DeviceEstablishmentPulse: Manufacturer, 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 |
|---|---|---|---|
| Tutamen De Mexico, LLC | Manufacturer | 4 | Laser, Comb, Hair; Sleeve, Limb, Compressible; Immunoglobulin G (Igg) Infusion System |
| Samsung Medison Co., Ltd. | Manufacturer | 13 | Transducer, Ultrasonic, Diagnostic; System, Image Processing, Radiological; System, Imaging, Pulsed Doppler, Ultrasonic; Automated Radiological Image Processing Software; System, Imaging, Pulsed Echo, Ultrasonic |
| Samsung Medison Co., Ltd. | Manufacturer | 13 | Transducer, Ultrasonic, Diagnostic; System, Image Processing, Radiological; System, Imaging, Pulsed Doppler, Ultrasonic; Automated Radiological Image Processing Software; System, Imaging, Pulsed Echo, Ultrasonic |
| AIRS Medical Inc. | Manufacturer | 4 | Automated Radiological Image Processing Software; System, Nuclear Magnetic Resonance Imaging; System, Digital Image Communications, Radiological |
| Stryker Leibinger GmbH & Co. Kg | Manufacturer | 5 | Plate, Bone; Drill, Bone, Powered; Driver, Wire, And Bone Drill, Manual; Plate, Fixation, Bone; Screw, Fixation, Bone |
| Ningbo Landing Technology Company Co., Ltd. | Manufacturer | 3 | Massager, Therapeutic, Electric; Joint, Knee, External Brace; Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter |
| GE Healthcare Japan Corporation | Manufacturer | 19 | System, Imaging, Pulsed Doppler, Ultrasonic; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Echo, Ultrasonic; Automated Radiological Image Processing Software; Twister, Brace Setting |
| Wipro Ge Medical Device Manufacturing Private Limited | Manufacturer | 19 | Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; Automated Radiological Image Processing Software; Twister, Brace Setting; System, Imaging, Pulsed Echo, Ultrasonic |
| Wipro GE Healthcare Private Ltd. | Manufacturer | 19 | Automated Radiological Image Processing Software; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; Twister, Brace Setting |
| Ge Medical Systems (China) Co., Ltd. | Manufacturer | 45 | Automated Radiological Image Processing Software; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; Twister, Brace Setting; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.); Detector And Alarm, Arrhythmia; Oximeter, Ear; Monitor, St Segment With Alarm |
| GE Healthcare Austria GmbH & Co OG | Manufacturer | 21 | Automated Radiological Image Processing Software; System, Image Processing, Radiological; System, Imaging, Pulsed Doppler, Ultrasonic; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Echo, Ultrasonic; Twister, Brace Setting |
| Lords Mark Industries Ltd. | Manufacturer | 50 | Radioimmunoassay, Total Triiodothyronine; Enzymatic Esterase--Oxidase, Cholesterol; Ferrozine (Colorimetric) Iron Binding Capacity; Antigens, All, Leptospira Spp.; Orthosis, Foot Drop; Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine; Belt, Pelvic, Traction; Acid, Uric, Uricase (Colorimetric); Kit, Direct Antigen, Positive Control; Shield, Protective, Personnel |
| Poly Medicure Ltd. | Manufacturer | 3 | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days |
| Warrenslove(Hongkong)limited | Manufacturer | 4 | Massager, Powered Inflatable Tube; Laser, Comb, Hair; Lamp, Infrared, Therapeutic Heating |
| Medcave Private Limited | Manufacturer | 100 | File, Margin Finishing, Operative; Knife, Periodontic; Explorer, Operative; Syringe, Cartridge; Pusher, Band, Orthodontic; Spatula, Orthopedic; Chisel, Osteotome, Surgical; Accessories, Retractor, Dental; Holder, Needle; Orthopedic; Remover, Crown |
| Lakong Medical Devices Co., Ltd. | Manufacturer | 4 | Chair, Dental, With Operative Unit; Unit, Operative Dental; Scanner, Color; Portable Dental Operative Unit |
| Shenzhen Hugemed Medical Technical Development Co., Ltd | Manufacturer | 4 | Stand, Infusion; Dislodger, Stone, Basket, Ureteral, Metal; Pump, Portable, Aspiration (Manual Or Powered); Endoscopic Guidewire, Gastroenterology-Urology |
