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

Houston, TX, US

TORAY INTERNATIONAL AMERICA INC. appears in FDA device records in Houston, TX. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
0
PMA records
0
Recall records
4
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Toray International America Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Toray Marketing & Sales (America), Increcall

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 Toray International America Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
16498693001632632TORAY INTERNATIONAL AMERICA INC.140 CYPRESS STATION DR., HOUSTON, TX 77090 US2026

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-0352-04Hollow Fiber Dialyzer, Model TORAYSULFONE BS-1.6, and BS-1.8Potential loose header (end cap) on hollow fiber dialyzers.Terminated
Z-0351-04Hollow Fiber Dialyzer, Model FILTRYZER BK-2.IUPotential loose header (end cap) on hollow fiber dialyzers.Terminated
Z-0350-04Hollow Fiber Dialyzer Model FILTRYZER B3-1.0A, B3 -1.3A, and B3-1.6aPotential loose header (end cap) on hollow fiber dialyzers.Terminated
Z-0349-04Hollow Fiber Dialyzer Model FILTRYZER B1-1.3HPotential loose header (end cap) on hollow fiber dialyzers.Terminated

Verification record

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