Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014226707

FEI Number

3014226707

Entity Name

BARDY DIAGNOSTICS, INC.

City/State/Country

Bellevue, WA, US

Establishment Address

220 120th Avenue NE, Suite 100, Bellevue, WA 98005, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

BAXTER HEALTHCARE CORPORATION (Owner Number: 1417572)

Owner / Operator Contact Address

One Baxter Parkway, Deerfield, IL 60015, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CAM System Adhesive Ring

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	Class 2	870.2800	2023-12-12
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2014-04-15

Official Correspondent

Maha Nolasco

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BAXTER HEALTHCARE CORPORATION

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3019257308	VIDEOMED SRL	LIMENA Padova, IT
1314492	Baxter Healthcare Corporation	MEDINA, NY, US
3007143268	Baxter Medical Systems GmbH + Co. KG	SAALFELD Thuringia, DE
8010130	BAXTER SA	LESSINES Hainaut, BE
3013836619	Baxter Medical Systems (Suzhou) Co. Ltd	Taicang City Jiangsu, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Similar Registrations

Registration Number	Establishment Name	Location
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
1527715	SCOTTCARE CORPORATION	CLEVELAND, OH, US
3000126629	Philips Electronics Ltd	Mississauga Ontario, CA
3030721635	ICENTIA LLC	Burlington, VT, US
3003971136	EDAN INSTRUMENTS, INC.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014226707. Last updated year: 2026. Please use registration number 3014226707 when referencing this establishment in official correspondence.