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# DeviceEstablishmentPulse: Manufacturer, page 4 of 4

Records 351 to 500 of the 500 newest listed for this hub. Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration).

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| Record | Role | New listings | Devices |
|---|---|---|---|
| Innovacyn, Inc. | Manufacturer | 2 | Dressing, Wound, Drug; Lavage, Jet |
| Bio Compression Systems, Inc. | Manufacturer | 1 | Sleeve, Limb, Compressible |
| Baebies Inc. | Manufacturer | 1 | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents |
| Smith & Nephew, Inc. | Manufacturer | 2 | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
| Parkell, Inc. | Manufacturer | 1 | Sealant, Pit And Fissure, And Conditioner |
| Smith & Nephew, Inc. | Manufacturer | 2 | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
| Linvatec Corporation | Manufacturer | 1 | Fastener, Fixation, Nondegradable, Soft Tissue |
| Eminent Spine, LLC | Manufacturer | 2 | Thoracolumbosacral Pedicle Screw System; Sacroiliac Joint Fixation |
| Bechtel Medical Inc | Manufacturer | 2 | Dressing, Wound, Occlusive; Negative Pressure Wound Therapy Powered Suction Pump |
| Mastercraft Dental Co. Of Texas | Manufacturer | 4 | Chair, With Casters; Light, Operating, Dental; Unit, Operative Dental, Accessories; Chair, Dental, Without Operative Unit |
| Aura Wellness, LLC | Manufacturer | 2 | Electromagnetic Stimulator For Healthy Muscle Stimulation; Stimulator, Muscle, Powered, For Muscle Conditioning |
| Ark Diagnostics Inc | Manufacturer | 2 | Anti-Factor Xa Activity Test System, Apixaban; Enzyme Immunoassay, Benzodiazepine |
| Prismatik Dentalcraft, Inc. | Manufacturer | 2 | Resin, Denture, Relining, Repairing, Rebasing; Powder, Porcelain |
| Emboline Inc | Manufacturer | 1 | Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures |
| Shockwave Medical, Inc. | Manufacturer | 1 | Percutaneous Catheter, Ultrasound |
| Abmrc LLC | Manufacturer | 1 | Device, Positive Pressure Breathing, Intermittent |
| Bolt Medical Inc. | Manufacturer | 1 | Percutaneous Catheter, Ultrasound |
| Somnetics International, Inc | Manufacturer | 1 | Ventilator, Non-Continuous (Respirator) |
| Cogentix Medical, Inc. | Manufacturer | 2 | Cystoscope And Accessories, Flexible/Rigid; Hysteroscope (And Accessories) |
| Glytec, LLC | Manufacturer | 1 | Calculator, Drug Dose |
| TEMPUS AI, Inc. | Manufacturer | 2 | Pulmonary Hypertension Machine Learning-Based Notification Software; Next Generation Sequencing Based Tumor Profiling Test |
| VivaQuant, Inc | Manufacturer | 1 | Ventilatory Effort Recorder |
| Konica Minolta Healthcare Americas, Inc | Manufacturer | 2 | Solid State X-Ray Imager (Flat Panel/Digital Imager); System, Image Processing, Radiological |
| Sequitur Health Corp. | Manufacturer | 3 | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use; Photometric Method, Ammonia; Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Imperative Care Inc. | Manufacturer | 1 | Catheter, Percutaneous, Neurovasculature |
| Signature Science, LLC | Manufacturer | 1 | Forensic Evidence Sexual Assault Kit |
| Reflow Medical, Inc | Manufacturer | 1 | Catheter For Crossing Total Occlusions |
| Auris Health, Inc. | Manufacturer | 2 | System, X-Ray, Tomography, Computed; Bronchoscope (Flexible Or Rigid) |
| AbbVie Inc. | Manufacturer | 1 | On-Body Injector |
| SW Technologies Inc. | Manufacturer | 4 | Polymer Patient Examination Glove; Fentanyl And Other Opioid Protection Glove; Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs; Medical Glove, Specialty |
| Apyx Medical Corporation | Manufacturer | 2 | System, Suction, Lipoplasty For Removal |
| Synova Life Sciences, Inc. | Manufacturer | 1 | Lipoaspirate Washing System For Aesthetic Body Contouring |
| Daxor Corporation | Manufacturer | 2 | Container, Specimen, Non-Sterile; Device, Blood Volume Measuring |
