External Breast Prosthesis Suppliers
Limit companies to: Worldwide USA
SAI Therapeutic Brands | Address: 3960 Rosslyn Drive, Cincinnati, Ohio 45209-1195, USA 
surgicalappliance.com | Send Inquiry | Phone: +001-(800)-888-0458
Year Established: 1893 Annual Revenues: USD 25-50 Million Employee Count: ~350
Products: Ankle Braces, Elbow Braces, Knee Braces, Hand and Wrist Braces, Lumbosacral Braces, Skin Closures, Knee Braces, ...
SAI Therapeutic Brands deals with healthcare products. Our products are divided into four major brand categories such as Truform therapeutic compression hosiery, Truform OTC orthotics & prosthetics, A more...
surgicalappliance.com | Send Inquiry | Phone: +001-(800)-888-0458
Year Established: 1893 Annual Revenues: USD 25-50 Million Employee Count: ~350
Products: Ankle Braces, Elbow Braces, Knee Braces, Hand and Wrist Braces, Lumbosacral Braces, Skin Closures, Knee Braces, ...
SAI Therapeutic Brands deals with healthcare products. Our products are divided into four major brand categories such as Truform therapeutic compression hosiery, Truform OTC orthotics & prosthetics, A more...
Finebrand Co. | Address: 3720 S. Santa Fe Ave., Los Angeles, California 90058-1711, USA
www.finebrand.net | Send Inquiry | Phone: +1-(323)-588-3228
Annual Revenues: < USD 1 Million Employee Count: ~10
Products: Disposable Breast Pads, Holter Monitoring, Shoulder Straps and Belt, Breast Pads, Surgical Tapes, Small & Male Breast Paddles, External Breast Prosthesis (FDA Code: KCZ), ...
Finebrand Co. offers surgical products for women. Our products include surgical webbings, tapes, buckles, stays and mastectomy pads. more...
www.finebrand.net | Send Inquiry | Phone: +1-(323)-588-3228
Annual Revenues: < USD 1 Million Employee Count: ~10
Products: Disposable Breast Pads, Holter Monitoring, Shoulder Straps and Belt, Breast Pads, Surgical Tapes, Small & Male Breast Paddles, External Breast Prosthesis (FDA Code: KCZ), ...
Finebrand Co. offers surgical products for women. Our products include surgical webbings, tapes, buckles, stays and mastectomy pads. more...
Saville 1300, Inc. | Address: 200 Culver Blvd., Suite D, Playa del Rey, California 90293, USA
www.saville1300inc.com | Send Inquiry | Phone: +1-(909)-338-8360, 888-824-9929
Year Established: 1986 Annual Revenues: USD 1-5 Million
Products: External Breast Prosthesis (FDA Code: KCZ), ...
Saville 1300, Inc. distributes postmastectomy silicone breast forms, prosthetics, enhancers, and specialty enhancers. Our product line includes silicone Le'Breast prosthetics/enhancers/crossover forms more...
www.saville1300inc.com | Send Inquiry | Phone: +1-(909)-338-8360, 888-824-9929
Year Established: 1986 Annual Revenues: USD 1-5 Million
Products: External Breast Prosthesis (FDA Code: KCZ), ...
Saville 1300, Inc. distributes postmastectomy silicone breast forms, prosthetics, enhancers, and specialty enhancers. Our product line includes silicone Le'Breast prosthetics/enhancers/crossover forms more...
Jodee, Inc. | Address: P.O. Box 833837, Hollywood, Florida 33083-3837, USA
retail.jodee.com | Send Inquiry | Phone: +1-(954)-926-1900/800-865-6333,
FDA Registration: 1039386 Year Established: 1971 Annual Revenues: USD 10-25 Million
Products: Mastectomy Bras, Disposable Breast Pads, Breast Forms, Breast Prostheses, Mastectomy Clothing Kits, Breast Pads, ...
Jodee Bra supplies bathing suits, swim suits, silicone breast forms, foam breast forms and cushions. We also offer mastectomy bra, & perma form bra. more...
retail.jodee.com | Send Inquiry | Phone: +1-(954)-926-1900/800-865-6333,
FDA Registration: 1039386 Year Established: 1971 Annual Revenues: USD 10-25 Million
Products: Mastectomy Bras, Disposable Breast Pads, Breast Forms, Breast Prostheses, Mastectomy Clothing Kits, Breast Pads, ...
