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

Brooklyn, OH, US

Superior Products, LLC appears in FDA device records in Brooklyn, OH. FDA records list one 510(k) clearance, 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
1
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Superior Products, LLC in 2005.

Clearances by year, as a table
510(k) clearance decisions for Superior Products, LLC, by decision year
YearClearances
20051
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K051988OXY-SERVE II OXYGEN CONSERVING REGULATORNFBSubstantially Equivalent

Registered establishments

FDA registered establishments for Superior Products, LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
15299891000515374Superior Products, LLC3786 RIDGE RD., Brooklyn, OH 44144 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-0529-2008Oxy Serve II Oxygen Conserving Regulator, Model Number: MCRB-870-6, Superior Products, Inc/SP Medical, LLC, Cleveland, Ohio 44144Leakage: Device was leaking oxygenTerminated

Verification record

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