| Guilin Kevin Peter Technology Co., Ltd. | Manufacturer | 7 | Material, Tooth Shade, Resin; Sealant, Pit And Fissure, And Conditioner; Powered Laser Surgical Instrument; Light, Examination, Medical, Battery Powered; Resin, Root Canal Filling; Liner, Cavity, Calcium Hydroxide |
| FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa | Manufacturer | 3 | System, X-Ray, Tomography, Computed; System, Nuclear Magnetic Resonance Imaging |
| Zhengzhou Youtai Health Technology Co., Ltd. | Manufacturer | 3 | Light Based Over The Counter Wrinkle Reduction; Over-The-Counter Powered Light Based Laser For Acne; Lamp, Infrared, Therapeutic Heating |
| Zhengzhou Zhongkemei Health 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 |
| FUJIFILM Healthcare Manufacturing Corporation Kashiwa Office | Manufacturer | 3 | System, Nuclear Magnetic Resonance Imaging; System, X-Ray, Tomography, Computed |
| Boston Scientific Corporation | Manufacturer | 6 | Kit, Nephroscope; Cystoscope And Accessories, Flexible/Rigid; Endoscopic Access Overtube, Gastroenterology-Urology; Ureteroscope And Accessories, Flexible/Rigid; Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Endoscopic Ultrasound System, Gastroenterology-Urology |
| St. Jude Medical, Atrial Fibrillation Division, Inc. | Manufacturer | 3 | Computer, Diagnostic, Programmable |
| Sound Technology Inc. | Manufacturer | 4 | Automated Radiological Image Processing Software; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic |
| St. Jude Medical, Cardiology Division, Inc. | Manufacturer | 4 | Computer, Diagnostic, Programmable; System, Appendage Closure, Left Atrial |
| Intuitive Surgical, Inc. | Manufacturer | 9 | System, Surgical, Computer Controlled Instrument; System, X-Ray, Angiographic; Laparoscope, General & Plastic Surgery; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Gastroscope And Accessories, Flexible/Rigid; Insufflator, Laparoscopic |
| Intuitive Surgical, Inc. | Manufacturer | 9 | System, Surgical, Computer Controlled Instrument; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Gastroscope And Accessories, Flexible/Rigid; System, X-Ray, Angiographic; Laparoscope, General & Plastic Surgery; Insufflator, Laparoscopic |
| Neptune Medical, Inc | Manufacturer | 3 | Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Colonoscope And Accessories, Flexible/Rigid; Endoscopic Access Overtube, Gastroenterology-Urology |
| Leica Biosystems Imaging, Inc. | Manufacturer | 3 | Whole Slide Imaging System; Digital Pathology Image Artifact Detection Software Device; Digital Pathology Image Viewing And Management Software |
| Smith & Nephew Inc. | Manufacturer | 3 | Intra-Articular Orthopedic Stereotaxic Navigation Instrument; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
| Siemens Medical Solutions USA, Inc. | Manufacturer | 7 | Automated Radiological Image Processing Software; Biopsy Needle Guide Kit; Catheter, Ultrasound, Intravascular; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; Transducer, Ultrasonic, Diagnostic |
| Lightning X Products, Inc | Manufacturer | 32 | Blood Pressure Cuff; Oximeter; Stethoscope, Manual; Polymer Patient Examination Glove; System, Measurement, Blood-Pressure, Non-Invasive; Ventilator, Emergency, Manual (Resuscitator); Splint, Hand, And Components; Cannula, Nasal, Oxygen; Gauze / Sponge,Nonresorbable For External Use; Sling, Arm |
| Draeger Medical Systems, Inc. | Manufacturer | 17 | Continuous Measurement Thermometer; Computer, Blood-Pressure; System, Measurement, Blood-Pressure, Non-Invasive; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms); Cable, Transducer And Electrode, Patient, (Including Connector); Recorder, Paper Chart; System, Network And Communication, Physiological Monitors; Monitor, Breathing Frequency; Plethysmograph, Impedance; Computer, Diagnostic, Pre-Programmed, Single-Function |
| Roche Molecular Systems, Inc. | Manufacturer | 4 | Dna-Reagents, Neisseria; Dna Probe, Nucleic Acid Amplification, Chlamydia; Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections; Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System |
