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

Kitchener Ontario, CA

VENA MEDICAL HOLDINGS CORP. appears in FDA device records in Kitchener Ontario, CA. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. 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
1

510(k) clearance history

FDA records hold 2 510(k) clearances for Vena Medical Holdings Corp. between 2025 and 2026. The busiest year on record is 2025, with 1. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Vena Medical Holdings Corp., by decision year
YearClearances
20251
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253842Vena MicroAngioscope™ SystemLYKSubstantially Equivalent
K251767Vena MicroAngioscope™ SystemLYKSubstantially Equivalent

Registered establishments

FDA registered establishments for Vena Medical Holdings Corp., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30164816193016481619VENA MEDICAL HOLDINGS CORP.809 Wellington Street North, Kitchener Ontario N2H 5L6 CA2026

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

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

MDM coverage

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