Dymax, Corp.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3013041594	3013041594	Dymax, Corp.	1	Y	2026-01-01	141 Zehner School Rd Zelienople PA US 16063

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
200652	1950604295	K182281	Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech	IYO	2018-10-24
200652	1783837013	K161208	CROSSER CTO Recanalization Catheter	PDU	2016-05-24
200652	1537356588	K152554	Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology	IYO	2015-12-14
200652	2047683441	K112308	CROSSER RECANALIZATION SYSTEM	PDU	2011-08-17
200652	1658740171	K090621	FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100	DXT	2009-06-19
200652	1772637393	K042445	SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT	ITX	2004-10-19
200652	1873982812	K013641	SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CORD,CONNECTOR CORDS AND FOOTSWITCH), VACUUMS	GEI	2002-01-29
200652	1024766596
200652	1001711949
200652	1010397142
200652	1013352141
200652	1173450534
200652	1177467113
200652	1242515245
200652	1244504113
200652	1244616393
200652	1355619215
200652	1414219778
200652	1477820725
200652	1507304590
200652	1535470402
200652	1625836894
200652	1656540773
200652	1706872265
200652	1735135683
200652	1783507433
200652	1793281838
200652	1815325121
200652	1831106899
200652	1996148034
200652	2005993443