510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Pharmaplast S.A.E.

ALEXANDRIA Al, EG

PHARMAPLAST S.A.E. appears in FDA device records in ALEXANDRIA Al, EG. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show one recall 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
1
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Pharmaplast S.A.E. in 2013.

Clearances by year, as a table
510(k) clearance decisions for Pharmaplast S.A.E., by decision year
YearClearances
20131
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K130553ABSOCLEARFROSubstantially Equivalent

Registered establishments

FDA registered establishments for Pharmaplast S.A.E., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30037678913003767891PHARMAPLAST S.A.E.AMRIA free zone, ALEXANDRIA Al Iskandariyah 23512 EG2026and 14 more, listed in full below

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

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1875-2011CVS Pharmacy Plastic Sesame Street Adhesive Bandages; a sterile, latex free, assorted sizes with multiple designs adhesive bandages; 20 bandages per box, 24 boxes per case; Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in Egypt; REF CVS 826159, UPC 0 50428 95118 7 The device is used to cover and protect wounds.The bandages are labeled as sterile, but failed sterility testing.Terminated

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