MedtechSourcebook

FIRST ARTICLE INC

Contract manufacturer ยท Souderton, PA

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

2026Product codes first listed, by year (tallest: 30)2026
FDA registration
3010032903 (openFDA record; or search FDA's registration database)
FEI number
3010032903
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer
Owner or operator
First Article MFG LLC (FDA owner/operator no. 10095684)
Registered address
150 S Front St Suite B, Souderton, PA 18964
Contract listings
86 device listings, 30 product codes, first listed Apr 14, 2026
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
DSIDetector And Alarm, ArrhythmiaClass IICardiovascularContract manufacturingApr 14, 2026
FIPSubsystem, Water PurificationClass IIGastroenterology and urologyContract manufacturingApr 14, 2026
HAWNeurological Stereotaxic InstrumentClass IINeurologyContract manufacturingApr 14, 2026
HRSPlate, Fixation, BoneClass IIOrthopedicContract manufacturingApr 14, 2026
HRXArthroscopeClass IIOrthopedicContract manufacturingApr 14, 2026
HWCScrew, Fixation, BoneClass IIOrthopedicContract manufacturingApr 14, 2026
KWIProsthesis, Elbow, Hemi-, Radial, PolymerClass IIOrthopedicContract manufacturingApr 14, 2026
KWPAppliance, Fixation, Spinal InterlaminalClass IIOrthopedicContract manufacturingApr 14, 2026
KWQAppliance, Fixation, Spinal Intervertebral BodyClass IIOrthopedicContract manufacturingApr 14, 2026
MAXIntervertebral Fusion Device With Bone Graft, LumbarClass IIOrthopedicContract manufacturingApr 14, 2026
MNHOrthosis, Spondylolisthesis Spinal FixationClass IIOrthopedicContract manufacturingApr 14, 2026
MNIOrthosis, Spinal Pedicle FixationClass IIOrthopedicContract manufacturingApr 14, 2026
MQPSpinal Vertebral Body Replacement DeviceClass IIOrthopedicContract manufacturingApr 14, 2026
MRWSystem, Facet Screw Spinal DeviceUnclassifiedOrthopedicContract manufacturingApr 14, 2026
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Class IICardiovascularContract manufacturingApr 14, 2026
NKBThoracolumbosacral Pedicle Screw SystemClass IIOrthopedicContract manufacturingApr 14, 2026
NKGPosterior Cervical Screw SystemClass IIOrthopedicContract manufacturingApr 14, 2026
NQPPosterior Metal/Polymer Spinal System, FusionClass IIOrthopedicContract manufacturingApr 14, 2026
NQWOrthosis, Spine, Plate, Laminoplasty, MetalClass IIOrthopedicContract manufacturingApr 14, 2026
ODPIntervertebral Fusion Device With Bone Graft, CervicalClass IIOrthopedicContract manufacturingApr 14, 2026
OLOOrthopedic Stereotaxic InstrumentClass IINeurologyContract manufacturingApr 14, 2026
OSHPedicle Screw Spinal System, Adolescent Idiopathic ScoliosisClass IIOrthopedicContract manufacturingApr 14, 2026
OURSacroiliac Joint FixationClass IIOrthopedicContract manufacturingApr 14, 2026
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarClass IIOrthopedicContract manufacturingApr 14, 2026
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalClass IIOrthopedicContract manufacturingApr 14, 2026
OWIBone Fixation Cerclage, SublaminarClass IIOrthopedicContract manufacturingApr 14, 2026
PEKSpinous Process PlateClass IIOrthopedicContract manufacturingApr 14, 2026
PHMIntervertebral Fusion Device With Bone Graft, ThoracicClass IIOrthopedicContract manufacturingApr 14, 2026
PLRSpinal Vertebral Body Replacement Device - CervicalClass IIOrthopedicContract manufacturingApr 14, 2026
PMLBone Cement, Posterior Screw AugmentationClass IIOrthopedicContract manufacturingApr 14, 2026