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

Warrensville Heights, OH, US

FERTILITY SOLUTIONS, INC. appears in FDA device records in Warrensville Heights, OH. FDA records list one 510(k) clearance, 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
1
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Fertility Solutions, Inc. in 2004.

Clearances by year, as a table
510(k) clearance decisions for Fertility Solutions, Inc., by decision year
YearClearances
20041
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K041240SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYEDNRFSubstantially Equivalent

Registered establishments

FDA registered establishments for Fertility Solutions, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30037505103003750510FERTILITY SOLUTIONS, INC.4635 Richmond Road, Warrensville Heights, OH 44128 US2026

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