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

Mchenry, IL, US

Kingswood Laboratories, Inc. appears in FDA device records in Mchenry, IL. FDA records list 3 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

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

510(k) clearance history

FDA records hold 3 510(k) clearances for Kingswood Laboratories, Inc. between 1981 and 1985. The busiest year on record is 1981, with 1. The most recent is 1985, with 1.

Clearances by year, as a table
510(k) clearance decisions for Kingswood Laboratories, Inc., by decision year
YearClearances
19811
19841
19851
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K851026MOI-STIR ORAL SWABSTICK(S)LFDSubstantially Equivalent
K840807THROAT MOI-STIRLFDSubstantially Equivalent
K810157MOI-STIRLFDSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0820-05Moi-Stir oral swabsticks, an aid to mouth care and oral hygiene, CONTENTS: 3 fibre-tipped swabsticks premoistened with MOI-STIR mouth moistening solutioon and saliva supplement; Product Nos. 55299-703-03 and 55299-703-25. Distributed by Kingswood Laboratories, Inc., Indianapolis, IN 46256-3316. Swabs are sold only in case quantities of 25 foil packs to the carton and 100 foil packs to the case.Contaminated with Aspergillus and Penicillum molds.Terminated

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