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

Heath, OH, US

KLARITY MEDICAL PRODUCTS, LLC appears in FDA device records in Heath, 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 Klarity Medical Products LLC in 2013.

Clearances by year, as a table
510(k) clearance decisions for Klarity Medical Products LLC, by decision year
YearClearances
20131
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K132124KLARITY VACUUM BAG, KLARITY MOLD CUSHIONIYESubstantially Equivalent

Registered establishments

FDA registered establishments for Klarity Medical Products LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
15305613001236129KLARITY MEDICAL PRODUCTS, LLC600 Industrial Pkwy, Heath, OH 43056 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-2881-2020Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC, RC7221-25BC, RC7504-17.5C - Product Usage: To be used by trained medical professionals for the stable support and positioning of patients undergoing external beam radiation therapy treatment in a clinic or hospital setting.Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times.Class IITerminated

Verification record

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