MedtechSourcebook

CADENCE DEVICE, INC.

Contract manufacturer · Cranberry Township, PA

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

FDA registration
3010659131 (openFDA record; or search FDA's registration database)
FEI number
3010659131
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer
Owner or operator
Cadence Device, Inc. (FDA owner/operator no. 10045803)
Registered address
250 W KENSINGER DR STE 400, Cranberry Township, PA 16066
Contract listings
11 device listings, 12 product codes, first listed Dec 3, 2014
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
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceClass IIEar, nose and throatContract manufacturingJul 23, 2021
GDXScalpel, One-PieceClass IGeneral and plastic surgeryContract manufacturingOct 15, 2018
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Class IINeurologyContract manufacturingJul 23, 2021
HSTApparatus, Traction, Non-PoweredClass IOrthopedicContract manufacturingDec 15, 2017
HTWBit, DrillClass IOrthopedicContract manufacturingMay 13, 2025
HWJAwlClass IOrthopedicContract manufacturingDec 31, 2020
HWQPasserClass IOrthopedicContract manufacturingDec 7, 2015
KDDKit, Surgical Instrument, DisposableClass IGeneral and plastic surgeryContract manufacturingDec 27, 2016
LHISet, I.V. Fluid TransferClass IIGeneral hospitalContract manufacturingJun 13, 2023
MXCRecorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)Class IICardiovascularContract manufacturingDec 12, 2017
NBHAccessories, ArthroscopicClass IOrthopedicContract manufacturingDec 3, 2014
NEPSystem/Device, Pharmacy CompoundingClass IIGeneral hospitalContract manufacturingJun 13, 2023