| Radformation, Inc. | Manufacturer | 3 | System, Planning, Radiation Therapy Treatment; Accelerator, Linear, Medical; Radiological Image Processing Software For Radiation Therapy |
| Fiagon Na LLC | Manufacturer | 3 | Eustachian Tube Balloon Dilation Device; Instrument, Ent Manual Surgical; Balloon, Nasal Airway |
| Cleerly, Inc | Manufacturer | 3 | System, Image Processing, Radiological; Automated Radiological Image Processing Software |
| Centerpoint Systems LLC | Manufacturer | 4 | Introducer, Catheter; Catheter, Percutaneous |
| Zeus Scientific LLC | Manufacturer | 7 | Extractable Antinuclear Antibody, Antigen And Control; Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm); Test System, Antineutrophil Cytoplasmic Antibodies (Anca); Anti-Ss-A Ro60 Autoantibodies; Anti-Ss-A 52 Autoantibodies |
| Spine Wave, Inc. | Manufacturer | 6 | Intervertebral Fusion Device With Bone Graft, Lumbar; Bit, Drill; Gauge, Depth; Guide, Surgical, Instrument; Bone Cement, Posterior Screw Augmentation; Thoracolumbosacral Pedicle Screw System |
| Hsg-S Corp | Manufacturer | 20 | Cleanser, Root Canal; Plugger, Root Canal, Endodontic; Instrument, Diamond, Dental; Scaler, Ultrasonic; Explorer, Operative; Tester, Pulp; Carrier, Amalgam, Operative; Resin, Root Canal Filling; Syringe, Periodontic, Endodontic, Irrigating; Gauge, Depth, Instrument, Dental |
| Siemens Healthcare Diagnostics Inc. | Manufacturer | 5 | System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer; Single (Specified) Analyte Controls (Assayed And Unassayed); Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125); System, Test, Carcinoembryonic Antigen; Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions |
| Auris Health, Inc | Manufacturer | 3 | Integrated Operating Table-Electromechanical Surgical System; System, X-Ray, Tomography, Computed; Bronchoscope (Flexible Or Rigid) |
| Ultradent Products Inc. | Manufacturer | 3 | Material, Tooth Shade, Resin; Adhesive, Bracket And Tooth Conditioner, Resin; Varnish, Cavity |
| Coopersurgical, Inc. | Manufacturer | 10 | Fetal Head Elevator; Retractor; Media, Reproductive; Accessory, Assisted Reproduction; Catheter And Tip, Suction; Speculum, Vaginal, Nonmetal; Anoscope And Accessories; Pessary, Vaginal |
| Alta Smiles, LLC | Manufacturer | 13 | Accessories, Retractor, Dental; Band, Elastic, Orthodontic; Instrument, Diamond, Dental; Instrument, Cutting, Operative; Spring, Orthodontic; Plier, Orthodontic; Bracket, Metal, Orthodontic; Instrument, Filling, Plastic, Dental; Aligner, Sequential; Instruments, Dental Hand |
| Siemens Healthcare Diagnostics Inc. | Manufacturer | 3 | Bilirubin (Total And Unbound) In The Neonate Test System; Diazo Colorimetry, Bilirubin; Colorimetry, Acetaminophen |
| HR PHARMACEUTICALS, INC d/b/a HR HealthCare | Manufacturer | 4 | Collector, Urine, Powered, Non Indwelling Catheter; Drape, Surgical, Exempt; Table, Cystometric, Electric; Catheter, Straight |
| Pascall Systems Inc | Manufacturer | 4 | Non-Normalizing Quantitative Electroencephalograph Software; Reduced- Montage Standard Electroencephalograph; Electrode, Cutaneous; Burst Suppression Detection Software For Electroencephalograph |
| Merit Medical Systems, Inc. | Manufacturer | 7 | Catheter, Embolectomy; Dilator, Vessel, For Percutaneous Catheterization; Endoscopic Access Overtube, Gastroenterology-Urology; Endoscopic Irrigation/Suction System; Unit, Cryosurgical, Accessories |
| Hill-Rom, Inc. | Manufacturer | 3 | Monitor, Breathing Frequency; System, Network And Communication, Physiological Monitors; Bed, Ac-Powered Adjustable Hospital |
| OrthAlign, Inc. | Manufacturer | 3 | Intraoperative Orthopedic Joint Assessment Aid; Orthopedic Stereotaxic Instrument |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Manufacturer | 6 | Radioimmunoassay, Estrone; Reagents, Cysticercosis; Enzyme Linked Immunoabsorbent Assay, Mumps Virus; Blood, Occult, Colorimetric, In Urine; Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users; Devices Detecting Influenza A, B, And C Virus Antigens |
