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Data / Medical devices / Implant, Dermal, For Aesthetic Use

Implant, Dermal, For Aesthetic Use (LMH): 19 FDA-registered makers in 8 countries

19 establishments in 8 countries are registered with the FDA to make Implant, Dermal, For Aesthetic Use (product code LMH, Class 3). 15 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 7 recall events (1 Class I). FDA data exported November 2, 2026.

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Product code
LMH
Device class
3
Medical specialty
Unknown
Implant
Yes

Makers by country

CountryMakers
United States6
Switzerland3
France3
Germany2
Canada2
Sweden1
Austria1
Italy1

Makers of Implant, Dermal, For Aesthetic Use

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Merz North America, Inc.Sturtevant, WI, United StatesComplaint file establishment, Manufacturer0500api.fda.gov
Anteis SAPlan les ouates Geneve, SwitzerlandManufacturer0300api.fda.gov
Q-Med ABUppsala, SwedenManufacturer0300api.fda.gov
AllerganAnnecy Haute-Savoie, FranceManufacturer0200api.fda.gov
Allergan Sales, LLCIrvine, CA, United StatesComplaint file establishment, Specification developer0200api.fda.gov
Anteis S.A.Lonay Vaud, SwitzerlandManufacturer0200api.fda.gov
Croma-Pharma GMBHLeobendorf Niederosterreich, AustriaComplaint file establishment, Manufacturer0200api.fda.gov
Merz North America, Inc.Franksville, WI, United StatesManufacturer0220api.fda.gov
MERZ AESTHETICS DessauDessau Saxony-Anhalt, GermanyManufacturer0100api.fda.gov
Prollenium Medical Technologies Inc.Aurora Ontario, CanadaComplaint file establishment, Manufacturer0110api.fda.gov
Prollenium Medical Technologies Inc.Richmond Hill Ontario, CanadaManufacturer0100api.fda.gov
SymateseChaponost Auvergne-Rhone-Alpes, FranceManufacturer0100api.fda.gov
SymateseVourles Auvergne-Rhone-Alpes, FranceManufacturer0100api.fda.gov
Teoxane S.A.Geneva Geneve, SwitzerlandComplaint file establishment, Manufacturer0100api.fda.gov
Tiger Aesthetics Medical-SDSan Diego, CA, United StatesManufacturer0100api.fda.gov
Merz Pharma GMBH & Co. KgaaReinheim Hesse, GermanyContract manufacturer0000api.fda.gov
Modane Laboratories, Inc.Monona, WI, United StatesManufacturer for export0000api.fda.gov
Sanofi S.r.l.ANAGNI Frosinone, ItalyContract manufacturer, Contract sterilizer0000api.fda.gov
Synergy Health AST, LLCSaxonburg, PA, United StatesManufacturer for export0000api.fda.gov

Updated November 2, 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.