MedtechSourcebook

Dymax, Corp.

Contract manufacturer · Zelienople, PA

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration
3013041594 (openFDA record; or search FDA's registration database)
FEI number
3013041594
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer; Remanufacturer; Repackager or relabeler
Owner or operator
C. R. Bard, Inc. (FDA owner/operator no. 2212754)
Registered address
141 Zehner School Rd, Zelienople, PA 16063
Contract listings
25 device listings, 12 product codes, first listed May 23, 2005
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
DWJSystem, Thermal RegulatingClass IICardiovascularContract manufacturingSep 7, 2016
EXSUrinometer, ElectricalClass IIGastroenterology and urologyContract manufacturingFeb 24, 2012
FOXStand, InfusionClass IGeneral hospitalContract manufacturingJan 23, 2014
GEXPowered Laser Surgical InstrumentClass IIGeneral and plastic surgeryContract manufacturingMar 26, 2026
ITXTransducer, Ultrasonic, DiagnosticClass IIRadiologyContract manufacturingMay 23, 2005
IYNSystem, Imaging, Pulsed Doppler, UltrasonicClass IIRadiologyContract manufacturingMar 12, 2010
IYOSystem, Imaging, Pulsed Echo, UltrasonicClass IIRadiologyContract manufacturingOct 23, 2007
KNWInstrument, BiopsyClass IIGastroenterology and urologyContract manufacturingJan 8, 2009
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysClass IIGeneral hospitalContract manufacturingOct 22, 2007
LLZSystem, Image Processing, RadiologicalClass IIRadiologyContract manufacturingMar 12, 2010
LRJDisinfectant, Medical DevicesClass IGeneral hospitalContract manufacturingOct 28, 2020
NZUCollector, Urine, Powered, Non Indwelling CatheterClass IGastroenterology and urologyContract manufacturingJan 10, 2018

Other contract facilities of C. R. Bard, Inc.