| Trimed, Inc. | Manufacturer | 4 | Screw, Fixation, Bone; Plate, Fixation, Bone |
| Howmedica Osteonics Corp | Manufacturer | 11 | Cement Obturator; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Prosthesis, Hip, Hemi-, Femoral, Metal; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| S. Jackson, Inc. | Manufacturer | 4 | Suture, Nonabsorbable, Synthetic, Polyamide |
| Dexcom, Inc. | Manufacturer | 5 | Tape And Bandage, Adhesive; Integrated Continuous Glucose Monitoring System, Factory Calibrated; Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter; Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter |
| Dexcom, Inc. | Manufacturer | 3 | Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter; Tape And Bandage, Adhesive; Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter |
| Depuy Orthopaedics, Inc. | Manufacturer | 12 | Bone Cement; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Hemi-, Femoral, Metal; Bone Cement, Antibiotic; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
| Nihon Kohden America, Inc. | Manufacturer | 5 | Tape And Bandage, Adhesive; Standard Polysomnograph With Electroencephalograph; Stimulator, Photic, Evoked Response; Full-Montage Standard Electroencephalograph; Non-Normalizing Quantitative Electroencephalograph Software |
| Globus Medical, Inc. | Manufacturer | 16 | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Thoracolumbosacral Pedicle Screw System; Growing Rod System; Appliance, Fixation, Spinal Interlaminal; Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
| Globus Medical, Inc. | Manufacturer | 12 | Rod, Fixation, Intramedullary And Accessories; Screw, Fixation, Bone; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented |
| Acist Medical Systems, Inc. | Manufacturer | 3 | Injector And Syringe, Angiographic; Injector, Contrast Medium, Automatic |
| BioticsAI, Inc. | Manufacturer | 3 | Automated Radiological Image Processing Software; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic |
| Tandem Diabetes Care, Inc. | Manufacturer | 3 | Interoperable Automated Glycemic Controller; Alternate Controller Enabled Insulin Infusion Pump |
| Huneo, LLC | Manufacturer | 3 | Standard Polysomnograph With Electroencephalograph; Automatic Event Detection Software For Polysomnograph With Electroencephalograph; Ventilatory Effort Recorder |
| Alphatec Spine, Inc. | Manufacturer | 10 | Thoracolumbosacral Pedicle Screw System; Orthopedic Stereotaxic Instrument; Appliance, Fixation, Spinal Intervertebral Body; Sacroiliac Joint Fixation; Bone Cement, Posterior Screw Augmentation; Appliance, Fixation, Spinal Interlaminal; System, Image Processing, Radiological; Interventional Fluoroscopic X-Ray System; Automated Intraoperative Spinal Rod Bending System; System, X-Ray, Fluoroscopic, Image-Intensified |
| Alphatec Spine, Inc. | Manufacturer | 10 | Thoracolumbosacral Pedicle Screw System; Orthopedic Stereotaxic Instrument; Appliance, Fixation, Spinal Intervertebral Body; Sacroiliac Joint Fixation; Bone Cement, Posterior Screw Augmentation; Appliance, Fixation, Spinal Interlaminal; System, Image Processing, Radiological; Interventional Fluoroscopic X-Ray System; Automated Intraoperative Spinal Rod Bending System; System, X-Ray, Fluoroscopic, Image-Intensified |
| O&M Halyard, Inc. | Manufacturer | 11 | Anti Fog Solution And Accessories, Endoscopy; Restraint, Protective; Wrap, Sterilization; Fentanyl And Other Opioid Protection Glove; Medical Glove, Specialty; Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs; Polymer Patient Examination Glove; Orthosis, Limb Brace; Dressing, Wound, Drug; Clinical Electronic Thermometer |
| Spinal Elements, Inc. | Manufacturer | 3 | Intervertebral Fusion Device With Bone Graft, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| restor3d, inc. | Manufacturer | 4 | Shoulder Prosthesis, Reverse Configuration; Shoulder Arthroplasty Implantation System; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Angiodynamics, Inc. | Manufacturer | 3 | System, Ablation, Microwave And Accessories |
