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

Spartanburg, SC, US

ISOMEDIX OPERATIONS INC. appears in FDA device records in Spartanburg, SC. FDA records list 2 510(k) clearances between and , no PMA records and 17 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
2
PMA records
0
Recall records
0
Registered establishments
17

510(k) clearance history

FDA records hold 2 510(k) clearances for Isomedix Operations Inc between 1995 and 1997. The busiest year on record is 1995, with 1. The most recent is 1997, with 1.

Clearances by year, as a table
510(k) clearance decisions for Isomedix Operations Inc, by decision year
YearClearances
19951
19971
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K970352SMARTVAC SMOKE EVACUATION SYSTEMFYDSubstantially Equivalent
K950047SCHNEIDER GEX(TM) .014/.018 GUIDEWIRE EXCHANGE CATHETERDQYSubstantially Equivalent

Registered establishments

FDA registered establishments for Isomedix Operations Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
15267111526711ISOMEDIX OPERATIONS INC4405 MARKETING PLACE, GROVEPORT, OH 43125 US2026and 72 more, listed in full below
16438171643817ISOMEDIX OPERATIONS INC1435 ISOMEDIX PLACE, EL PASO, TX 79936 US2026and 366 more, listed in full below
10478431047843ISOMEDIX OPERATIONS INC.2072 Southport Rd, SPARTANBURG, SC 29306 US2026and 214 more, listed in full below
12204771220477ISOMEDIX OPERATIONS INC.435 WHITNEY ST., Northborough, MA 01532 US2026and 286 more, listed in full below
13196601000136478ISOMEDIX OPERATIONS INC.23 ELIZABETH DR., CHESTER, NY 10918 US2026and 106 more, listed in full below
17209291720929ISOMEDIX OPERATIONS INC.9120 SOUTH 150 EAST, Sandy, UT 84070 US2026and 128 more, listed in full below
22453042245304ISOMEDIX OPERATIONS INC.9 Apollo Dr, WHIPPANY, NJ 07981 US2026and 134 more, listed in full below
30098883443009888344Isomedix Operations Inc1441 Don Haskins Dr, El Paso, TX 79936 US2026and 279 more, listed in full below
16509073002681132Isomedix Operations Inc.1175 Isuzu Pkwy, GRAND PRAIRIE, TX 75050 US2026and 62 more, listed in full below
20321123003076831Isomedix Operations Inc.7685 ST.ANDREWS AVE., SAN DIEGO, CA 92154 US2026and 127 more, listed in full below
22465522246552Isomedix Operations Inc.3459 SOUTH CLINTON AVE., S Plainfield, NJ 07080 US2026and 182 more, listed in full below
30138205013013820501Isomedix Operations Inc.2 Nucifora Blvd, Chester, NY 10918 US2026and 19 more, listed in full below
20320983003058448Isomedix Operations, Inc1000 Sarah Pl, ONTARIO, CA 91761 US2026and 165 more, listed in full below
14242633003015552Isomedix Operations, Inc.2500 Commerce Dr, Libertyville, IL 60048 US2026and 193 more, listed in full below
14506621450662Isomedix Operations, Inc.1880 Industrial Dr, Libertyville, IL 60048 US2026and 246 more, listed in full below
20306243000206435Isomedix Operations, Inc.43425 Business Park Dr, Temecula, CA 92590 US2026and 186 more, listed in full below
21837442183744Isomedix Operations, Inc.380 90TH AVE NW, Minneapolis, MN 55433 US2026and 269 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

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