DeviceEstablishmentPulse: Foreign establishment, page 2 of 4
Records 51 to 200 of the 500 newest listed for this hub. Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
| Record | Role | New listings | Devices |
|---|---|---|---|
| Shanghai Link Instruments Co.,Ltd | Manufacturer | 3 | Ophthalmoscope, Battery-Powered; Frame, Trial, Ophthalmic; Topographer, Corneal, Ac-Powered |
| Eizo Corporation | Manufacturer | 3 | Display, Diagnostic Radiology; Laparoscope, General & Plastic Surgery; Digital Pathology Display |
| Siemens Healthineers Ltd. | Manufacturer | 7 | Catheter, Ultrasound, Intravascular; Biopsy Needle Guide Kit; Automated Radiological Image Processing Software; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; Transducer, Ultrasonic, Diagnostic |
| Shirakawa Olympus Co., Ltd. | Manufacturer | 6 | Transducer, Ultrasonic, Diagnostic; Endoscopic Ultrasound System, Gastroenterology-Urology; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Endoscope, Accessories, Narrow Band Spectrum |
| Conavi Medical Inc | Specification developer (outsources manufacturing) | 3 | System, Imaging, Optical Coherence Tomography (Oct); System, Imaging, Pulsed Echo, Ultrasonic; Catheter, Ultrasound, Intravascular |
| Epic International (Thailand) Co., Ltd. | Manufacturer | 6 | Controller, Infusion, Intravascular, Electronic; Set, Administration, Intravascular; Pump, Infusion, Elastomeric; Set, I.V. Fluid Transfer; Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| DRTECH Corporation | Manufacturer | 4 | Interventional Fluoroscopic X-Ray System; Image-Intensified Fluoroscopic X-Ray System, Mobile; System, X-Ray, Fluoroscopic, Image-Intensified; System, X-Ray, Stationary |
| Spectrum Medical Ltd | Manufacturer | 3 | Control, Pump Speed, Cardiopulmonary Bypass; Console, Heart-Lung Machine, Cardiopulmonary Bypass; Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type |
| Boditech Med Inc. | Manufacturer | 9 | Antigens, All Groups, Streptococcus Spp.; Norovirus Serological Reagent; Radioimmunoassay, Human Growth Hormone; Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine; Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus; Enzyme Linked Immunoabsorbent Assay, Rotavirus; Albumin, Antigen, Antiserum, Control; Radioimmunoassay, C-Peptides Of Proinsulin; Radioimmunoassay, Total Triiodothyronine |
| Gcmedica Enterprise Ltd.(Wuxi) | Manufacturer | 3 | Applicator, Vaginal; Speculum, Vaginal, Nonmetal; Nebulizer, Medicinal, Non-Ventilatory (Atomizer) |
| Immunodiagnostic Systems Ltd. | Manufacturer | 4 | Extractable Antinuclear Antibody, Antigen And Control; Anti-Ss-A Ro60 Autoantibodies; Anti-Ss-A 52 Autoantibodies; Radioimmunoassay, Estradiol |
| United Orthopedic Corp. | Manufacturer | 4 | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| United Orthopedic Corporation | Manufacturer | 4 | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Shenzhen Root Innovation Technology Co., Ltd. | Manufacturer | 4 | Pump, Breast, Powered; Pump, Portable, Aspiration (Manual Or Powered); Shield, Nipple |
| Siemens Shenzhen Magnetic Resonance Ltd. | Manufacturer | 5 | System, Nuclear Magnetic Resonance Imaging; Coil, Magnetic Resonance, Specialty; System, Nuclear Magnetic Resonance Spectroscopic |
| Shandong Moonlight Electronics Tech Co.,Ltd. | Manufacturer | 3 | Device, Rebreathing; Marker, Skin; Generator, Oxygen, Portable |
| Boen Healthcare Co., Ltd. | Specification developer (outsources manufacturing) | 125 | Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Cup, Prophylaxis; Connector, Airway (Extension); Silicone Hydrogel For Scar Management; Device, Incontinence, Urosheath Type, Non-Sterile; Clinical Electronic Thermometer; Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use; Drape, Adhesive, Aerosol; Accessories, Retractor, Dental; Brush, Cleaning, Tracheal Tube |
| Shenzhen Sany Pioneer Technology Co., Ltd. | Manufacturer | 5 | Set, Tubing And Support, Ventilator (W Harness); Dilator, Nasal; Device, Anti-Snoring; Device, Jaw Repositioning; Ventilator, Non-Continuous (Respirator) |
