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

Smithfield, PA, US

BERKLEY MEDICAL RESOURCES, INC. appears in FDA device records in Smithfield, PA. 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 Berkley Medical Resources, Inc. between 1996 and 1997. The busiest year on record is 1996, with 1. The most recent is 1997, with 1.

Clearances by year, as a table
510(k) clearance decisions for Berkley Medical Resources, Inc., by decision year
YearClearances
19961
19971
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K971744FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503)FXXSubstantially Equivalent
K9622862505 FACE MASK, TIE STRING / ANTI-FOG / FACE SHIELDFXXSubstantially Equivalent

Registered establishments

FDA registered establishments for Berkley Medical Resources, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
25184232518423BERKLEY MEDICAL RESOURCES, INC.700 Mountain View Dr, Smithfield, PA 15478 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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Data as of , FDA export datePage updated Source: openFDA, public domain