| Gravitas Medical, Inc. | Manufacturer | 2 | Tubes, Gastrointestinal (And Accessories); Tube, Feeding |
| Neko Health Manufacturing LLC | Manufacturer | 1 | Stethoscope, Electronic |
| Alcon Research, LLC | Manufacturer | 2 | Laser, Ophthalmic; Drape, Surgical, Exempt |
| One Lambda, Inc. | Manufacturer | 1 | Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test |
| Pac-Dent Inc. | Manufacturer | 2 | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations; Cement, Dental |
| Prime Dental Manufacturing, Inc. | Manufacturer | 2 | Applicator, Resin; Unit, X-Ray, Intraoral |
| Medgyn Products, Inc. | Manufacturer | 2 | Electrocautery, Gynecologic (And Accessories); Catheter, Nasopharyngeal |
| BioLife Plasma Services L.P. | Manufacturer | 1 | Blood Establishment Computer Software And Accessories |
| CorDx, Inc. | Manufacturer | 1 | Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings |
| NEUROCAREAI INC (DBA SaveLife.AI) | Manufacturer | 1 | Radiological Computer-Assisted Prioritization Software For Lesions |
| Cryosurgery, Inc. | Manufacturer | 1 | Unit, Cryosurgical, Accessories |
| Zevex, Inc. | Manufacturer | 2 | Pump, Infusion; Set, Administration, Intravascular |
| Trividia Health, Inc. | Manufacturer | 1 | System, Test, Blood Glucose, Over The Counter |
| Nobel Biocare USA, LLC | Manufacturer | 2 | Dental Abutment Design Software For Dental Laboratory; Abutment, Implant, Dental, Endosseous |
| O&S Dental, Inc. | Manufacturer | 1 | Unit, X-Ray, Intraoral |
| Fainteer Limited | Manufacturer | 1 | Pulse Oximeter For Over-The-Counter Use |
| Spr Therapeutics, Inc | Manufacturer | 2 | Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief; Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief |
| Integra LifeSciences Production Corporation | Manufacturer | 2 | Shunt, Central Nervous System And Components |
| The Ruhof Corporation | Manufacturer | 2 | Endoscope Channel Accessory; Endoscopic Irrigation/Suction System |
| ARCH Medical Solutions - Escondido LLC | Manufacturer | 1 | Appliance, Fixation, Spinal Intervertebral Body |
| Genadyne Biotechnologies, Inc. | Manufacturer | 1 | Negative Pressure Wound Therapy Powered Suction Pump |
| Surgical Theater, Inc. | Manufacturer | 1 | Orthopedic Augmented Reality |
| Anholt Technologies Inc. | Manufacturer | 1 | Accelerator, Linear, Medical |
| Curveassure Inc. | Manufacturer | 1 | Interactive Rehabilitation Exercise Device, Prescription Use |
| Analytics For Life Inc. | Manufacturer | 1 | Computer, Diagnostic, Programmable |
| Curemetrix, Inc. | Manufacturer | 1 | Automated Radiological Image Processing Software |
| Led Intellectual Properties LLC | Manufacturer | 2 | Light Based Over The Counter Wrinkle Reduction; Over-The-Counter Powered Light Based Laser For Acne |
| Applied Lacquer Industries, Inc. | Manufacturer | 1 | Lamp, Infrared, Therapeutic Heating |
| Q3 Medical USA, LLC | Manufacturer | 1 | Stents, Drains And Dilators For The Biliary Ducts |
| Augmedics Ltd. | Manufacturer | 1 | Orthopedic Augmented Reality |
| Parallel Robotics, LLC | Manufacturer | 1 | Laparoscope, General & Plastic Surgery |
| Archy Dental, Inc. | Manufacturer | 1 | System, Image Processing, Radiological |
| Applied Medical Resources Corp. | Manufacturer | 2 | Ring (Wound Protector), Drape Retention, Internal; Illuminator, Non-Remote |
| Tigon Medical LLC | Manufacturer | 1 | Fastener, Fixation, Nondegradable, Soft Tissue |
| Smith & Nephew Inc. | Manufacturer | 2 | Fastener, Fixation, Nondegradable, Soft Tissue; Intra-Articular Orthopedic Stereotaxic Navigation Instrument |
| Eyekon Medical, Inc. | Manufacturer | 1 | Keratoprosthesis, Temporary Implant, Surgical Use |
| Lung Bioengineering Inc | Manufacturer | 1 | Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs |
| Candelis, Inc. | Manufacturer | 1 | System, Image Processing, Radiological |
