FDA.reportPublic FDA data

Dymax, Corp.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30130415943013041594Dymax, Corp.1Y2027-01-01141 Zehner School Rd Zelienople PA US 16063

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2006521950604295K182281Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle TechIYO2018-10-24
2006521783837013K161208CROSSER CTO Recanalization CatheterPDU2016-05-24
2006521537356588K152554Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT TechnologyIYO2015-12-14
2006522047683441K112308CROSSER RECANALIZATION SYSTEMPDU2011-08-17
2006521658740171K090621FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100DXT2009-06-19
2006521772637393K042445SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KITITX2004-10-19
2006521873982812K013641SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CORD,CONNECTOR CORDS AND FOOTSWITCH), VACUUMSGEI2002-01-29
2006521024766596
2006521001711949
2006521010397142
2006521013352141
2006521173450534
2006521177467113
2006521242515245
2006521244504113
2006521244616393
2006521355619215
2006521414219778
2006521477820725
2006521507304590
2006521535470402
2006521625836894
2006521656540773
2006521706872265
2006521735135683
2006521783507433
2006521793281838
2006521815325121
2006521831106899
2006521996148034
2006522005993443

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYO22018-10-24
PDU22016-05-24
DXT12009-06-19
ITX12004-10-19
GEI12002-01-29