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Data / Medical devices / Elastomer, Silicone, For Scar Management / United States

FDA-registered makers of Elastomer, Silicone, For Scar Management in the United States: 42 establishments

42 establishments in the United States are registered with the FDA to make Elastomer, Silicone, For Scar Management (product code MDA). 9 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Device
Elastomer, Silicone, For Scar Management
Product code
MDA
Country
United States

Makers of Elastomer, Silicone, For Scar Management in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Bio Med Sciences, Inc.Allentown, PA, United StatesSpecification developer4August 31, 2000000api.fda.gov
Nuance Medical, LLCLas Vegas, NV, United StatesManufacturer4January 29, 2001000api.fda.gov
Implantech Associates, Inc.Ventura, CA, United StatesContract manufacturer, Manufacturer3February 7, 2002000api.fda.gov
Advanced Bio-Technologies, Inc.Tampa, FL, United StatesComplaint file establishment, Specification developer2April 14, 2006000api.fda.gov
Crown Delta Corp.Yorktown, NY, United StatesManufacturer2September 14, 1990000api.fda.gov
Dsaart, LLCCarson City, NV, United StatesManufacturer1January 23, 2003000api.fda.gov
Gottfried Medical, Inc.Toledo, OH, United StatesManufacturer1May 30, 2001000api.fda.gov
Hanson Medical, Inc.Paso Robles, CA, United StatesManufacturer1August 12, 2004000api.fda.gov
Newmedical Technology, Inc.Northbrook, IL, United StatesManufacturer, Specification developer1October 17, 2005000api.fda.gov
3-Point Products, Inc.Stevensville, MD, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Advantice Health, LLCBridgewater, NJ, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Aim Medical IncWestwood, MA, United StatesSpecification developer0000api.fda.gov
Alliance Pharma Inc.Cary, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Alps South LLCSaint Petersburg, FL, United StatesManufacturer0000api.fda.gov
Atlantic Medical Products, LLCSaint Petersburg, FL, United StatesSpecification developer0000api.fda.gov
Bio-Concepts, Inc.Phoenix, AZ, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Blaine Labs, Inc.Santa Fe Springs, CA, United StatesManufacturer0000api.fda.gov
Boston Medical Products, Inc.Shrewsbury, MA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Cordica Medical, Inc.Haverhill, MA, United StatesContract manufacturer0000api.fda.gov
Excelsior Commercial Inc.Chicago, IL, United StatesManufacturer0000api.fda.gov
Formulated Solutions, LLCLargo, FL, United StatesContract manufacturer0000api.fda.gov
FridaBaby LLCMiami, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Lindo ManufacturingSwansea, MA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Marian MonticelloMonticello, IN, United StatesContract manufacturer0000api.fda.gov
Med Way Inc.Buford, GA, United StatesManufacturer0000api.fda.gov
North Coast Medical, Inc.Morgan Hill, CA, United StatesManufacturer0000api.fda.gov
NORTHWEST COSMETIC LABS, LLC d/b/a Elevation Labs IdahoIdaho Falls, ID, United StatesContract manufacturer0000api.fda.gov
Neodyne Biosciences, Inc.Fremont, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Polygel LLC.Palmer TWP, PA, United StatesSpecification developer0000api.fda.gov
Polymer Science, Inc.Monticello, IN, United StatesContract manufacturer0000api.fda.gov
Preco, LLCSomerset, WI, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Pure Source, LLCDoral, FL, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Precision Converting EastSarasota, FL, United StatesContract manufacturer0000api.fda.gov
Resilia Pharmaceuticals, Inc.Atlanta, GA, United StatesSpecification developer0000api.fda.gov
Safe N Simple LLCClarkston, MI, United StatesSpecification developer0000api.fda.gov
Scar Solutions LLCMiami, FL, United StatesManufacturer0000api.fda.gov
Silicone Medical Products & ServicesFlowery Branch, GA, United StatesManufacturer0000api.fda.gov
Star Port IncDenver, CO, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Talbot's Pharmaceuticals Family Products LLCMonroe, LA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
The Ergo Baby Carrier, Inc.Concord, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
TRADEMARK COSMETICS INC. DBA DMI SolutionsRiverside, CA, United StatesContract manufacturer0000api.fda.gov
Wacker Silicone Manufactured Innovations LLCAllentown, PA, United StatesContract manufacturer0000api.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.