CALIBRATED LASIK BLADE 10. ML 7090 Calibrated LASIK Blade (CLB) is to be used as replacement blades for the AMO Amadeus Microkeratome, to perform lamellar keratectomy procedures. | The ML 7090 Calibrated LASIK Blade (CLB) will not fit into the AMO Amadeus Metal Blade Holder. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain
