Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010659131

FEI Number

3010659131

Entity Name

CADENCE DEVICE, INC.

City/State/Country

Cranberry Township, PA, US

Establishment Address

250 W KENSINGER DR STE 400, Cranberry Township, PA 16066, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Cadence Device, Inc. (Owner Number: 10045803)

Owner / Operator Contact Address

250 West Kensinger Dr. Suite 400, Cranberry Township, PA 16066, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IVX Station Stock Solution Transfer Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2023-06-13
HWQ	Passer	Orthopedic	Class 1	888.4540	2015-12-07
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2017-12-15
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2014-12-03
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2016-12-27
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2020-08-07
MXC	Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)	Cardiovascular	Class 2	870.2800	2017-12-12
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2020-08-06
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2018-10-15
HWJ	Awl	Orthopedic	Class 1	888.4540	2020-12-31

Official Correspondent

Robert Hegedus

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cadence Device, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device	2025-01-22
K222718	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter	2023-03-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2017	Baxter Corporation Englewood	2	0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
Z-0040-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0041-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0042-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0043-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 6mm Offset (Green) Catalog Number: 72201716 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

Similar Registrations

Registration Number	Establishment Name	Location
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
2523676	B. BRAUN US DEVICE MANUFACTURING LLC	ALLENTOWN, PA, US
3016418550	Takeda Pharmaceuticals U.S.A., Inc.	Cambridge, MA, US
3042177665	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	BEST Noord-Brabant, NL
3012798826	BD SWITZERLAND SARL	Eysins Vaud, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010659131. Last updated year: 2026. Please use registration number 3010659131 when referencing this establishment in official correspondence.