Jodee Bra supplies bathing suits, swim suits, silicone breast forms, foam breast forms and cushions. We also offer mastectomy bra, & perma form bra. more...
Amoena | Address: 1701 Barret Lakes Blvd., Suite 410, Kennesaw, Georgia 30144, USA
www.us.amoena.com | Send Inquiry | Phone: +1-(770)-281-8300, 800-726-6362
FDA Registration: 1000641183 Year Established: 1977 Annual Revenues: USD 10-25 Million Employee Count: ~60 Quality: CE Certified
Products: Incontinence Waterproof Swimwear, External Breast Prosthesis (FDA Code: KCZ), External Prosthesis Adhesive (FDA Code: GBJ), Headscarves, Symmetry Shapers, Adhesive Nipples, ...
Amoena produces post-breast surgery products for women. Our product line includes post-breast surgery bras, breast forms, symmetry shapers, breast form accessories and post-operative products. Our pos more...
www.us.amoena.com | Send Inquiry | Phone: +1-(770)-281-8300, 800-726-6362
FDA Registration: 1000641183 Year Established: 1977 Annual Revenues: USD 10-25 Million Employee Count: ~60 Quality: CE Certified
Products: Incontinence Waterproof Swimwear, External Breast Prosthesis (FDA Code: KCZ), External Prosthesis Adhesive (FDA Code: GBJ), Headscarves, Symmetry Shapers, Adhesive Nipples, ...
Amoena produces post-breast surgery products for women. Our product line includes post-breast surgery bras, breast forms, symmetry shapers, breast form accessories and post-operative products. Our pos more...
B & B Lingerie Company, Inc. | Address: 2417 Bank Dr., Suite 201, P.O. Box 5731, Boise, Idaho 83705, USA
www.bosombuddy.com | Send Inquiry | Phone: +1-(208)-343-9696, 800-262-2789
Year Established: 1976 Annual Revenues: < USD 1 Million Employee Count: ~20
Products: External Breast Prosthesis (FDA Code: KCZ), ...
B & B Lingerie Company, Inc. offers breast prostheses for mastectomees. Our Bosom Buddy® breast forms have an all-fabric construction, with no silicone, plastic or rubber used in the forms. The fo more...
www.bosombuddy.com | Send Inquiry | Phone: +1-(208)-343-9696, 800-262-2789
Year Established: 1976 Annual Revenues: < USD 1 Million Employee Count: ~20
Products: External Breast Prosthesis (FDA Code: KCZ), ...
B & B Lingerie Company, Inc. offers breast prostheses for mastectomees. Our Bosom Buddy® breast forms have an all-fabric construction, with no silicone, plastic or rubber used in the forms. The fo more...
Action Products, Inc. | Address: 22 N. Mulberry Street, Hagerstown, Maryland 21740, USA
www.actionproducts.com | Send Inquiry | Phone: (301)-797-14/800-228-7763
FDA Registration: 1181047 Year Established: 1970 Annual Revenues: USD 10-25 Million Employee Count: ~150 Quality: ISO 9000, CE Certified
Products: Orthopedic Cushions, Conductor Transmission Gel, Orthopedic Seat Cushions, Curvature Cushions, Back Cushions, Seat Cushions & Wedges, ...
Action Products, Inc. is the manufacturer of Aktonr Viscoelastic polymer, specifically designed to prevent decubitus ulcers. We provide operating room and DME/Rehab medical products, pads and position more...
www.actionproducts.com | Send Inquiry | Phone: (301)-797-14/800-228-7763
FDA Registration: 1181047 Year Established: 1970 Annual Revenues: USD 10-25 Million Employee Count: ~150 Quality: ISO 9000, CE Certified
Products: Orthopedic Cushions, Conductor Transmission Gel, Orthopedic Seat Cushions, Curvature Cushions, Back Cushions, Seat Cushions & Wedges, ...
Action Products, Inc. is the manufacturer of Aktonr Viscoelastic polymer, specifically designed to prevent decubitus ulcers. We provide operating room and DME/Rehab medical products, pads and position more...
Trulife, Inc. | Address: 2010 East High Street, Jackson, Michigan 49204, USA
trulife.biz | Send Inquiry | Phone: +1-(800)-788-2267
FDA Registration: 3022549
Products: Orthopedic Cushions, Foams, Conductor Transmission Gel, Curvature Cushions, Back Cushions, Seat Cushion Foam, ...