| AOMORI OLYMPUS CO., LTD. Kuroishi Site | Manufacturer | 6 | Forceps, Biopsy, Electric; Gastroscope And Accessories, Flexible/Rigid; Electrode, Electrosurgical, Active, Urological; Instrument, Ultrasonic Surgical; Electrosurgical, Cutting & Coagulation & Accessories; Hemostatic Metal Clip For The Gi Tract |
| Joytech Healthcare Co., Ltd. | Manufacturer | 3 | System, Measurement, Blood-Pressure, Non-Invasive |
| Rens Medcare (Cambodia) Co.,Ltd. | Manufacturer | 3 | System, Measurement, Blood-Pressure, Non-Invasive |
| Aizu Olympus Co., Ltd. | Manufacturer | 4 | Endoscope, Accessories, Narrow Band Spectrum; Bronchoscope (Flexible Or Rigid); Gastroscope And Accessories, Flexible/Rigid |
| Mikron Makina Sanayi Ve Ticaret Ltd. Sti. | Manufacturer | 3 | Screw, Fixation, Bone; Washer, Bolt Nut; Plate, Fixation, Bone |
| Fujifilm Corporation | Manufacturer | 14 | System, Image Processing, Radiological; Automated Radiological Image Processing Software; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; Led Light Source; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Endoscope, Accessories, Image Post-Processing For Color Enhancement; Colonoscope And Accessories, Flexible/Rigid; Endoscopic Light-Projecting Measuring Device |
| FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office | Manufacturer | 10 | Gastrointesinal Lesion Software Detection System; Led Light Source; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Endoscope, Accessories, Image Post-Processing For Color Enhancement; Colonoscope And Accessories, Flexible/Rigid; Endoscopic Light-Projecting Measuring Device; Enteroscope And Accessories; Endoscope, Accessories, Narrow Band Spectrum; System, Image Processing, Radiological; Automated Radiological Image Processing Software |
| Sterilance Medical (Suzhou) Inc. | Manufacturer | 3 | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature; Multiple Use Blood Lancet For Single Patient Use Only |
| Vivachek Biotech (Hangzhou) Co., Ltd | Manufacturer | 12 | Enzyme Immunoassay, Phencyclidine; Test, Amphetamine, Over The Counter; Test, Barbiturate, Over The Counter; Test, Propoxyphene, Over The Counter; Test, Opiates, Over The Counter; Test, Cannabinoid, Over The Counter; Test, Methadone, Over The Counter; Test, Methamphetamine, Over The Counter; Test, Benzodiazepine, Over The Counter; Test, Tricyclic Antidepressants, Over The Counter |
| Mast Group Ltd. | Manufacturer | 3 | Susceptibility Test Discs, Antimicrobial |
| Guangdong Titan Smart Electrical Appliance Co., Ltd. | Manufacturer | 8 | Splint, Clavicle; Massager, Therapeutic, Electric; Bath, Hydro-Massage; Lamp, Infrared, Therapeutic Heating; Brush, Dermabrasion, Powered; Toothbrush, Powered; Massager, Therapeutic, Manual; Mask, Scavenging |
| Mediclus Co., Ltd | Manufacturer | 6 | Liner, Cavity, Calcium Hydroxide; Syringe, Restorative And Impression Material; Powder, Porcelain; Agent, Tooth Bonding, Resin; Sealant, Pit And Fissure, And Conditioner; Cement, Dental |
| Baxter Innovations & Business Solutions Pvt. Ltd. | Specification developer (outsources manufacturing) | 4 | System, Image Processing, Radiological; Monitor, Breathing Frequency; System, Network And Communication, Physiological Monitors; Bed, Ac-Powered Adjustable Hospital |
| L&K Biomed Co.,Ltd. | Manufacturer | 7 | Intervertebral Fusion Device With Bone Graft, Cervical; Appliance, Fixation, Spinal Intervertebral Body; Thoracolumbosacral Pedicle Screw System; Appliance, Fixation, Spinal Interlaminal; Plate, Fixation, Bone |
| Densol International (Private) Limited | Manufacturer | 35 | Mirror, Mouth; Bone Mill; Elevator, Surgical, Dental; Forceps, Articulation Paper; Forceps, Rubber Dam Clamp; Knife, Periodontic; Holder, Needle, Gastroenterologic; Carver, Dental Amalgam, Operative; Probe, Periodontic; Handle, Scalpel |