| Angiodynamics, Inc | Manufacturer | 3 | System, Ablation, Microwave And Accessories |
| MedSource Labs, LLC | Manufacturer | 4 | General Purpose Dental Tray; Clinical Electronic Thermometer; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days |
| Fujifilm Sonosite,Inc. | Manufacturer | 3 | System, Imaging, Pulsed Doppler, Ultrasonic; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Echo, Ultrasonic |
| Topcon Healthcare, Inc. | Manufacturer | 9 | Refractometer, Ophthalmic; Tonometer, Ac-Powered; Microscope, Operating & Accessories, Ac-Powered, Ophthalmic; Microscope, Specular; Tomography, Optical Coherence; Refractor, Manual, Non-Powered, Including Phoropter; Biomicroscope, Slit-Lamp, Ac-Powered; Camera, Ophthalmic, Ac-Powered; Chart, Visual Acuity |
| Materialise USA, LLC. | Manufacturer | 3 | Shoulder Arthroplasty Implantation System; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Alcon Research, LLC | Manufacturer | 3 | Extended Depth Of Focus Intraocular Lens; Lens, Intraocular, Toric Optics; Lens, Multifocal Intraocular |
| Alcon Research, LLC | Manufacturer | 3 | Lens, Multifocal Intraocular; Extended Depth Of Focus Intraocular Lens; Lens, Intraocular, Toric Optics |
| Venus Concept Inc. | Manufacturer | 7 | Electrosurgical, Cutting & Coagulation & Accessories; Powered Laser Surgical Instrument; Massager, Vacuum, Radio Frequency Induced Heat; Powered Light Based Non-Laser Surgical Instrument With Thermal Effect |
| Venus Concept Inc. | Manufacturer | 7 | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect; Electrosurgical, Cutting & Coagulation & Accessories; Powered Laser Surgical Instrument; Massager, Vacuum, Radio Frequency Induced Heat |
| Victorch Meditek, Inc. | Manufacturer | 15 | Antisera, Fluorescent, Chlamydia Spp.; Single (Specified) Analyte Controls (Assayed And Unassayed); Campylobacter Spp.; Scissors, Medical, Disposable; Control, Fecal Occult Blood; Applicator, Absorbent Tipped, Sterile; Antigen(Complexed),Prostate Specific,(Cpsa); Device, Neurovascular Embolization; Wrap, Sterilization; Transferrin, Antigen, Antiserum, Control |
| Exactech, Inc. | Manufacturer | 5 | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate |
| Inter-Med, Inc. | Manufacturer | 3 | Cement, Dental; Agent, Tooth Bonding, Resin; Cord, Retraction |
| Inova Diagnostics, Inc. | Manufacturer | 3 | System, Test, Anticardiolipin Immunological; System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi); System, Multipurpose For In Vitro Coagulation Studies |
| Zyris, Inc. | Manufacturer | 3 | Drape, Surgical, Exempt; Dental Barriers And Sleeves; Evacuator, Oral Cavity |
| Spectrawave, Inc. | Manufacturer | 17 | System, Imaging, Optical Coherence Tomography (Oct); Optical Coherence Tomography, Intravascular Catheter; Catheter, Intravascular, Plaque Morphology Evaluation; System, Imaging, Pulsed Echo, Ultrasonic; System, Image Processing, Radiological; X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device |
| Autonomous Medical Devices Incorporated | Manufacturer | 5 | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays; Respiratory Virus Panel Nucleic Acid Assay System; Real Time Nucleic Acid Amplification System; Influenza A And Influenza B Multiplex Nucleic Acid Assay; Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents |
| Pathwai, Inc | Manufacturer | 6 | Pulmonary Hypertension Machine Learning-Based Notification Software; Valvular Regurgitation Machine Learning-Based Notification Software; Reduced Ejection Fraction Machine Learning-Based Notification Software; Cardiovascular Machine Learning-Based Notification Software; Cardiac Hypertrophy Machine Learning-Based Notification Software; Aortic Stenosis Machine Learning-Based Notification Software |
| Access Vascular, Inc | Manufacturer | 3 | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days |
