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

Halifax Nova Scotia, CA

ABK BIOMEDICAL appears in FDA device records in Halifax Nova Scotia, CA. FDA records list 2 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no 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
0
Registered establishments
2

510(k) clearance history

FDA records hold 2 510(k) clearances for Abk Biomedical between 2022 and 2024. The busiest year on record is 2022, with 1. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Abk Biomedical, by decision year
YearClearances
20221
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K234123Easi-Vue® embolic microspheres SystemKRDSubstantially Equivalent
K220567Easi-Vue embolic microspheres SystemKRDSubstantially Equivalent

Registered establishments

FDA registered establishments for Abk Biomedical, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30135052213013505221ABK BIOMEDICAL155 Chain Lake Drive, Halifax Nova Scotia B3S 1B3 CA2026
30200934473020093447ABK BIOMEDICAL43 Charles Street, Needham, MA 02494 US2026No device listings on this registration

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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