| Shenzhen New Industries Biomedical Engineering Co.,Ltd | Manufacturer | 4 | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use; Analyzer, Chemistry (Photometric, Discrete), For Clinical Use; System, Test, Vitamin D |
| Corin Limited | Manufacturer | 5 | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Hip, Hemi-, Femoral, Metal; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate |
| Samsung Electronics Co., Ltd. Mobile eXperience Business | Manufacturer | 3 | Over-The-Counter Device To Assess Risk Of Sleep Apnea; Air-Conduction Hearing Aid Software; Audiometer |
| Shenzhen Chuangtong Yigou Technology Co., Ltd | Manufacturer | 3 | Lamp, Infrared, Therapeutic Heating; Light Based Over The Counter Wrinkle Reduction; Over-The-Counter Powered Light Based Laser For Acne |
| Beijing Winkonlaser Technology Limited | Manufacturer | 5 | Stimulator, Muscle, Powered, For Muscle Conditioning; Powered Laser Surgical Instrument; Powered Laser Surgical Instrument With MicrobeamFractional Output |
| Philips Medical Systems Technologies Ltd. | Manufacturer | 4 | System, X-Ray, Tomography, Computed; Automated Radiological Image Processing Software; System, Image Processing, Radiological |
| Shenzhen Mindray Bio-Medical Electronics Co.,LTD | Specification developer (outsources manufacturing) | 39 | Detector And Alarm, Arrhythmia; Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm); Non-Normalizing Quantitative Electroencephalograph Software; Analyzer, Gas, Oxygen, Gaseous-Phase; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Stimulator, Nerve, Peripheral, Electric; Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.); System, Measurement, Blood-Pressure, Non-Invasive; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms); Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) |
| Philips India Limited - Radiology Informatics, Clinical Informatics, Patient Care Informatics Business Units | Specification developer (outsources manufacturing) | 4 | System, X-Ray, Tomography, Computed; Automated Radiological Image Processing Software; System, Image Processing, Radiological |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Manufacturer | 39 | Detector And Alarm, Arrhythmia; Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm); Non-Normalizing Quantitative Electroencephalograph Software; Analyzer, Gas, Oxygen, Gaseous-Phase; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Stimulator, Nerve, Peripheral, Electric; Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.); System, Measurement, Blood-Pressure, Non-Invasive; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms); Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) |
| Yadu Medical (Henan) Co., Ltd | Manufacturer | 4 | Tray, Surgical, Instrument; Kit, Surgical Instrument, Disposable; Gown, Surgical; Speculum, Vaginal, Nonmetal |
| Philips India Limited - Image Guided Therapy Systems Business Unit | Specification developer (outsources manufacturing) | 3 | Interventional Fluoroscopic X-Ray System; System, X-Ray, Fluoroscopic, Image-Intensified; Image-Intensified Fluoroscopic X-Ray System, Mobile |
| Hangzhou AGS MedTech Co., Ltd. | Manufacturer | 4 | Hemostatic Metal Clip For The Gi Tract; Stents, Drains And Dilators For The Biliary Ducts; Dilator, Esophageal |
| Micro-Energy Medical Technology Co., Ltd. | Manufacturer | 4 | Accessories, Catheter; Guide, Needle, Surgical; Powered Laser Surgical Instrument; Massager, Therapeutic, Electric |
| GE Medical Systems, Israel Ltd. | Specification developer (outsources manufacturing) | 4 | Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; Automated Radiological Image Processing Software; Twister, Brace Setting |
| Beijing Spiritlaser Science & Technology Co., Ltd. | Manufacturer | 3 | Powered Laser Surgical Instrument; Stimulator, Muscle, Powered, For Muscle Conditioning; Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Shenzhen Hengbosi Industrial Co., Ltd. | Manufacturer | 9 | Stimulator, Muscle, Powered, For Muscle Conditioning; Stimulator, Muscle, Powered; Stimulator, Nerve, Transcutaneous, For Pain Relief; Pad, Heating, Powered; Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Acheron Instruments (Pvt.) Ltd. | Manufacturer | 134 | Laryngoscope, Non-Rigid; Speculum, Rectal; Forceps, Ent; Marker, Skin; Catheter, Nasopharyngeal; Chisel, Bone, Surgical; Carver, Wax, Dental; Drum, Eye Knife Test; Dilator, Tracheal; Excavator, Dental, Operative |
