The Stork Ib2C, Inc., a Rinovum Women’s Health company, markets The Stork OTC, an at-home conception device cleared for over-the-counter use by the FDA. Its device uses cervical-cap insemination, combining a semen-collecting cap and silicone sheath with an applicator for placement near the cervix. Company team members include staff in manufacturing engineering, regulatory affairs, clinical development, and quality.
FDA over-the-counter clearance (K140186)
Registration
FDA510KCLEARANCE
Quality certification
SCI Medic, IncSCI Medic, Inc. develops and supplies FDA-cleared home diagnostic devices and over-the-counter consumer health products, with a particular focus on pregnancy, ovulation, drug and urinary-tract testing. The company also builds private-label and control-branded programs for retailers, distributors and healthcare organizations across the United States and Canada, taking projects from product development through packaging and fulfillment. Its FDA-established facility follows 21 CFR 820 regulations and holds ISO 13485:2016 certification, while the company is certified by WBENC as a women’s business enterprise.FREDERICK, MD
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
YarlapCo-founded by daughter MaryEllen Reider and her father Brent, Yarlap makes an FDA-cleared pelvic-floor exercise device designed to perform Kegel workouts for women. The USA-based company combines Brent’s bio-mimicry electrostimulation expertise with MaryEllen’s focus on accessible, stigma-free pelvic-floor wellness, and its device is manufactured in Ireland.OXFORD, OH
CooperSurgical, IncCooperSurgical develops and manufactures medical products for fertility, reproductive care, and women's health, alongside laboratory and clinical services. The company reports nearly 35 years of work in fertility and women's health, more than 600 products, and manufacturing locations in the United States, Costa Rica, and Europe. Its Trumbull, Connecticut headquarters includes a main manufacturing facility and primary distribution center.NORTH TONAWANDA, NY