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

Cincinnati, OH, US

Elite Biomedical Solutions LLC appears in FDA device records in Cincinnati, OH. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 2 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
2
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Elite Biomedical Solutions LLC in 2022.

Clearances by year, as a table
510(k) clearance decisions for Elite Biomedical Solutions LLC, by decision year
YearClearances
20221
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K220695Elite Biomedical Solutions Dose Request CordMRZSubstantially Equivalent

Registered establishments

FDA registered establishments for Elite Biomedical Solutions LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30097121133009712113Elite Biomedical Solutions LLC756 CINCINNATI BATAVIA PIKE STE C, Cincinnati, OH 45245 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-2372-2015Alaris Medley LVP Bezel Assembly. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.Class ITerminated
Z-2371-2015Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.Class ITerminated

Verification record

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