| Macrolux Medical Technology Co., Ltd. | Manufacturer | 6 | Cystoscope And Accessories, Flexible/Rigid; Ureteroscope And Accessories, Flexible/Rigid; Hysteroscope Accessories; Bronchoscope (Flexible Or Rigid); Forceps, Biopsy, Non-Electric; Forceps, Biopsy, Gynecological |
| Depuy (Ireland) | Manufacturer | 5 | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Shoulder Prosthesis, Reverse Configuration |
| Nihon Kohden Corp. | Specification developer (outsources manufacturing) | 5 | Standard Polysomnograph With Electroencephalograph; Stimulator, Photic, Evoked Response; Full-Montage Standard Electroencephalograph; Non-Normalizing Quantitative Electroencephalograph Software; Tape And Bandage, Adhesive |
| ShenB Co Ltd | Manufacturer | 5 | Electrosurgical, Cutting & Coagulation & Accessories; Stimulator, Transcutaneous Electrical, Aesthetic Purposes; Massager, Vacuum, Radio Frequency Induced Heat |
| Draegerwerk AG & Co. KGaA | Manufacturer | 5 | Support, Breathing Tube; Warmer, Infant Radiant; Bilirubin (Total And Unbound) In The Neonate Test System; Ventilator, Continuous, Facility Use; Gas-Machine, Anesthesia |
| Digital Dental Depot Limited | Manufacturer | 5 | Device, Jaw Repositioning; Device, Anti-Snoring |
| Nihon Kohden Tomioka Corporation | Manufacturer | 4 | Standard Polysomnograph With Electroencephalograph; Stimulator, Photic, Evoked Response; Full-Montage Standard Electroencephalograph; Non-Normalizing Quantitative Electroencephalograph Software |
| Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center | Specification developer (outsources manufacturing) | 5 | Tape And Bandage, Adhesive; Standard Polysomnograph With Electroencephalograph; Stimulator, Photic, Evoked Response; Full-Montage Standard Electroencephalograph; Non-Normalizing Quantitative Electroencephalograph Software |
| Cmt Health PTE. Ltd. | Specification developer (outsources manufacturing) | 9 | Needle, Hypodermic, Single Lumen; Syringe, Piston; Syringe, Antistick; Low Dead Space Piston Syringe; System, Blood Collection, Vacuum-Assisted, Manual |
| Assure Tech. (Hangzhou) Co., Ltd. | Manufacturer | 3 | Sperm, Antigen, Antiserum, Control; Over-The-Counter Covid-19 Antigen Test; Nitroprusside, Ketones (Urinary, Non-Quant.) |
| Assure Tech. (Hangzhou) Co., Ltd. | Manufacturer | 3 | Sperm, Antigen, Antiserum, Control; Over-The-Counter Covid-19 Antigen Test; Nitroprusside, Ketones (Urinary, Non-Quant.) |
| Nanoentek Inc | Manufacturer | 3 | Radioimmunoassay, Total Triiodothyronine; Counter, Differential Cell; Multi-Analyte Controls, All Kinds (Assayed) |
| Nanoentek Inc | Specification developer (outsources manufacturing) | 3 | Counter, Differential Cell; Multi-Analyte Controls, All Kinds (Assayed); Radioimmunoassay, Total Triiodothyronine |
| Beijing Konted Medical Technology Co., Ltd | Manufacturer | 3 | System, Imaging, Pulsed Doppler, Ultrasonic; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Echo, Ultrasonic |
| The Beauty Tech Group Ltd | Specification developer (outsources manufacturing) | 3 | Over-The-Counter Powered Light Based Laser For Acne; Light Based Over The Counter Wrinkle Reduction; Laser, Comb, Hair |
| Dong Guan Jia Shuan Industrial Co., Ltd | Manufacturer | 5 | Cushion, Flotation; Pad, Heating, Powered; Mattress, Air Flotation, Alternating Pressure; Hemorrhoid Prevention Pressure Wedge; Massager, Therapeutic, Electric |
| Hubei Guarddent Medical Technology Co.,Ltd | Manufacturer | 10 | Pusher, Band, Orthodontic; Dental Barriers And Sleeves; Mixer, Cement, For Clinical Use; Cleaner, Denture, Mechanical; Instrument, Manual, Surgical, General Use; Unit, Operative Dental, Accessories; Syringe, Irrigating (Dental); Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear); Handle, Scalpel; Tape, Measuring, Rulers And Calipers |