Trulife, Inc.is a manufacturer and marketer of niche healthcare products. We offer orthopedics, prosthetics, breastcare and pressurecare(models such as Oasis, Oasis Elite, Azure) products, walking aid more...
trulife.biz | Send Inquiry | Phone: +1-(800)-788-2267
FDA Registration: 3022549
Products: Orthopedic Cushions, Foams, Conductor Transmission Gel, Curvature Cushions, Back Cushions, Seat Cushion Foam, ...
Trulife, Inc.is a manufacturer and marketer of niche healthcare products. We offer orthopedics, prosthetics, breastcare and pressurecare(models such as Oasis, Oasis Elite, Azure) products, walking aid more...
Freeman | Address: 900 W. Chicago Road, Sturgis, Michigan 49091, USA
www.freemanmfg.com | Send Inquiry | Phone: +1-(269)-651-2371, 800-253-2091
FDA Registration: 1811757 Annual Revenues: USD 5-10 Million Employee Count: ~40
Products: Adult Foot & Ankle Splints, Adult Hand & Wrist Splints, Ankle Braces & Supports, Back Supports, Ankle Foot Orthosis, Ankle Support, ...
Freeman is a manufacturer of orthopedic softgoods to the global healthcare community. Our products range in diversity from a full line of back support garments and spinal braces to home healthcare pro more...
www.freemanmfg.com | Send Inquiry | Phone: +1-(269)-651-2371, 800-253-2091
FDA Registration: 1811757 Annual Revenues: USD 5-10 Million Employee Count: ~40
Products: Adult Foot & Ankle Splints, Adult Hand & Wrist Splints, Ankle Braces & Supports, Back Supports, Ankle Foot Orthosis, Ankle Support, ...
Freeman is a manufacturer of orthopedic softgoods to the global healthcare community. Our products range in diversity from a full line of back support garments and spinal braces to home healthcare pro more...
LA Charme LLC | Address: 45 Main St., Ste. 309 #22, Brooklyn, New York 11201, USA
Phone: +1-(718)-816-1347
Products: External Breast Prosthesis (FDA Code: KCZ), ...
LA Charme LLC specializes in providing breast prostheses and breast forms. more...
Phone: +1-(718)-816-1347
Products: External Breast Prosthesis (FDA Code: KCZ), ...
LA Charme LLC specializes in providing breast prostheses and breast forms. more...
Ladies First, Inc. | Address: P.O. Box 4400, Salem, Oregon 97302, USA
www.ladiesfirst.com | Send Inquiry | Phone: +1-(503)-363-3980, 800-497-8285
Year Established: 1990
Products: External Breast Prosthesis (FDA Code: KCZ), Surgical Brassiere, ...
Ladies First, Inc. offers after-breast-surgery and immediate post mastectomy products. Our products include breast forms, bras, panties and camisoles. Our products are all hypoallergenic and always la more...
www.ladiesfirst.com | Send Inquiry | Phone: +1-(503)-363-3980, 800-497-8285
Year Established: 1990
Products: External Breast Prosthesis (FDA Code: KCZ), Surgical Brassiere, ...
Ladies First, Inc. offers after-breast-surgery and immediate post mastectomy products. Our products include breast forms, bras, panties and camisoles. Our products are all hypoallergenic and always la more...
Health Related Products, Inc. | Address: P.O.Box No. 3465, Greenwood, South Carolina 29649, USA
www.hrp.greenwood.net | Send Inquiry | Phone: +1-(864)-229-1262, 800-845-4566
Products: Allergy Syringes/Trays, Adhesive Bandages (FDA Code: KGX), Adult Reusable Incontinence Pads, Adult Disposable Incontinence Pads, Antimicrobial Barrier Dressing, Anti-Embolism Stockings, ...
Health Related Products, Inc. is a distributor of adult incontinence, wound care, and accessory products. Realastic® production coverings are available in two styles including vinyl and silicone. more...
www.hrp.greenwood.net | Send Inquiry | Phone: +1-(864)-229-1262, 800-845-4566
Products: Allergy Syringes/Trays, Adhesive Bandages (FDA Code: KGX), Adult Reusable Incontinence Pads, Adult Disposable Incontinence Pads, Antimicrobial Barrier Dressing, Anti-Embolism Stockings, ...