| Micro Therapeutics, Inc. Dba Ev3 Neurovascular | Manufacturer | 2 | Catheter, Thrombus Retriever; Device, Vascular, For Promoting Embolization |
| Vilex LLC | Manufacturer | 9 | Starter, Bone Screw; Impactor; Orthopedic Manual Surgical Instrument; Gauge, Depth; Passer, Wire, Orthopedic; Reamer; Guide, Surgical, Instrument; Bit, Drill; Tray, Surgical, Instrument |
| Control Bionics Inc. | Manufacturer | 1 | Device, Biofeedback |
| Quest Diagnostics Nichols Institute | Manufacturer | 1 | Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors |
| Warsaw Orthopedic, Inc. | Manufacturer | 2 | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Brasseler U.S.A. Dental, LLC | Manufacturer | 2 | Endodontic Kit; Dental Prophylaxis Kit |
| Cynosure, LLC | Manufacturer | 1 | Powered Laser Surgical Instrument |
| Koios Medical, Inc. | Manufacturer | 2 | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer; Automated Radiological Image Processing Software |
| Think Interfaces LLC | Manufacturer | 1 | Device, Biofeedback |
| Intuitive Surgical, Inc. | Manufacturer | 1 | Laparoscope, General & Plastic Surgery |
| Gn Consumer Hearing Corporation | Manufacturer | 2 | Hearing Aid, Air-Conduction With Wireless Technology, Prescription; Self-Fitting Air-Conduction Hearing Aid, Over The Counter |
| Nvision Biomedical Technologies, Inc | Manufacturer | 1 | Plate, Fixation, Bone |
| Maine Molecular Quality Controls, Inc. | Manufacturer | 1 | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays |
| North American Rescue, LLC. | Manufacturer | 5 | Burn Kit Without Drug; Airway Suction Kit; Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear); Device, Intravascular Catheter Securement; Kit, Surgical Instrument, Disposable |
| Empirical Spine, Inc. | Manufacturer | 2 | Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| OptraSCAN Inc. | Manufacturer | 1 | Microscope, Automated, Image Analysis, Operator Intervention |
| Formlabs Ohio, Inc. | Manufacturer | 1 | Resin, Denture, Relining, Repairing, Rebasing |
| embecta medical I LLC | Manufacturer | 2 | Syringe, Antistick; Syringe, Piston |
| Cochlear Americas Warehouse | Manufacturer | 1 | Active Implantable Bone Conduction Hearing System |
| Cytovale, Inc. | Manufacturer | 1 | Deformability Cytometry For Sepsis Risk Assessment |
| Protaryx Medical, LLC | Manufacturer | 2 | Introducer, Catheter; Dilator, Vessel, For Percutaneous Catheterization |
| Chembio Diagnostic Systems, Inc. | Manufacturer | 1 | Antigens, Nontreponemal, All |
| DiaSorin Molecular LLC | Manufacturer | 2 | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System; Real Time Nucleic Acid Amplification System |
| Infinity Neuro, LLC | Manufacturer | 1 | Catheter, Percutaneous |
| Omec Medical NV Inc | Manufacturer | 2 | Speculum, Rectal; Laparoscope, General & Plastic Surgery |
| Oculogica - Backburner Labs Inc. | Manufacturer | 1 | Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid |
| OpenMotion AI, Inc. | Manufacturer | 1 | Interactive Rehabilitation Exercise Device, Prescription Use |
| Cortechs Labs, Inc. | Manufacturer | 2 | System, Image Processing, Radiological; Automated Radiological Image Processing Software |
| Halyard North Carolina, LLC | Manufacturer | 2 | Wrap, Sterilization |
| Alcyone Therapeutics, Inc. | Manufacturer | 1 | Catheter, Percutaneous, Long Term, Intraspinal |
| Asclepius Medical Holdings LLC | Manufacturer | 1 | Lamp, Infrared, Therapeutic Heating |
| Ortho-Clinical Diagnostics, Inc. | Manufacturer | 1 | Calibrator, Secondary |
| Ge Medical Systems, LLC | Manufacturer | 1 | System, X-Ray, Tomography, Computed |
| Biohorizons Implant Systems Inc. | Manufacturer | 2 | Abutment, Implant, Dental, Endosseous; Dental Abutment Design Software For Dental Laboratory |
| PULMONX, Corp. | Manufacturer | 1 | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) |
