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

Stuart, FL, US

LINEAGE BIOMEDICAL, INC appears in FDA device records in Stuart, FL. 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 Lineage Biomedical, Inc in 2023.

Clearances by year, as a table
510(k) clearance decisions for Lineage Biomedical, Inc, by decision year
YearClearances
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K231877NavaClick Injection SystemFMFSubstantially Equivalent

Registered establishments

FDA registered establishments for Lineage Biomedical, Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30302014893030201489LINEAGE BIOMEDICAL, INC620 NW Dixie Hwy, Stuart, FL 34994 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-2535-2024NavaClick Syringe and Needle, Model Number LIN02Incorrect GTIN number on carton.Class IIIOpen, Classified

Verification record

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