510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Cortex Manufacturing, LLC

Byhalia, MS, US

CORTEX MANUFACTURING, LLC appears in FDA device records in Byhalia, MS. FDA records list 3 510(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) clearances
3
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 3 510(k) clearances for Cortex Manufacturing, LLC between 2010 and 2015. The busiest year on record is 2010, with 1. The most recent is 2015, with 1.

Clearances by year, as a table
510(k) clearance decisions for Cortex Manufacturing, LLC, by decision year
YearClearances
20101
20111
20151
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K142294FlexiMarc MarkerIYESubstantially Equivalent
K102506MIXED MEDIA MARKERNEUSubstantially Equivalent
K100267FLEXIMARC, MODEL CM-0.9-2-10-GG-LIYESubstantially Equivalent

Registered establishments

FDA registered establishments for Cortex Manufacturing, LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30087067073008706707CORTEX MANUFACTURING, LLC7753 Highway 72, Byhalia, MS 38611 US2026

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

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