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

Dallas, TX, US

BIOMED LABORATORIES LLC appears in FDA device records in Dallas, TX. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
3
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Biomed Laboratories LLC in 2011.

Clearances by year, as a table
510(k) clearance decisions for Biomed Laboratories LLC, by decision year
YearClearances
20111
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K100613BIOMED WOUND CLEANSERFROSubstantially Equivalent

Registered establishments

FDA registered establishments for Biomed Laboratories LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30067849483006784948BIOMED LABORATORIES LLC8181 Eastpoint Drive, Dallas, TX 75227 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-2428-2010Safen' simple Ostomy Appliance Deodorant (8 oz , 1 oz package sizes)The product may contain the mold Aspergillus ssp.Terminated
Z-2427-2010Genairex Securi-T Ostomy Deodorant (8 oz, 1 oz package sizes)The product may contain the mold Aspergillus ssp.Terminated
Z-2426-2010Reliamed Odor Eliminator Drops (8 oz, 4 oz, 1 oz package sizes)The product may contain the mold Aspergillus ssp.Terminated

Verification record

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