Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027529701

FEI Number

3027529701

Entity Name

LINKS MEDICAL PRODUCTS, INC.

City/State/Country

Scottsdale, AZ, US

Establishment Address

15979 N 76th Street, Suite D, --, Scottsdale, AZ 85260, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

LINKS MEDICAL PRODUCTS, INC. (Owner Number: 9040995)

Owner / Operator Contact Address

15979 N 76th Street, Suite D, --, Scottsdale, AZ 85260, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K120976

PMA Number

N/A

All Registered Proprietary Names

Silent Knight MANUKA FILL TheraHoney Gel Manuka Foam HC TheraHoney Foam TheraHoney Foam Flex Manuka Foam Air Silent Knight Pill Crushing Pouch Silent Knight Pill Crushing Pouch (NONPC-1001) LMP Diagnostics TheraHoney Gauze MANUKA IG TheraHoney Sheet HD TheraHoney Sheet Manuka IG Max Manuka IG Max Rope TheraHoney Sheet HD Ribbon

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OHY	Pill Crusher/Cutter	General Hospital	Class 1	880.6430	2014-10-13
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2014-05-14
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2014-05-14
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2000-04-06
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2025-08-29
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2013-01-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LINKS MEDICAL PRODUCTS, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2031987	LINKS MEDICAL PRODUCTS, INC.	Irvine, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0044-2008	Becton Dickinson & Company	2	Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417

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3005381264	E-Kai Industrial Co., Ltd.	Dongguan City Guangdong, CN
3008803692	MINIGRIP COMMERCIAL LLC	Hauppauge, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027529701. Last updated year: 2026. Please use registration number 3027529701 when referencing this establishment in official correspondence.