| Changzhou Newmed Micro-Medtech Co., Ltd. | Manufacturer | 3 | Accessories, Catheter; Snare, Non-Electrical; Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt |
| Beijing Infervision Healthcare Medical Technology Co., Ltd. | Manufacturer | 3 | Automated Radiological Image Processing Software |
| Anqing Clean Dental Instrument Technology Co.,Ltd | Manufacturer | 47 | Cotton, Roll; Point, Abrasive; Instruments, Dental Hand; Instrument, Filling, Plastic, Dental; Cover, Shoe, Operating-Room; Bur, Dental; Wheel, Polishing Agent; Accessory, Surgical Apparel; Tray, Impression, Preformed; Board, Arm (With Cover), Non-Sterile |
| Taiwan Surgical Corporation | Manufacturer | 3 | Applier, Surgical, Clip; Clip, Implantable; Laparoscope, General & Plastic Surgery |
| Pegavision Corporation | Manufacturer | 4 | Lenses, Soft Contact, Daily Wear; Lens, Contact, (Disposable) |
| Pegavision Corporation-Daxi | Manufacturer | 4 | Lenses, Soft Contact, Daily Wear; Lens, Contact, (Disposable) |
| Xiamen Weiyou Intelligent Technology Co.,Ltd | Manufacturer | 4 | Massager, Powered Inflatable Tube; Pack, Hot Or Cold, Water Circulating; Lamp, Infrared, Therapeutic Heating |
| Foshan Pingchuang Medical Technology Co., Ltd | Manufacturer | 4 | Media, Coupling, Ultrasound; Lubricant, Personal; Enema Kit; Douche Apparatus, Vaginal, Therapeutic |
| FUJIFILM Healthcare Manufacturing Corporation Sano Office | Manufacturer | 8 | Led Light Source; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Endoscope, Accessories, Image Post-Processing For Color Enhancement; Colonoscope And Accessories, Flexible/Rigid; Endoscopic Light-Projecting Measuring Device; Enteroscope And Accessories; Endoscope, Accessories, Narrow Band Spectrum; Bronchoscope (Flexible Or Rigid) |
| Endorobotics Co., Ltd. | Manufacturer | 3 | Colonoscope And Accessories, Flexible/Rigid; System, Surgical, Computer Controlled Instrument; Gastroscope And Accessories, Flexible/Rigid |
| Materialise Colombia S.A.S | Manufacturer | 3 | Shoulder Arthroplasty Implantation System; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Signature Orthopaedics PTY Limited | Manufacturer | 12 | Prosthesis, Hip, Femoral, Resurfacing; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component); Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
| Shantou Institute Of Ultrasonic Instruments Co., Ltd. | Manufacturer | 3 | System, X-Ray, Mobile; System, Image Processing, Radiological; Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Shantou Institute Of Ultrasonic Instruments Co., Ltd. | Manufacturer | 3 | System, X-Ray, Mobile; System, Image Processing, Radiological; Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Waldemar Link GmbH & Co. KG | Manufacturer | 4 | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented |
| Dongguan Paidaxing Technology Co., Ltd | Manufacturer | 3 | Massager, Therapeutic, Electric; Pad, Heating, Powered; Lamp, Infrared, Therapeutic Heating |
| Savfe Co., Ltd. | Manufacturer | 3 | System, Image Processing, Radiological; System, X-Ray, Fluoroscopic, Image-Intensified; Interventional Fluoroscopic X-Ray System |
| Guangzhou Wondfo Biotech Co., Ltd. | Manufacturer | 11 | Test, Propoxyphene, Over The Counter; Test, Amphetamine, Over The Counter; Test, Opiates, Over The Counter; Enzyme Immunoassay, Phencyclidine; Test, Cannabinoid, Over The Counter; Test, Barbiturate, Over The Counter; Test, Methamphetamine, Over The Counter; Test, Cocaine And Cocaine Metabolites, Over The Counter; Test, Benzodiazepine, Over The Counter; Test, Tricyclic Antidepressants, Over The Counter |
| Guangzhou Wondfo Biotech Co., Ltd. | Manufacturer | 11 | Test, Propoxyphene, Over The Counter; Test, Amphetamine, Over The Counter; Test, Opiates, Over The Counter; Enzyme Immunoassay, Phencyclidine; Test, Cannabinoid, Over The Counter; Test, Barbiturate, Over The Counter; Test, Methamphetamine, Over The Counter; Test, Cocaine And Cocaine Metabolites, Over The Counter; Test, Benzodiazepine, Over The Counter; Test, Tricyclic Antidepressants, Over The Counter |
