MedtechSourcebook

Kimball Solutions - Indianapolis

Contract manufacturer · Indianapolis, IN

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

FDA registration
3004598644 (openFDA record; or search FDA's registration database)
FEI number
3004598644
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer
Owner or operator
KIMBALL SOLUTIONS GROUP, LLC (FDA owner/operator no. 9071700)
Registered address
2950 N Catherwood Ave, Indianapolis, IN 46219
Contract listings
17 device listings, 18 product codes, first listed Jun 14, 2016
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
BYZTrap, Sterile SpecimenClass IIGeneral hospitalContract manufacturingJun 14, 2016
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceClass IIEar, nose and throatContract manufacturingJul 5, 2022
ETNStimulator, NerveClass IIEar, nose and throatContract manufacturingJul 6, 2020
GCJLaparoscope, General & Plastic SurgeryClass IIGastroenterology and urologyContract manufacturingJun 14, 2016
GEIElectrosurgical, Cutting & Coagulation & AccessoriesClass IIGeneral and plastic surgeryContract manufacturingFeb 1, 2017
HBBMotor, Drill, PneumaticClass IINeurologyContract manufacturingApr 18, 2018
HBCMotor, Drill, ElectricClass IINeurologyContract manufacturingJul 5, 2022
HRXArthroscopeClass IIOrthopedicContract manufacturingMar 27, 2018
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentClass IGeneral and plastic surgeryContract manufacturingJul 19, 2022
JCXApparatus, Suction, Ward Use, Portable, Ac-PoweredClass IIGeneral and plastic surgeryContract manufacturingMar 26, 2026
KNWInstrument, BiopsyClass IIGastroenterology and urologyContract manufacturingJun 14, 2016
LYUAccessory, Surgical ApparelClass IGeneral and plastic surgeryContract manufacturingJun 14, 2016
NDNCement, Bone, VertebroplastyClass IIOrthopedicContract manufacturingMar 27, 2018
NSCInjector, PenClass IIGeneral hospitalContract manufacturingSep 12, 2022
OARInjector, Vertebroplasty (Does Not Contain Cement)Class IOrthopedicContract manufacturingMar 27, 2018
OCJSpinal Channeling Instrument, VertebroplastyClass IOrthopedicContract manufacturingDec 15, 2020
PDQNeurosurgical Nerve LocatorClass IIEar, nose and throatContract manufacturingJul 6, 2020
SFQElectrosurgical, Cutting & Coagulation & Accessories, For Cardiac Electrophysiology Device Implantation And RevisionClass IIGeneral and plastic surgeryContract manufacturingDec 9, 2025

Other contract facilities of KIMBALL SOLUTIONS GROUP, LLC