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

Ferndale, MI, US

FERNDALE LABORATORIES, INC. appears in FDA device records in Ferndale, MI. 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 Ferndale Laboratories, Inc. in 2007.

Clearances by year, as a table
510(k) clearance decisions for Ferndale Laboratories, Inc., by decision year
YearClearances
20071
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K060272LOCOBASE WOUND AND SKIN EMULSIONFROSubstantially Equivalent

Registered establishments

FDA registered establishments for Ferndale Laboratories, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
18112121811212FERNDALE LABORATORIES, INC.780 W 8 Mile Rd, Ferndale, MI 48220 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-1005-2026Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description: Liquid adhesive, 2/3 mL vial, 48 vials per carton Component: NoButyrate tube cracks during actuation, rendering product unusable.Class IIOpen, Classified
Z-0413-2011Detachol adhesive remover, 4 fl oz (118 mL), Marketed by Eloquest Healthcare, Inc., a Ferndale Pharma Group company, Manufactured by Ferndale Laboratories, Inc., Ferndale, MI 48220 U.S.A.There is a defect on the neck surface of the bottles, causing bottles to leak. Bottle defect may potentially cause contamination of solvent stored in bottles.Terminated

Verification record

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