| Qinhuangdao Audental Metal Technology Co., Ltd. | Manufacturer | 7 | Restoration, Porcelain; Restoration, Base Metal; Restoration, Porcelain-Fused-To-Metal; Denture Preformed (Partially Prefabricated Denture); Crown, Preformed; Dentures, Partial; Restoration, Noble Metal |
| Gc Dental Products Corp. | Manufacturer | 3 | Material, Tooth Shade, Resin; Agent, Tooth Bonding, Resin; Sealant, Pit And Fissure, And Conditioner |
| Zhejiang Decans Medical Devices Co.,Ltd. | Manufacturer | 13 | Appliance, Fixation, Spinal Intervertebral Body; Intervertebral Fusion Device With Bone Graft, Lumbar; Rod, Fixation, Intramedullary And Accessories; Orthosis, Spine, Plate, Laminoplasty, Metal; Fastener, Fixation, Nondegradable, Soft Tissue; Appliance, Fixation, Spinal Interlaminal; Posterior Cervical Screw System; Intervertebral Fusion Device With Integrated Fixation, Cervical; Thoracolumbosacral Pedicle Screw System; Intervertebral Fusion Device With Bone Graft, Cervical |
| Apothecaries Sundries Mfg Pvt Ltd | Manufacturer | 26 | Shoe, Cast; Binder, Abdominal; Assembly, Thigh/Knee/Shank/Ankle/Foot, External; Attachment, Commode, Wheelchair; Binder, Elastic; Bag, Ice; Assembly, Knee/Shank/Ankle/Foot, External; Orthosis, Rib Fracture, Soft; Orthosis, Cervical; Orthosis, Cervical-Thoracic, Rigid |
| Zhangjiagang New Fellow Med Co., Ltd. | Manufacturer | 16 | Stretcher, Wheeled; Chair, With Casters; Board, Cardiopulmonary; Stool, Operating-Room; Splint, Traction; Stretcher, Patient Restraint; Stretcher, Wheeled, Powered; Stretcher, Hand-Carried; Splint, Hand, And Components; Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Siemens Healthineers Ltd. | Specification developer (outsources manufacturing) | 6 | Biopsy Needle Guide Kit; Automated Radiological Image Processing Software; System, Imaging, Pulsed Doppler, Ultrasonic; Catheter, Ultrasound, Intravascular; System, Imaging, Pulsed Echo, Ultrasonic; Transducer, Ultrasonic, Diagnostic |
| Kbbio Co., Ltd. | Manufacturer | 3 | Respirator, Surgical; Generator, Oxygen, Portable; Vaginal Hydrogel Packing System |
| Depuy Intl., Ltd. | Manufacturer | 4 | Bone Cement; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Bone Cement, Antibiotic; Prosthesis, Hip, Hemi-, Femoral, Metal |
| Alpha AI Co., Ltd. | Manufacturer | 4 | Thoracolumbosacral Pedicle Screw System; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body |
| Wuhan Landing Intelligence Medical Co.,Ltd | Manufacturer | 5 | Pap Smear Kit; Preservative, Cytological; Slides, Microscope; Stainer, Tissue, Automated; Cytology Kit |
| Dongguan Letme Medical Technology Co., Ltd. | Manufacturer | 3 | Light Based Over-The-Counter Hair Removal |
| Hlb Life Science Co., Ltd. | Manufacturer | 3 | Low Dead Space Piston Syringe; Needle, Hypodermic, Single Lumen; Syringe, Piston |
| Edgecare Inc. | Manufacturer | 4 | Automated Radiological Image Processing Software; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Echo, Ultrasonic; Media, Coupling, Ultrasound |
| Huizhou Videya Technology Co., Ltd. | Manufacturer | 3 | Intraoral Camera; Handpiece (Brace), Drill; Mixer, Cement, For Clinical Use |
| WEERO Co., Ltd. | Manufacturer | 3 | Pad, Heating, Powered; Stimulator, Nerve, Transcutaneous, For Pain Relief; Stimulator, Muscle, Powered |
| Current Health Ltd | Specification developer (outsources manufacturing) | 6 | Spirometer, Diagnostic; Oximeter; System, Network And Communication, Physiological Monitors; Continuous Measurement Thermometer; Monitor, Breathing Frequency; Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Alma Lasers Ltd. | Manufacturer | 5 | Light Based Over The Counter Wrinkle Reduction; Over-The-Counter Powered Light Based Laser For Acne; Medical Device Data System; Massager, Therapeutic, Electric; Laser, Comb, Hair |
