Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2135225

FEI Number

3003407669

Entity Name

Merz North America, Inc.

City/State/Country

FRANKSVILLE, WI, US

Establishment Address

4133 Courtney St., Suite 10, FRANKSVILLE, WI 53126, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Merz North America, Inc. (Owner Number: 9043404)

Owner / Operator Contact Address

6501 Six Forks Road, Raleigh, NC 27615, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Rigid Injection Needle CSH Cannula; STERiGLIDE Prolaryn Plus Injectable Implant Coaptite Injectable Implant Radiesse Injectable Implant Radiesse® (+) Accessory Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2014-09-09
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2003-08-05
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2019-10-24
KHJ	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)	Ear, Nose, Throat	Class 2	874.3620	2007-12-04
LNM	Agent, Bulking, Injectable For Gastro-Urology Use	Unknown	Class 3	N/A	2007-12-04
LMH	Implant, Dermal, For Aesthetic Use	Unknown	Class 3	N/A	2007-12-04
PKY	Implant, Dermal, For Aesthetic Use In The Hands	Unknown	Class 3	N/A	2007-12-04
OJV	Single Use Instrument Tray	General, Plastic Surgery	Class 1	878.4800	2010-11-02
FHR	Needle, Gastro-Urology	General, Plastic Surgery	Class 1	878.4800	2019-06-10

Official Correspondent

Bonnie Safyurtlu

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Merz North America, 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
3013840437	Merz North America, Inc.	Sturtevant, WI, US
1012187	Ulthera Inc	Raleigh, NC, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09
K080022	Vascular Solutions, Inc.	GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP	2008-12-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011	Becton Dickinson & Company	1	BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.
Z-0040-06	Boston Scientific Corporation	3	Enteryx Procedure Kit Order No.: M00572600 -US and M00572500 -OUS

Similar Registrations

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3005440795	XINHUA SURGICAL INSTRUMENT CO. LTD.	ZIBO Shandong, CN
2529846	MED SAVER, INC.	PHOENIXVILLE, PA, US
3003790304	GYRUS ACMI, INC.	Westborough, MA, US
9615857	INSTRUMENTARIUM SURGICAL CORP., INC.	TERREBONNE Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2135225. Last updated year: 2026. Please use registration number 2135225 when referencing this establishment in official correspondence.