Data / Medical devices / United States / Dymax, Corp.

Dymax, Corp.: FDA-registered device maker in Zelienople, PA, United States, 3 510(k) clearances

Name: Dymax, Corp. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Dymax, Corp. is registered with the FDA (registration 3013041594) in Zelienople, PA, United States. It lists 12 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 24, 2018. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3013041594
Address: 141 Zehner School Rd, Zelienople, PA, United States, 16063
Owner or operator: C. R. Bard, Inc. (2212754)
Roles: Contract manufacturer, Remanufacturer, Repackager or relabeler
First device listed: May 23, 2005
Registered through: 2027
Brand names listed: Arctic Sun Cleaning Solution, Arctic Sun Stat Temperature Management System, Arctic Sun Temperature Management System, Arctic Sun Temperature Management System (Model 5000), Bard CritiCore, Bard Dual Connector to 3.5 mm Plug 12' Monitor Cable, Collection Canister, Elyra Thulium Fiber Laser System and Accessories and more

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	LJS	2	Contract manufacturer	accessdata.fda.gov
Collector, Urine, Powered, Non Indwelling Catheter	NZU	1	Contract manufacturer	accessdata.fda.gov
Disinfectant, Medical Devices	LRJ	1	Contract manufacturer	accessdata.fda.gov
Instrument, Biopsy	KNW	2	Contract manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Contract manufacturer	accessdata.fda.gov
Stand, Infusion	FOX	1	Contract manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Contract manufacturer, Remanufacturer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Contract manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Contract manufacturer, Remanufacturer	accessdata.fda.gov
System, Thermal Regulating	DWJ	2	Contract manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Contract manufacturer, Remanufacturer, Repackager or relabeler	accessdata.fda.gov
Urinometer, Electrical	EXS	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 24, 2018	K182281	Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech	IYO	Substantially Equivalent	C. R. Bard	accessdata.fda.gov
December 14, 2015	K152554	Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology	IYO	Substantially Equivalent	C.R. Bard, Inc.	accessdata.fda.gov
October 19, 2004	K042445	SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT	ITX	Substantially Equivalent	Bard Access Systems, Inc.	accessdata.fda.gov

Compare with other makers

Updated October 24, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.