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Saluda Medical

Bloomington, MN, US

Saluda Medical appears in FDA device records in Bloomington, MN. FDA records list no 510(k) clearances, 43 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
0
PMA records
43
Recall records
0
Registered establishments
2

510(k) clearance history

No 510(k) clearance records for this company in the ingested FDA data.

No 510(k) clearance records in the ingested FDA data.

Registered establishments

FDA registered establishments for Saluda Medical, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30161111363016111136Saluda Medical9401 James Ave S, Bloomington, MN 55431 US2026No device listings on this registration
30218363093021836309Saluda Medical Pty. Ltd.5 Eden Park Drive, Macquarie Park New South Wales 2113 AU2026

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

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