Best FDA Device Suppliers
Discover a curated selection of globally recognized FDA-approved device manufacturers specializing in innovative medical technologies, device components, and regulatory compliance solutions.
FDA ApprovalMedical DevicesRegulatory ComplianceDevice ComponentsInnovation
Omnica Corporation
🇺🇸 United States
198411-50 peopleManufacturer/Service CompanyEstablished brand
ODM manufacturer
Product customization
Multinational enterprise
Key customer
ABBOTT MOLECULAR
Key market
North America
Description
Omnica Corporation, now a part of StarFish Medical, is a premier medical device design and engineering firm headquartered in Irvine, California. Founded in 1984, the company operates from a 25,000-square-foot facility equipped with advanced in-house machining, model making, and rapid prototyping capabilities. As a contract manufacturer and service provider, Omnica specializes in the end-to-end development of complex medical technologies, including diagnostic products, surgical instruments, point-of-care devices, and monitoring equipment. Their multidisciplinary team of experts provides comprehensive services across industrial design, mechanical and electronics engineering, software development, and regulatory affairs consulting. Holding ISO 13485 and FDA certifications, the company supports a diverse clientele ranging from early-stage startups to global MedTech leaders like Medtronic and Abbott. By integrating with StarFish Medical, Omnica leverages expanded North American resources to deliver specialized R&D, feasibility studies, and seamless transitions to manufacturing for high-technology medical products.
Medical Device Design & Development
Medical Device Manufacturing Support
Surgical & therapeutic systems
Surgical & therapeutic systems
Shenzhen Hochuen Technologies Co., Ltd.
🇨🇳 China
20042001-5000 peopleManufacturer/Trading CompanyHigh capacity factory
Established brand
Large enterprise group
OEM manufacturer
Shipments
54
Key customer
EURO CB PHILS
Key market
🇵🇭 Philippines
Review
5
High Quality Medical Device Contract Manufacturing Product Development Service Custom Two Shot Injection Molding Medical$0.99
Customization Wholesale Strong Adhesion Acrylic Clear Medical Tape Die Cut Foam Tape for Medical Device$0.05
ISO13485 Medical Device Cleanroom Manufacturing Factory Custom Thickness OEM Colored Double Sided Coated Adhesive Foam Tape$0.1
Custom Self-Adhesive Industrial PET Biochip Control Panel Sticker Decals Medical Device Labels Processing Service Cutting$0.2
Custom Silicone Rubber Pad Graphic Overlay Adhesive Keyboard Embossed Button Sticker Membrane Switch Keypad for Medical Device$0.02
ISO13485 Cleanroom Die Cut Insulation Pad Adhesive Tapes Two Side Polyurethane Polyomide 2mm Thick Foam Tape for Medical Device$0.2
Medical Device CDMO Manufacturing Plastic Products Test Kit ABS PC PP Injection Molding for IVD and POCT Test Cartridge$0.02
Tamper-Evident Anti-Counterfeiting Security Stickers High-Visibility Warning Industrial Labels Certified Medical Label$0.02
OEM Medical Product PSA Strong Adhesives 3M Custom Die Cutting Round 9448A Electricity Adhesive Masking Tape$0.05
High Quality Removable Adhesive Tape Sticker Customized Fingerboard Medical Self Adhesive Foam Insulation Tape for Automotive$0.02
Medical Parts Moulding Factory Plastic Parts Machining Components Diffusion Bonding Assembly Microfluidic Chip for IVD Products$0.05
Barcode Roll Sticker Custom Chemical Self Adhesive Round Roll Special Shaped Label Paper for Customize Medical Products$0.02
Jiangsu Qianjing Medical Equipment Co., Ltd.
🇨🇳 China
2002201-300 peopleManufacturer/Trading CompanyEstablished brand
OEM manufacturer
Own brand
Product customization
Shipments
462
Key customer
PRAECISO SOLUTIONS
Key market
🇮🇳 India
Review
4.9
Medical Disposable Skin Stapler$1.5
Disposable Circumcision Stapler Suture Device$15
Disposable Linear Cutter Stapler and Loading Units$50
Top Quality Stapler Circumcision Phimosis Treatment Circumcision Surgery$15
Male Circumcision Stapler Kit for Adults$15
Factory Skin Stapler Staples Disposable Skin Stapler and Surgical Staples for Surgical$1.5
Hochuen Medical Technology Co., Ltd.