Health Related Products, Inc. is a distributor of adult incontinence, wound care, and accessory products. Realastic® production coverings are available in two styles including vinyl and silicone. more...
Nearly Me Technologies, Inc. | Address: 3630 South Interstate 35, Suite A, Waco, Texas 76706, USA
www.nearlyme.org | Phone: +1-(254)-662-1752/800-887-3370,
Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: CE Certified
Products: Disposable Breast Pads, Diabetes Skin Care Kits, Skin Care Products, Skin Care Kits, Breast Forms, Breast Prostheses, ...
Nearly Me Technologies, Inc. offers mastectomy and fashion product. We also develop retouch® scar reduction sheets, bodyguard® silicone sheeting for home use and tender touch® silicone gel more...
www.nearlyme.org | Phone: +1-(254)-662-1752/800-887-3370,
Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: CE Certified
Products: Disposable Breast Pads, Diabetes Skin Care Kits, Skin Care Products, Skin Care Kits, Breast Forms, Breast Prostheses, ...
Nearly Me Technologies, Inc. offers mastectomy and fashion product. We also develop retouch® scar reduction sheets, bodyguard® silicone sheeting for home use and tender touch® silicone gel more...
Thuasne North America | Address: 9415 Coppertop Loop, Suite D, Seattle, Washington 98110, USA
www.thuasnena.com | Send Inquiry | Phone: +1-(206)-8429177
Products: Elbow & Shoulder Orthoses, Back Orthoses, Ankle Foot Orthosis, Abdominal Orthosis (FDA Code: KTD), External Ankle Brace (FDA Code: ITW), External Brace Knee Joint (FDA Code: ITQ), ...
Thuasne North America deals with healthcare and medical solutions. Our range of solutions will meet needs of a broad audience depending on their condition, morphology or activity. Some of our products more...
www.thuasnena.com | Send Inquiry | Phone: +1-(206)-8429177
Products: Elbow & Shoulder Orthoses, Back Orthoses, Ankle Foot Orthosis, Abdominal Orthosis (FDA Code: KTD), External Ankle Brace (FDA Code: ITW), External Brace Knee Joint (FDA Code: ITQ), ...
Thuasne North America deals with healthcare and medical solutions. Our range of solutions will meet needs of a broad audience depending on their condition, morphology or activity. Some of our products more...
Medical Art Resources, Inc. | Address: 3400 S. 103rd St., Suite 200, Greenfield, Wisconsin 53227, USA
www.facialprosthetics.com | Send Inquiry | Phone: +1-(414)-543-1002, 877-203-7829
Products: Hand Prostheses, External Breast Prosthesis (FDA Code: KCZ), Maxillofacial Prosthesis, Facial Prosthetic Rehabilitations, Protective Facemasks, ...
Medical Art Resources, Inc. specializes in facial and hand prosthetics. Each prosthesis we make is carefully sculpted to restore visual balance and symmetry to the face or body. We serve patients with more...
www.facialprosthetics.com | Send Inquiry | Phone: +1-(414)-543-1002, 877-203-7829
Products: Hand Prostheses, External Breast Prosthesis (FDA Code: KCZ), Maxillofacial Prosthesis, Facial Prosthetic Rehabilitations, Protective Facemasks, ...
Medical Art Resources, Inc. specializes in facial and hand prosthetics. Each prosthesis we make is carefully sculpted to restore visual balance and symmetry to the face or body. We serve patients with more...
Jing Yun Plastic Co., Ltd. | Address: No. 49, Lane 199, San Juin Street, Shu Lin City, Taipei 238, Taiwan 
Phone: +886-(2)-26883610
FDA Registration: 3006123310
Products: Wheelchair Cushions, Breast Form System, Positioning Wheelchair Cushion, External Breast Prosthesis (FDA Code: KCZ), Skin Pressure Protector (FDA Code: FMP), No Adhesive External Breast Prosthesis (FDA Code: NOJ), ...
Jing Yun Plastic Co., Ltd. specializes in breast forms and wheelchair cushions. more...