| Medline Industries, LP - Spt | Manufacturer | 7 | Electrosurgical, Cutting & Coagulation & Accessories; General Surgery Tray |
| E. Benson Hood Laboratories, Inc. | Manufacturer | 13 | Prosthesis, Larynx (Stents And Keels); Button, Nasal Septal; Catheters, Suction, Tracheobronchial; Prosthesis, Tracheal, Preformed/Molded; Device, Fixation, Tracheal Tube; Tube, Tracheostomy (W/Wo Connector); Splint, Nasal; Tube, Laryngectomy; Bronchoscope (Flexible Or Rigid); Cannula, Sinus |
| Dunamis Medical LLC | Manufacturer | 3 | Suture, Nonabsorbable, Synthetic, Polyethylene; Fastener, Fixation, Nondegradable, Soft Tissue; Screw, Fixation, Bone |
| CQ Decimal, LLC | Manufacturer | 14 | Block, Beam-Shaping, Radiation Therapy; System, Planning, Radiation Therapy Treatment; Accelerator, Linear, Medical |
| Ischemaview, Inc. | Manufacturer | 4 | System, Image Processing, Radiological; Automated Radiological Image Processing Software; Radiological Computer-Assisted Triage And Notification Software |
| Drive Northpoint, LLC | Manufacturer | 26 | Pack, Hot Or Cold, Reusable; Device, Biofeedback; Interferential Current Therapy; Stimulator, Neuromuscular, External Functional; Stimulator, Nerve, Transcutaneous, For Pain Relief; Stimulator, Muscle, Powered; Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat; Stimulator, Muscle, Powered, For Muscle Conditioning; Stimulator, Nerve, Transcutaneous, Over-The-Counter; Joint, Ankle, External Brace |
| Hc Biologics LLC | Manufacturer | 3 | Intervertebral Fusion Device With Integrated Fixation, Cervical; Intervertebral Fusion Device With Bone Graft, Cervical; Intervertebral Fusion Device With Bone Graft, Lumbar |
| The Binding Site, Inc. | Manufacturer | 6 | Lambda, Antigen, Antiserum, Control; Kappa, Antigen, Antiserum, Control |
| Spinecraft LLC | Manufacturer | 4 | Appliance, Fixation, Spinal Intervertebral Body; Intervertebral Fusion Device With Bone Graft, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Bone Graft, Cervical |
| Medinova Group Co. | Manufacturer | 21 | Forceps; Pack, Hot Or Cold, Disposable; Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear); Pad, Eye; Tape And Bandage, Adhesive; Container, Specimen Mailer And Storage, Non-Sterile; Disinfectant, Medical Devices; Accessory, Surgical Apparel; Enzyme Immunoassay, Opiates; Punch, Gelfoam, Non-Sterile |
| Imex, LLC | Manufacturer | 10 | Electrode, Cutaneous; Pack, Hot Or Cold, Water Circulating; Lamp, Infrared, Therapeutic Heating; Stimulator, Nerve, Transcutaneous, For Pain Relief; Interferential Current Therapy; Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat; Stimulator, Muscle, Powered; Pack, Hot Or Cold, Reusable |
| Medtronic Puerto Rico Operations Co., Humacao | Manufacturer | 3 | Appliance, Fixation, Spinal Interlaminal; Thoracolumbosacral Pedicle Screw System; Appliance, Fixation, Spinal Intervertebral Body |
| Iradimed Corporation | Manufacturer | 3 | Set, I.V. Fluid Transfer; Stand, Infusion; Pump, Infusion |
| Valencia Technologies Corporation | Manufacturer | 4 | Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence; Instrument, Surgical, Non-Powered; General Surgery Tray; Dressing Change Tray |
| Case Medical, Inc. | Manufacturer | 1 | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Beta Bionics, Inc. | Manufacturer | 2 | Continuous Glucose Monitor Retrospective Data Analysis Software; Alternate Controller Enabled Insulin Infusion Pump |
| NAR Medical Depot, LLC | Manufacturer | 2 | Airway Suction Kit; Pelvic Exam Kit |
| Nusmile, Ltd | Manufacturer | 2 | Resin, Root Canal Filling; Liner, Cavity, Calcium Hydroxide |
| MicroVention, Inc. | Manufacturer | 2 | Aspiration Thrombectomy Catheter; Catheter, Continuous Flush |
| CorDx, Inc. | Manufacturer | 2 | Multi-Analyte Respiratory Virus Antigen Detection Test; Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings |
| Penumbra, Inc. | Manufacturer | 2 | Peripheral Mechanical Thrombectomy With Aspiration; Catheter, Thrombus Retriever |