🇨🇳 China
2015501-1000 peopleManufacturer/Trading CompanyHigh capacity factory
OEM manufacturer
ODM manufacturer
Product customization
Shipments
80
Key customer
TASSO
Key market
🇺🇸 United States
Description
Hochuen Medical Technology Co., Ltd. is a leading global OEM, ODM, and CDMO manufacturer specializing in medical disposables and devices for the life sciences, IVD, and drug delivery sectors. Headquartered in Shenzhen, China, with a significant international presence including offices in Los Angeles and Singapore, the company operates advanced manufacturing facilities in Malaysia and China. With a workforce of 501 to 1,000 employees, Hochuen provides end-to-end turnkey services ranging from R&D and rapid prototyping to high-volume production. Their extensive technical capabilities include precision injection molding, microfluidic chip fabrication, die-cutting, CNC machining, and specialized bonding techniques such as laser and ultrasonic welding. The company is well-equipped for complex medical manufacturing, featuring Class 10K-100K cleanrooms and GMP-compliant facilities. Their product portfolio encompasses biomedical consumables, medical wearables, biosensors, and reagent packaging. Hochuen Medical is FDA registered and holds ISO 13485, ISO 14001, and GMP certifications, serving over 250 global clients including major industry leaders in diagnostics and medical technology.
Custom Die Cutting Self Adhesive EVA Foam Gasket for Medical Use$0.02
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Qinhuangdao Huisianpu Medical Systems Inc.
🇨🇳 China
2011101-200 peopleManufacturer/Trading CompanyOEM manufacturer
ODM manufacturer
Product customization
Patented technology
Shipments
7
Key customer
WELLTEC
Key market
🇩🇪 Germany
Review
2.4
Best Choice Professional Medical Devices Optimal Magnetic Therapy Physical Therapy Machine for Medical Treatment$900
Professional Medical Devices for Rehabilitation and Physical Therapy Quality Guaranteed for Bone Improvement on Sale$900
Pulse Magnetic Infrared Therapy Device for Microcirculation Repair Physical Therapy Equipment for Body Leg PMR Medical Equipment$900
FDA-Certified Home Use PEMF Mat Certified Household Medical Device for Pain Relief Sleep & Detox Magnetic Therapy Device$450
Portable Medical Grade PEMF Therapy Device Exclusive System Physical Therapy Equipment for Joint Pain Relief and Improved Sleep$249
No Side Effect Pemf Magnetic Therapy Device Sleep Aid for Hand Lower Limbs Arthritis Physiotherapy Physical Therapy Equipment$900
2025 Portable High Potential Therapy Machine for Constipation Effective Physical Therapy Equipment$900
Factory Manufacture Anti-Aging Physiotherapy Rehabilitation Equipment Imported Curing Neck Pain Physical Therapy Gear$500
Large-Capacity 90-Litre Pet Dryer Pulsed Electromagnetic Field (PEMF) Therapy Intelligent Temperature Veterinary Instrument$200
AM6200 Pet Monitor One-Button Operation Measures ECG Heart Rate Non-Invasive Blood Pressure Blood Oxygen Saturation Pulse Rate$260
Hot Sale Portable Home Physiotherapy Equipment Top Physical Therapy Gear for Effective Joint Pain Relief$249
Home Painless Veterinary Instrument Magnetic Therapy Equipment for Pets Immunity & Gastrointestinal Conditioning$500
Foshan HCT Medical Equipment Co., Ltd.
🇨🇳 China
201351-100 peopleManufacturerOEM manufacturer
ODM manufacturer
Product customization
High product rating
Shipments
274
Key customer
BOXOUT
Key market
🇺🇸 United States
Review
5
HCT-9124G OEM Medical Health Care Aluminum Lightweight Rollator and Rehabilitation Walker 2 in 1 Rollator for Elderly$70
High Quality Stable Home Care Physical Therapy Equipment for Adult Folding Upright Walker Wheel Walker With Cane Holder$72
High Quality Super Sturdy Stable Home Care Smooth -Rolling Aluminum Patient for Adult Folding Rollator Walker With Cane Holder$59
Popular Product Aluminum Foldable Mobility Aid Steerable Rollator Walker Handicapped Scooter for Senior$40
Light Weight Carbon Fiber Rollator$205
Ningbo Five Continents Medical Instrument Co., Ltd.