| Suzhou Zenith Vascular Scitech Limited | Manufacturer | 7 | Catheter, Percutaneous; Catheter, Percutaneous, Neurovasculature; Catheter, Continuous Flush; Catheter, Thrombus Retriever; Guide, Wire, Catheter, Neurovasculature; Wire, Guide, Catheter |
| Liaoning Xinaite Technology Co.,Ltd | Manufacturer | 3 | Material, Impression Tray, Resin; Agent, Polishing, Abrasive, Oral Cavity; Alloy, Other Noble Metal |
| Medline Industries, LP - Mexicali (MXC) | Manufacturer | 4 | Tubes, Vials, Systems, Serum Separators, Blood Collection; Set, Administration, Intravascular; Lavage, Jet; Speculum, Vaginal, Nonmetal |
| Alton Shanghai Medical Instruments Co Ltd | Manufacturer | 3 | Device, Measuring, For Panendoscope; Attachment, Teaching, For Endoscope; Biliary Catheter For Irrigation And Contrast Injection, Exempt |
| Wuhan United Imaging Healthcare Co.,Ltd. | Manufacturer | 8 | System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; Automated Radiological Image Processing Software; Transducer, Ultrasonic, Diagnostic |
| Puli Healthcare (Thailand) Co., Ltd. | Manufacturer | 29 | Gauze / Sponge,Nonresorbable For External Use; Drape, Surgical, Exempt; Depressor, Tongue, Non-Surgical; Instrument, Surgical, Disposable; Bandage, Cast; Brush, Scrub, Operating-Room; Needle, Acupuncture, Single Use; Handle, Scalpel; Bandage, Elastic; Mask, Oxygen |
| Signature Orthopaedics Europe Ltd | Manufacturer | 4 | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Avita Corp (Thailand) Co., Ltd. | Manufacturer | 5 | Pad, Heating, Powered; Detectors And Removers, Lice, (Including Combs); Clinical Electronic Thermometer; Nebulizer, Medicinal, Non-Ventilatory (Atomizer); Irrigator, Powered Nasal |
| FUJIFILM Corporation Medical Systems Research & Development Center Minamiaoyama | Manufacturer | 3 | Lung Computed Tomography System, Computer-Aided Detection; System, Image Processing, Radiological; Automated Radiological Image Processing Software |
| Deepintec Scientific Co., Ltd | Manufacturer | 6 | Wire, Guide, Catheter; Guide, Wire, Catheter, Neurovasculature |
| Shenzhen Lincond Technology Co.,Ltd. | Manufacturer | 4 | Lamp, Infrared, Therapeutic Heating; Pad, Eye; Massager, Therapeutic, Electric; Pack, Hot Or Cold, Reusable |
| Hengshui Shuntai Kangyuan Medical Equipment Co.,Ltd | Manufacturer | 11 | Chair And Table, Medical; Table, Examination, Medical, Powered; Stretcher, Wheeled; Bed, Ac-Powered Adjustable Hospital; Cane; Stretcher, Hand-Carried; Chair, With Casters; Stand, Infusion; Walker, Mechanical; Table, Mechanical |
| Sonoscape Medical Corp. | Manufacturer | 3 | System, Imaging, Pulsed Doppler, Ultrasonic; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Echo, Ultrasonic |
| Sonoscape Medical Corp. | Manufacturer | 3 | System, Imaging, Pulsed Doppler, Ultrasonic; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Echo, Ultrasonic |
| CHISON Medical Technologies Co., Ltd. | Manufacturer | 3 | System, Imaging, Pulsed Echo, Ultrasonic; System, Imaging, Pulsed Doppler, Ultrasonic; Transducer, Ultrasonic, Diagnostic |
| Foshan Fricheer Medical Technology Co.,Ltd | Manufacturer | 7 | Adaptor, Hygiene; Device, Patient Transfer, Powered; Stool, Operating-Room; Attachment, Commode, Wheelchair; Crutch; Device, Transfer, Patient, Manual; Adult Portable Bed Rails For Medical Purposes |
| Neurophet, Inc. | Manufacturer | 4 | System, Image Processing, Radiological; Automated Radiological Image Processing Software |
| Arck Technologies Innovations Pvt Ltd | Manufacturer | 4 | Labware, Assisted Reproduction, Exempt; Container, Specimen, Non-Sterile; Container, Specimen, Sterile; Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
| Guangzhou Nanqixing Nonwoven Co., Ltd. | Manufacturer | 5 | Mask, Scavenging; Accessory, Surgical Apparel; Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua; Respirator, Surgical; Non-Surgical Gown |
