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Merz North America, Inc.

Last updated September 17, 2026

Information

Country: US
Address: 13900 W. Grandview Parkway, Sturtevant, WI, 53177
Website: www.radiesse.com
This website did not respond in time when we last checked. Last checked 2026-09-18.
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3013840437
DUNS Number: —

Catalogue (25)

Device	Model / Reference	Registries	Class	Status
Belotero Volume (+) Lidocaine	P250020	FDA PMA	Class III	Active
Radiesse Moderate Fill 0.8cc	8069M0K1	FDA UDI	Class III	Active
Prolaryn Plus Injectable Implant	8044M0K5	FDA UDI	Class II	Active
Radiesse (+) Lidocaine	8063M0K2	FDA UDI	Class III	Active
Radiesse Volume Advantage	8071M0K2	FDA UDI	Class III	Active
Radiesse Injectable Implant1.5cc	8071M0H1	FDA UDI	Class III	Active
Belotero Balance	8700M0	FDA UDI	Class III	Unknown
Radiesse (+) Lidocaine1.5cc Injectable Implant	8063M0K1	FDA UDI	Class III	Active
DeScribe Transparent PFD Patch	5035837	FDA UDI	Class II	Active
DeScribe Transparent PFD Patch	5035836	FDA UDI	Class II	Active
Rigid Needle 21 GA x 0.5" (0, 8 x 13 mm)	9012M0	FDA UDI	Class I	Active
Coaptite	8005M0	FDA UDI	Class III	Active
Radiesse Volume Advantage 1.5cc	8071C0K1	FDA UDI	Class III	Active
Radiesse Volume Advantage 1.5cc	8071M0K1	FDA UDI	Class III	Active
K-Pack II Needle 27 GA x 0.75" T.W. (0, 4 x 20mm)	9022M1X20	FDA UDI	Class I	Active
DeScribe Transparent PFD Patch	5035838	FDA UDI	Class II	Active
Coaptite	8005P10	FDA UDI	Class III	Active
Radiesse (+) Lidocaine 0.8cc Injectable Implant	8067M0K1	FDA UDI	Class III	Active
Prolaryn Gel Injectable Implant	8602M0K5	FDA UDI	Class II	Active
DESCRIBE PFD Patch	K172689	FDA 510(k)	Class II	Active
Symani Surgical System	DEN230032	FDA 510(k)	Class II	Active
RADIESSE Injectable Implant	P050037	FDA PMA	Class III	Active
Belotero Balance (+) Lidocaine Dermal Filler	P090016	FDA PMA	Class III	Active
Coaptite Injectable Implant	P040047	FDA PMA	Class III	Active
Radiesse Dermal Filler	P050052	FDA PMA	Class III	Active

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FDA Recalls (5)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 30, 2020	Z-0401-2021	—	open, classified	The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.
May 20, 2016	Z-2607-2016	—	terminated	Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.
Oct 26, 2015	Z-0366-2016	—	terminated	The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
Oct 26, 2015	Z-0367-2016	—	terminated	The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
Oct 26, 2015	Z-0368-2016	—	terminated	The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.