Founded by Giovanna McCarthy in 2017 after her work alongside plastic surgeons in Italy, Liverpool, New York-based PDO Max designs and supplies FDA-cleared polydioxanone threads and related aesthetic medical devices for soft-tissue approximation. The woman-owned company develops its own specifications, works with an ISO-certified manufacturer in South Korea, and pairs its products with hands-on practitioner training and continuing support. PDO Max also makes PDO AfterGlo®, described as the first topical PDO serum.
FDA clearance K190245
registration
FDA clearance K210871
registration
ISO 13485
certification
MDSAP (Medical Device Single Audit Program)
compliance_program
Woman-Owned Company
certification
V Soft LiftFounded in 2013, V Soft Lift develops and supplies PDO threads for regenerative aesthetic treatments, pairing its products with practitioner training and clinical support. Its threads are FDA-cleared as a Class II medical device for the thread-in-cannula unit and CE Medical Device certified, while the company says its polymer-coated designs deliver tensile strength 10–20 times greater than comparable threads. V Soft Lift also partners with the American Association of Facial Esthetics to offer certification courses for providers.SOUTH EUCLID, OH
ApolomedFounded in 2001, Shanghai-based Apolomed designs and manufactures professional medical aesthetic systems, with more than 135,000 square feet dedicated to manufacturing and research and development. Its platforms are used by distributors and clinics in more than 80 countries, while regional service centers in New York and Toronto extend factory-direct training and technical support. Apolomed operates under ISO 13485 and MDSAP quality certifications and holds market-specific clearances and registrations, including U.S. FDA 510(k) authorizations.BETHPAGE, NY
Pepper MedicalSince its founding in 1992, Pepper Medical has been a women-owned manufacturer focused on medical devices designed around patient comfort and safety. The company serves the healthcare market with disposable respiratory and urological products, while also developing custom devices for specific clinical needs. Its operations are certified to ISO 13485:2016 for medical-device design and manufacturing.WEST CHESTER, PA
FEMSelectFEMSelect develops women’s-health medical devices for pelvic floor conditions, notably EnPlace, a mesh-free system for minimally invasive, same-day pelvic organ prolapse repair. The company grew from POP Medical Solutions, which began developing the technology in 2013, received FDA clearance in 2016, and changed its name to FEMSelect in 2019. FEMSelect is woman-led and also offers FDA-cleared Elitone devices for at-home urinary-incontinence treatment.MANHATTAN, NY