| Dongguan Quanding Medical Supplies Co., Ltd | Manufacturer | 7 | Unit, Heating, Powered; Bandage, Elastic; Set, Tubing And Support, Ventilator (W Harness); Irrigator, Powered Nasal; Cable, Electrode; Pad, Heating, Powered; Unit, Chilling |
| Hangzhou Shining3d Dental Technology Co., Ltd | Manufacturer | 3 | Crown And Bridge, Temporary, Resin; Additively Manufactured, Preformed, Resin Denture Tooth; Material, Tooth Shade, Resin |
| Shenzhen Ctlite Technology Co.,Ltd | Manufacturer | 4 | Massager, Therapeutic, Electric; Lamp, Infrared, Therapeutic Heating; Pad, Heating, Powered; U.V. Light, Tlc |
| Osstem Implant Co.,Ltd. | Manufacturer | 11 | Chair, Dental, With Operative Unit; Unit, Operative Dental; Unit, X-Ray, Intraoral; Chair, Dental, Without Operative Unit; X-Ray, Tomography, Computed, Dental; Unit, X-Ray, Extraoral With Timer |
| Chengdu Cryo-Push Medical Technology Co.,Ltd | Manufacturer | 4 | Pack, Hot Or Cold, Reusable; Massager, Powered Inflatable Tube; Pack, Hot Or Cold, Water Circulating |
| Jm Medical Co., Ltd. | Manufacturer | 8 | Bandage, Cast; Bag, Urine Collection, Leg, For External Use, Sterile; Collector, Urine, (And Accessories) For Indwelling Catheter; Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use; Bag, Drainage, With Adhesive, Ostomy; Dressing, Wound, Hydrogel Without Drug And/Or Biologic; Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile; Non-Surgical Gown |
| Laparomed Private Limited | Manufacturer | 51 | Probe, Periodontic; Spatula, Surgical, General & Plastic Surgery; Mirror, Mouth; Retractor; Handle, Scalpel; Retractor, Ophthalmic; Control, Platelet; Holder, Needle; Orthopedic; Gag, Mouth; Forceps, Ophthalmic |
| Vitaltec Corporation | Manufacturer | 1 | Tube, Tracheostomy (W/Wo Connector) |
| Micro-Tech (Nanjing) Co., Ltd. | Manufacturer | 2 | Endoscopic Injection Needle, Gastroenterology-Urology; Ultrasound Bronchoscope |
| Micro-Tech (Nanjing) Co., Ltd. | Manufacturer | 2 | Endoscopic Injection Needle, Gastroenterology-Urology; Ultrasound Bronchoscope |
| Foshan Soco Precision Instrument Co.,Ltd. | Manufacturer | 3 | Loupe, Diagnostic/Surgical; Light, Surgical Headlight; Mirror, Mouth |
| AMD Medicom Inc. | Manufacturer | 9 | Polymer Patient Examination Glove; Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs; Medical Glove, Specialty; Powder-Free Polychloroprene Patient Examination Glove; Fentanyl And Other Opioid Protection Glove |
| K-Med Co., Ltd. | Manufacturer | 1 | Tube, Aspirating, Flexible, Connecting |
| Fussen Technology Co., Ltd | Manufacturer | 1 | X-Ray, Tomography, Computed, Dental |
| Alliedstar Medical Equipment Co., Ltd. | Manufacturer | 1 | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Anrei Medical (Hangzhou) Co., Ltd. | Manufacturer | 1 | Hemostatic Metal Clip For The Gi Tract |
| Anhui Jbh Medical Apparatus Co., Ltd | Manufacturer | 1 | Wheelchair, Powered |
| Wellysis Corp. | Manufacturer | 1 | Electrocardiograph |
| Shenzhen Xiazhifeng Electronic Co., Ltd | Manufacturer | 1 | Light Based Over-The-Counter Hair Removal |
| Stryker Ireland Ltd. Instruments Division, Innovation Centre | Specification developer (outsources manufacturing) | 2 | Electrosurgical, Cutting & Coagulation & Accessories; Instrument, Ultrasonic Surgical |
| Ge Healthcare (Tianjin) Company Limited | Manufacturer | 1 | System, Nuclear Magnetic Resonance Imaging |
| Miracell Co.,Ltd. | Manufacturer | 3 | Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate; Accessories, Arthroscopic; Stand, Infusion |
| Jochu Technology Co., Ltd | Manufacturer | 1 | Vehicle, Motorized 3-Wheeled |
| Respironics, Inc. | Manufacturer | 1 | Ventilator, Non-Continuous (Respirator) |
| Suretex, Ltd. | Manufacturer | 1 | Condom |
| Beijing Beautemax Technology Limited | Manufacturer | 1 | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Jiangsu Intco Medical Products Co., Ltd. | Manufacturer | 1 | Vehicle, Motorized 3-Wheeled |
| Ezisurg Medical Co., Ltd. | Manufacturer | 2 | Staple, Implantable; Stapler, Surgical |
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