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

Merz North America, Inc.: FDA-registered device maker in Sturtevant, WI, United States, 15 510(k) clearances and 6 PMA approvals

Merz North America, Inc. is registered with the FDA (registration 3013840437) in Sturtevant, WI, United States. It lists 15 device types. The FDA files 15 510(k) clearances and 6 PMA approvals under its listings, the newest dated July 9, 2026. Registered through 2027. FDA data exported November 3, 2026.

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Get makers like this oneWatch Merz North America, Inc.
FDA registration number
3013840437
Address
13900 W. Grandview Parkway, Sturtevant, WI, United States, 53177
Owner or operator
Merz North America, Inc. (9043404)
Roles
Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed
August 5, 2003
Registered through
2027
Brand names listed
Accessory Kit, Belotero Balance (+) Lidocaine Dermal Filler, Belotero Balance Dermal Filler, Belotero Intense (+) Lidocaine, Belotero Volume (+) Lidocaine, CSH Cannula; STERiGLIDE, Cellfina System Prep Pack - CP1, Coaptite Injectable Implant and more

Devices it lists

DeviceProduct codeClassRoleSource
Agent, Bulking, Injectable For Gastro-Urology UseLNM3Manufactureraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Repackager or relabeleraccessdata.fda.gov
Focused Ultrasound For Tissue Heat Or Mechanical Cellular DisruptionOHV2Complaint file establishmentaccessdata.fda.gov
Implant, Dermal, For Aesthetic UseLMH3Complaint file establishment, Manufactureraccessdata.fda.gov
Implant, Dermal, For Aesthetic Use In The HandsPKY3Manufactureraccessdata.fda.gov
Instrument, Ent Manual SurgicalLRC1Repackager or relabeleraccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Complaint file establishmentaccessdata.fda.gov
Needle, Aspiration And Injection, DisposableGAA1Repackager or relabeleraccessdata.fda.gov
Needle, Gastro-UrologyFHR1Repackager or relabeleraccessdata.fda.gov
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)KHJ2Manufactureraccessdata.fda.gov
Powered Surgical Instrument For Improvement In The Appearance Of CelluliteOUP2Complaint file establishmentaccessdata.fda.gov
Single Use Instrument TrayOJV1Repackager or relabeleraccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Complaint file establishmentaccessdata.fda.gov
System, Vocal Cord MedializationMIX2Manufactureraccessdata.fda.gov
Transparent Patch For Use In Treatment Of TattoosPKO2Complaint file establishment, Specification developeraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 21, 2026K260618Ulthera® SystemOHVSubstantially EquivalentUlthera, Inc.accessdata.fda.gov
May 13, 2025K250418Ulthera System (UC-1 Control Unit PRIME Model 2.1)OHVSubstantially EquivalentUlthera, Inc.accessdata.fda.gov
February 24, 2025K243035Ulthera® SystemOHVSubstantially EquivalentUlthera, Inc.accessdata.fda.gov
February 22, 2024K233996Ulthera System (UC-1 Control Unit PRIME)OHVSubstantially EquivalentUlthera, Inc.accessdata.fda.gov
May 4, 2018K180623Ulthera SystemOHVSubstantially EquivalentUlthera, Inc.accessdata.fda.gov
November 29, 2017K172689DESCRIBE PFD PatchPKOSubstantially EquivalentMerz North America, Inc.accessdata.fda.gov
October 5, 2016K161885The Cellfina SystemOUPSubstantially EquivalentUlthera, Inc.accessdata.fda.gov
July 29, 2015K150505Cellfina SystemOUPSubstantially EquivalentUlthera, Inc.accessdata.fda.gov
June 20, 2014K134032ULTHERA SYSTEMOHVSubstantially EquivalentUlthera, Inc.accessdata.fda.gov
December 11, 2013K132028ULTHERA SYSTEMOHVSubstantially EquivalentUlthera, Inc.accessdata.fda.gov
October 2, 2012K121700ULTHERA SYSTEMOHVSubstantially EquivalentUlthera, Inc.accessdata.fda.gov
August 28, 2012K122528ULTHERA SYSTEMOHVSubstantially EquivalentUlthera, Inc.accessdata.fda.gov
September 11, 2009DEN080006ULTHERA SYSTEM, MODEL 8850-0001OHVUnknownUlthera, Inc.accessdata.fda.gov
April 18, 2006K060815JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANTMIXSubstantially EquivalentBioform Medical, Inc.accessdata.fda.gov
January 9, 2002K013243COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1KHJSubstantially EquivalentBioform, Inc.accessdata.fda.gov

PMA approvals

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

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
July 9, 2026P250016Belotero® Intense (+) LidocaineLMH4October 21, 2026accessdata.fda.gov
May 19, 2026P250020Belotero Volume (+) LidocaineLMH4September 10, 2026accessdata.fda.gov
November 14, 2011P090016BELOTERO BALANCELMH60May 3, 2026accessdata.fda.gov
December 22, 2006P050052RADIESSE INJECTABLE IMPLANTLMH169June 26, 2026accessdata.fda.gov
December 22, 2006P050037RADIESSE 1.3CC AND 0.3CCLMH147June 26, 2026accessdata.fda.gov
November 10, 2005P040047COAPTITELNM76June 26, 2026accessdata.fda.gov

Compare with other makers

Updated October 21, 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.