Phone: +886-(2)-26883610
FDA Registration: 3006123310
Products: Wheelchair Cushions, Breast Form System, Positioning Wheelchair Cushion, External Breast Prosthesis (FDA Code: KCZ), Skin Pressure Protector (FDA Code: FMP), No Adhesive External Breast Prosthesis (FDA Code: NOJ), ...
Jing Yun Plastic Co., Ltd. specializes in breast forms and wheelchair cushions. more...
Biora Ab | Address: Medeon Science Park, Malmo S-205-12, Sweden
Phone: +46-(40)-32 13 33
FDA Registration: 9612827
Products: External Breast Prosthesis (FDA Code: KCZ), ...
Biora Ab offers external breast prosthesis. more...
Phone: +46-(40)-32 13 33
FDA Registration: 9612827
Products: External Breast Prosthesis (FDA Code: KCZ), ...
Biora Ab offers external breast prosthesis. more...
Trulife Ltd. | Address: Unit 3 Cookstown Industrial, Estate, Tallaght, Dublin 24, Ireland
www.trulife.com | Send Inquiry | Phone: +353-(1)-4511755
FDA Registration: 9615374 Employee Count: ~20 Quality: ISO Certified
Products: Custom Walking Crutches, External Breast Prosthesis (FDA Code: KCZ), Support Gel Test (FDA Code: JZR), Skin Pressure Protector (FDA Code: FMP), Limb & Truncal Orthosis (FDA Code: MRI), Wheelchair Cushions (FDA Code: IMP), ...
Trulife Ltd. is engaged in the creation, development, manufacture and marketing of niche healthcare products. Our activities encompass orthopedics, prosthetics, breastcare and pressurecare products, a more...
www.trulife.com | Send Inquiry | Phone: +353-(1)-4511755
FDA Registration: 9615374 Employee Count: ~20 Quality: ISO Certified
Products: Custom Walking Crutches, External Breast Prosthesis (FDA Code: KCZ), Support Gel Test (FDA Code: JZR), Skin Pressure Protector (FDA Code: FMP), Limb & Truncal Orthosis (FDA Code: MRI), Wheelchair Cushions (FDA Code: IMP), ...
Trulife Ltd. is engaged in the creation, development, manufacture and marketing of niche healthcare products. Our activities encompass orthopedics, prosthetics, breastcare and pressurecare products, a more...
General Surgical Co., (india) Pvt. Ltd. | Address: G-6 Gee Cee Crescent, 114, Ponamallee High Road, Chennai, Tamil Nadu 60084, India 
www.gescoindia.com | Send Inquiry | Phone: +91-(44)-2825 96 02
FDA Registration: 9613926 Quality: ISO 9001:2000 Certified
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Y-Stent Forceps, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ENT Forceps (FDA Code: KAE), ...
General Surgical Co., (india) Pvt. Ltd. is a manufacturer of surgical instruments. We produce medical & surgical disposables, general, ENT, neuro & spinal, orthopedic, gynecology & obstetrics, plastic more...
www.gescoindia.com | Send Inquiry | Phone: +91-(44)-2825 96 02
FDA Registration: 9613926 Quality: ISO 9001:2000 Certified
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Y-Stent Forceps, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ENT Forceps (FDA Code: KAE), ...
General Surgical Co., (india) Pvt. Ltd. is a manufacturer of surgical instruments. We produce medical & surgical disposables, general, ENT, neuro & spinal, orthopedic, gynecology & obstetrics, plastic more...
Dr. Helbig Gmbh & Co. Orthopaedische Produkte Kg | Address: 23, Foerchenholzstr, Bad Toelz 83646, Germany 
Phone: +49-(804)-18607
Products: External Breast Prosthesis (FDA Code: KCZ), ...
Dr. Helbig Gmbh & Co. Orthopaedische Produkte Kg offers breast prostheses. more...
Phone: +49-(804)-18607
Products: External Breast Prosthesis (FDA Code: KCZ), ...
Dr. Helbig Gmbh & Co. Orthopaedische Produkte Kg offers breast prostheses. more...
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FDA Code / Regulation: KCZ / 878.3800
An external aesthetic restoration prosthesis is a device intended to be used to construct an external artificial body structure, such as an ear, breast, or nose. Usually the device is made of silicone rubber and it may be fastened to the body with an external prosthesis adhesive. The device is not intended to be implanted.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9. If the device is intended for use without an external prosthesis adhesive to fasten it to the body, the device is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.