| Penumbra Inc. | Manufacturer | 2 | Peripheral Mechanical Thrombectomy With Aspiration; Catheter, Thrombus Retriever |
| Penumbra Inc. | Manufacturer | 2 | Catheter, Thrombus Retriever; Peripheral Mechanical Thrombectomy With Aspiration |
| Personal Genome Diagnostics Inc. | Manufacturer | 1 | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| Subtle Medical Inc | Manufacturer | 2 | Automated Radiological Image Processing Software; System, Image Processing, Radiological |
| Penumbra Inc. | Manufacturer | 2 | Catheter, Thrombus Retriever; Peripheral Mechanical Thrombectomy With Aspiration |
| Epic Systems Corporation | Manufacturer | 1 | Medium-Term Adjunctive Predictive Cardiovascular Indicator |
| Medivators Inc | Manufacturer | 1 | Accessories, Cleaning, For Endoscope |
| Steris Corporation | Manufacturer | 2 | Accessories, Cleaning, For Endoscope; Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe |
| CapsoVision, Inc. | Manufacturer | 1 | Gastrointestinal Capsule Endoscopy Analysis Software Device |
| Prodeon Medical, Inc. | Manufacturer | 1 | Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia |
| Medtronic Xomed, Inc. | Manufacturer | 1 | Ear, Nose, And Throat Stereotaxic Instrument |
| Inkspace Imaging, Inc | Manufacturer | 1 | Coil, Magnetic Resonance, Specialty |
| Circuit Works Corporation | Manufacturer | 1 | Audiometer |
| Anumana Inc. | Manufacturer | 2 | Pulmonary Hypertension Machine Learning-Based Notification Software; Cardiac Amyloidosis Machine Learning-Based Notification Software |
| Tela Bio, Inc. | Manufacturer | 2 | Mesh, Surgical, Polymeric; Mesh, Surgical |
| Church & Dwight Manufacturing Co., Inc. | Manufacturer | 1 | Condom |
| GE Healthcare Manufacturing LLC | Manufacturer | 1 | System, Nuclear Magnetic Resonance Imaging |
| GE Healthcare Manufacturing LLC | Manufacturer | 1 | System, Nuclear Magnetic Resonance Imaging |
| Providence Medical Technology, Inc. | Manufacturer | 2 | System, Facet Screw Spinal Device; Orthopedic Stereotaxic Instrument |
| Maxter Healthcare Inc | Manufacturer | 4 | Fentanyl And Other Opioid Protection Glove; Medical Glove, Specialty; Polymer Patient Examination Glove; Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs |
| Anika Therapeutics, Inc. | Manufacturer | 2 | Absorbable Synthetic Wound Dressing; Fastener, Fixation, Nondegradable, Soft Tissue |
| Cerenovus, Inc. | Manufacturer | 1 | Neurovascular Liquid Embolic Agent |
| Tornier, Inc. | Manufacturer | 1 | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Apryse Software Corp. | Manufacturer | 1 | System, Image Processing, Radiological |
| Life Technologies Corporation | Manufacturer | 1 | Assay, Genotype, Hiv Drug Resistance, In Vitro |
| Rejoni, Inc | Manufacturer | 1 | Barrier, Absorbable, Adhesion |
| Si-Bone, Inc. | Manufacturer | 2 | Thoracolumbosacral Pedicle Screw System; Orthopedic Stereotaxic Instrument |
| Cutera, Inc. | Manufacturer | 2 | Powered Laser Surgical Instrument; Electrosurgical, Cutting & Coagulation & Accessories |
| Carlsmed, Inc. | Manufacturer | 2 | Appliance, Fixation, Spinal Intervertebral Body |
| Mastel Surgical Inc. | Manufacturer | 1 | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Medshape, Inc. | Manufacturer | 2 | Washer, Bolt Nut; Screw, Fixation, Bone |
| Kci USA, Inc. | Manufacturer | 1 | Negative Pressure Wound Therapy Powered Suction Pump |
| Wandercraft Incorporated | Manufacturer | 1 | Powered Exoskeleton |
| Mozarc Medical Us LLC | Manufacturer | 1 | Needle, Fistula |
| Supera Fulfillment LLC | Manufacturer | 1 | Blood Specimen Collection Convenience Kit (Excludes Hiv) |
| Gt Metabolic Solutions, Inc. | Manufacturer | 2 | Magnetic Compression Anastomosis System; Retractor |
| NuVasive Specialized Orthopedics, Inc. | Manufacturer | 2 | Rod, Fixation, Intramedullary And Accessories; Screw, Fixation, Bone |
| Surefire Medical, Inc. | Manufacturer | 1 | Catheter, Continuous Flush |
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