🇨🇳 China
200451-100 peopleManufacturer/Trading CompanyEstablished brand
OEM manufacturer
ODM manufacturer
Low MOQ
Shipments
30
Key customer
PFO
Key market
🇪🇪 Estonia
Review
4.9
Surgical Device Disposable Electrosurgical Medical Blue Esu Pencil$0.5
Innovative Disposable Wound Irrigator Arthroplasty Medical Device Technology$21
Qualified Medical Care Device Finger Splint Orthopedic Splint$0.5
Disposable Surgical Lavage C Wound Cleaner Arthroplasty Medical Device$21
Customized Esu Medical Cables Disposable Surgical Pen Health Medical High Quality Sterilized Disposable Electrosurgical Pencil$0.6
Medical Device Pulse Lavage in Arthroplasty Surgery and Truma Cases$10
Medical Equipment Esu Pencil Surgical Instrument$0.5
Disposable Pulse Lavage System Surgical Wound Cleaner Arthroplasty Medical Device Fast$21
High Frequency Medical Devices Diathermy Pencil Manual Unipolar Electrodes Electrosurgical Pencil$0.5
Disposable Pulse Lavage System Irrigator Surgical Wound Cleaner Arthroplasty Medical Device$21
Disposable Surgical Lavage System Irrigation Device Wound Cleaner Arthroplasty Medical Device Fast$21
Medical Multi-Functional Orthopedic Arthroscopy Shaver Blade$23
Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd.
🇨🇳 China
2013501-1000 peopleManufacturer/Trading CompanyHigh capacity factory
Low MOQ
High-tech enterprise
Industry association member
Shipments
337
Key customer
FUTUMEDICA
Key market
🇨🇴 Colombia
Review
4.8
SONOSAT-F01LT Smart Wifi SPO2 Portable Fingertip Pulse Oximeter for Home Use$19
CPV CDV ICH Ab$30
SONOSAT-F02LP Economical Smart Digital Portable Finger Pulse Oximeter Wireless Fingertip Pulse Oximeter Wifi for Household$12
Kernel Medical Equipment Co., Ltd
🇨🇳 China
1997501-1000 peopleManufacturer/Trading CompanyHigh capacity factory
Established brand
OEM manufacturer
ODM manufacturer
Shipments
392
Key customer
DOLPHIN
Key market
🇮🇳 India
Review
4.8
KN-9000B Medical Woods Lamp Skin Analysis Medical Dermatology Device$249
Professional Kernel Medical LED Photodynamic Therapy Device KN-7000D with Medical CE TGA$3500
KN-9000B Medical Magnifier Woods Lamp Skin Analysis Medical Dermatology Examination Device Wood's Lamp$249
Professional Medical CE Approved Digital 4k Colposcope Video Vaginal Medical Colposcope Device for Gynecology$2300
For Kernel Medical Equipment's Effective Phototherapy Ultraviolet Rays Treatment for Vitiligo Household Medical Device$210
Professional KN-5000C Medical Equipment 308 Excimer Laser Machine for Psoriasis Vitiligo Treatment Clinic Medical Device$1800
Dermatology Beauty Device Wood Lamp Portable Dialysis Machine medical Skin Analyzer Facial medical woods lamp KN-9000c$99
Dermatology Beauty Device Wood Lamp Portable Dialysis Machine Medical Skin Analyzer Facial Medical Woods Lamp KN-9000c$99
Class IIa Medical Devices Medically CE LED Light Therapy Facial Certified for Acne, Psoriasis, Wound Healing KN-7000A$4580
Hair Growth System LED Therapy for Scalp Care Professional Medical LED Light Therapy Device Medical PDT Red Blue Yellow Infrared$4580
Kernel Medical Grade Red Light Therapy Device 4 LED Therapy Brightness Adjustable High Power Medical Grade PDT Machine for Skin$3500
Kernel Medical Digital Equipment Coloposcope CE Medical Video Camera Colposcope for Gynecology Vaginal Examination$2300
Dongguan Aidisy Machinery & Electronic Equipment Co., Ltd.
🇨🇳 China
200651-100 peopleManufacturer/Trading CompanyOEM manufacturer
Patented technology
Multinational enterprise
ODM manufacturer
Shipments
79
Key customer
COMPASS HEALTH BRANDS
Key market
🇺🇸 United States
Review
5
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