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

Fenton, MO, US

KATENA PRODUCTS, INC. appears in FDA device records in Fenton, MO. FDA records list 3 510(k) clearances between and , no PMA records and 3 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
3
PMA records
0
Recall records
0
Registered establishments
3

510(k) clearance history

FDA records hold 3 510(k) clearances for Katena Products, Inc. between 1978 and 1992. The busiest year on record is 1978, with 1. The most recent is 1992, with 1.

Clearances by year, as a table
510(k) clearance decisions for Katena Products, Inc., by decision year
YearClearances
19781
19901
19921
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K912576INSTRUMENT WIPE AND CORNEAL SHIELDHOYSubstantially Equivalent
K897034K-SPONGEHOZSubstantially Equivalent
K781866CANNULA CADDYSubstantially Equivalent

Registered establishments

FDA registered establishments for Katena Products, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
19344203001180016KATENA PRODUCTS, INC.1317 HORAN DRIVE, Fenton, MO 63026 US2026and 11 more, listed in full below
22424502242450KATENA PRODUCTS, INC.4 Middlebury Boulevard, Randolph, NJ 07869 US2026and 60 more, listed in full below
30151776483015177648KATENA PRODUCTS, INC.6 CAMPUS DRIVE, Parsippany, NJ 07054 US2026and 55 more, listed in full below

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