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

Grand Rapids, MI, US

RANIR LLC appears in FDA device records in Grand Rapids, MI. FDA records list 2 510(k) clearances between and , 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
2
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for Ranir LLC between 2006 and 2013. The busiest year on record is 2006, with 1. The most recent is 2013, with 1.

Clearances by year, as a table
510(k) clearance decisions for Ranir LLC, by decision year
YearClearances
20061
20131
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K133423REST ASSURED EXTRA COMFORT NITE PROTECTOROBRSubstantially Equivalent
K063229REST ASSURED NITE PROTECTOROBRSubstantially Equivalent

Registered establishments

FDA registered establishments for Ranir LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
18256601825660RANIR LLC4701 E PARIS AVE SE, Grand Rapids, MI 49512 US2026and 4 more, listed in full below

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-0782-2014UP & UP kids' power toothbrushRanir, LLC is recalling all lots of UP & UP brand Kid's Power Toothbrush and TopCare brand Clifford Kids Power Toothbrush because the tufted disk may become detached from the power brush handle. If the tuft retention disk detaches from the handle, it is a potential choking hazard for children three years old and younger.Class IITerminated
Z-0781-2014TopCare Clifford THE BIG RED DOG power toothbrush for kids!Ranir, LLC is recalling all lots of Up & Up brand Kid's Power Toothbrush and TopCare brand Clifford Kids Power Toothbrush because the tufted disk may become detached from the power brush handle. If the tuft retention disk detaches from the handle, it is a potential choking hazard for children three years old and younger.Class IITerminated

Verification record

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