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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) clearances
12
PMA records
0
Recall records
1
Registered establishments
1

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
510(k) clearance decisions for Med-logics Inc, by decision year
YearClearances
19961
19972
19982
20001
20013
20022
20041
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K033293MED-LOGICS, MODEL ML7090HNOSubstantially Equivalent
K022982MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLBHNOSubstantially Equivalent
K022716MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLBHNOSubstantially Equivalent
K010872ML BLADE, MODEL ML7030HNOSubstantially Equivalent
K010353MED-LOGICS DISPOSABLE ALK TUBINGKYGSubstantially Equivalent
K002515MEDLOGICS ML 4000, MODEL 4000HNOSubstantially Equivalent
K002279ML EYE SPEAR, MODEL ML 27 ESHOZSubstantially Equivalent
K983448ML UNIVERSAL TUBINGMSRSubstantially Equivalent
K981071ML MICROKERATOMEHNOSubstantially Equivalent
K972522ML-DISPOSABLE PAKMSRSubstantially Equivalent
K971173ML DISPOSABLE ALK TUBINGKYGSubstantially Equivalent
K962661ML MICROKERATOME BLADEHNOSubstantially Equivalent

Registered establishments

FDA registered establishments for Med-logics Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
20850811000142667MED-LOGICS, INC.1627 Enterprise St, Athens, TX 75751 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1268-2015ML 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 IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain