Data / Medical devices / United States / Merz North America, Inc.

Merz North America, Inc.: FDA-registered device maker in Franksville, WI, United States, 3 510(k) clearances and 3 PMA approvals

Name: Merz North America, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Merz North America, Inc. is registered with the FDA (registration 2135225) in Franksville, WI, United States. It lists 11 device types. The FDA files 3 510(k) clearances and 3 PMA approvals under its listings, the newest dated November 29, 2017. 4 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 2135225
FEI number: 3003407669
Address: 4133 Courtney St., Suite 10, Franksville, WI, United States, 53126
Owner or operator: Merz North America, Inc. (9043404)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: August 5, 2003
Registered through: 2027
Brand names listed: Accessory Kit, CSH Cannula; STERiGLIDE, Coaptite Injectable Implant, Describe, Prolaryn Gel Injectable Implant, Prolaryn Plus Injectable Implant, Radiesse Injectable Implant, Radiesse® (+) and more

Devices it lists

Device	Product code	Class	Role	Source
Agent, Bulking, Injectable For Gastro-Urology Use	LNM	3	Manufacturer	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Repackager or relabeler	accessdata.fda.gov
Implant, Dermal, For Aesthetic Use	LMH	3	Manufacturer	accessdata.fda.gov
Implant, Dermal, For Aesthetic Use In The Hands	PKY	3	Manufacturer	accessdata.fda.gov
Instrument, Ent Manual Surgical	LRC	1	Repackager or relabeler	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Repackager or relabeler	accessdata.fda.gov
Needle, Gastro-Urology	FHR	1	Repackager or relabeler	accessdata.fda.gov
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)	KHJ	2	Manufacturer	accessdata.fda.gov
Single Use Instrument Tray	OJV	1	Repackager or relabeler	accessdata.fda.gov
System, Vocal Cord Medialization	MIX	2	Manufacturer	accessdata.fda.gov
Transparent Patch For Use In Treatment Of Tattoos	PKO	2	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 29, 2017	K172689	DESCRIBE PFD Patch	PKO	Substantially Equivalent	Merz North America, Inc.	accessdata.fda.gov
April 18, 2006	K060815	JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT	MIX	Substantially Equivalent	Bioform Medical, Inc.	accessdata.fda.gov
January 9, 2002	K013243	COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1	KHJ	Substantially Equivalent	Bioform, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
December 22, 2006	P050052	RADIESSE INJECTABLE IMPLANT	LMH	169	June 26, 2026	accessdata.fda.gov
December 22, 2006	P050037	RADIESSE 1.3CC AND 0.3CC	LMH	147	June 26, 2026	accessdata.fda.gov
November 10, 2005	P040047	COAPTITE	LNM	76	June 26, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
September 30, 2020	86572	Class II	Ongoing	COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calcium hydroxylapatite (CaHA), suspended in aqueous based gel carrier. Gel carrier i	The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.	accessdata.fda.gov
December 16, 2011	60851	Not yet classified	Terminated	MERZ AESTHETICS, 27G X 1.0 " (25MM) Cannula, Sterile R, QTY 20, Model 9015M1X20, Distributed by Merz Aesthetics, In., Manufactured by TSK Laboratory. The intended use of the Cannula is the injection of fluids into, or wi	Merz Aesthetics is initiating a medical device recall on TSK Closed Tip Cannula (27GA x 25mm) due to a labeling error on the secondary (outer) packaging. The outer package label states that the carton contains Cannulas that are 27GA x 25 mm in size instead of 27G x 38 mm. Length of the cannula is a matter of user preference and is unlikely to impact patient	accessdata.fda.gov
August 18, 2011	60046	Not yet classified	Terminated	MERZ AESTHETICS, Radiesse Volume Advantage 1.5 CC, Injectable Implant, Part Number 8071M0H1 and 8071M0K1, Sterile, Rx ONLY. Part Number 8071M4K1 distributed in Canada Part Number 8071M5 distributed in Europe/Middle East/	There is a potential leakage of product that may occur with Merz Aesthetics 1.5cc syringes of Radiesse Dermal Filler. When using the syringe, Health Care Professionals should be alerted to the potential for product that my leak pass the plunger at the proximal end of the syring. The defect may result in infection requiring medical intervention to prevent imp	accessdata.fda.gov
April 6, 2011	58614	Not yet classified	Terminated	Radiesse, Injectable Implant - 1.3cc Syringe, Sterile, Sterilized Using Steam, Use Before 2013-01, Ref 8046M7, Lot 1024417, Manufactured by: BioForm Medical Inc, 4133 Courtney Rd #10 Franksville, WI 53126. Subdermal impl	Merz Aesthetics, Inc. is recalling 1 lot (1034417) of Radiesse 1.3 cc Implant. The lot was supposed to be scrapped because it had failed to meet its Loss On Drying (LOD) specification. Unfortunately it had been marked as approved, released and shipped.	accessdata.fda.gov

Compare with other makers

Updated June 26, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.