| Intuitive Surgical, Inc. | Manufacturer | 1 | Insufflator, Laparoscopic |
| Electrowire Corporation Dba Electrowire Medical | Manufacturer | 1 | Catheter, Septostomy |
| Hiossen Inc. | Manufacturer | 1 | Abutment, Implant, Dental, Endosseous |
| Germaine Laboratories, Inc. | Manufacturer | 2 | Devices Detecting Influenza A, B, And C Virus Antigens; Multi-Analyte Respiratory Virus Antigen Detection Test |
| Gramercy Extremity Orthopedics, LLC. | Manufacturer | 9 | Countersink; Tap, Bone; Bender; Orthopedic Manual Surgical Instrument; Gauge, Depth; Bit, Drill; Template; Reamer; Staple Driver |
| Abbott Molecular, Inc. | Manufacturer | 2 | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents; Applicator, Absorbent Tipped, Sterile |
| FUJIFILM Healthcare Americas Corporation | Manufacturer | 1 | Automated Radiological Image Processing Software |
| Canon Medical Informatics, Inc. | Manufacturer | 1 | Automated Radiological Image Processing Software |
| Transtimulation Research Inc | Manufacturer | 1 | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Cryodressing, Inc | Manufacturer | 1 | Pack, Hot Or Cold, Water Circulating |
| Advanced Instrumentations, Inc. | Manufacturer | 1 | Gas-Machine, Anesthesia |
| IMMY, Inc. | Manufacturer | 2 | Candida Species Nucleic Acid Detection System; Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens |
| Bausch & Lomb Incorporated | Manufacturer | 1 | Instrument, Vitreous Aspiration And Cutting, Ac-Powered |
| Regenlab USA LLC | Manufacturer | 1 | Platelet And Plasma Separator For Bone Graft Handling |
| Revmedx, Inc. | Manufacturer | 2 | Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use; Gauze / Sponge,Nonresorbable For External Use |
| Somnomed Inc. | Manufacturer | 1 | Device, Anti-Snoring |
| Advanced Telesensors, Inc. | Manufacturer | 1 | Oscillometer |
| Buoy Software LLC | Manufacturer | 1 | Blood Establishment Computer Software And Accessories |
| Ortho-Clinical Diagnostics, Inc. | Manufacturer | 1 | Bromcresol Purple Dye-Binding, Albumin |
| Penumbra, Inc. | Manufacturer | 1 | Catheter, Thrombus Retriever |
| Penumbra Inc. | Manufacturer | 1 | Catheter, Thrombus Retriever |
| Penumbra Inc. | Manufacturer | 1 | Catheter, Thrombus Retriever |
| Miridia Technology Inc. | Manufacturer | 1 | Locator, Acupuncture Point |
| Becton, Dickinson & Co. | Manufacturer | 2 | Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay; System, Blood Culturing |
| Spectral Md, Inc. | Manufacturer | 1 | Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment. |
| Penumbra Inc. | Manufacturer | 1 | Catheter, Thrombus Retriever |
| 3b Medical Inc | Manufacturer | 2 | Ventilator, Continuous, Non-Life-Supporting; Ventilator, Non-Continuous (Respirator) |
| Arteriocyte Medical Systems, Inc. | Manufacturer | 1 | Platelet And Plasma Separator For Bone Graft Handling |
| Simergent, LLC | Manufacturer | 1 | System, Peritoneal, Automatic Delivery |
| Orthogrid Systems, Inc | Manufacturer | 2 | Instrument, Quality-Assurance, Radiologic; Automated Radiological Image Processing Software |
| Nelson Environmental Technologies, Inc. | Manufacturer | 1 | Strip, Test, Reagent, Residuals For Dialysate, Disinfectant |
| Retmap, Inc. | Manufacturer | 1 | Electrode, Corneal |
| Accurkardia Inc. | Manufacturer | 2 | Electrocardiograph; Computer, Diagnostic, Programmable |
| Envision Endoscopy Inc. | Manufacturer | 2 | Endoscopic Tissue Approximation Device; Endoscopic Grasping/Cutting Instrument, Non-Powered |
| In2bones USA, LLC | Manufacturer | 2 | Plate, Fixation, Bone; Screw, Fixation, Bone |
| Exelint International, Co. | Manufacturer | 1 | Needle, Hypodermic, Single Lumen |
| Prowess, Inc. | Manufacturer | 1 | System, Planning, Radiation Therapy Treatment |
| Ethicon, LLC. | Manufacturer | 1 | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Ethicon, Inc. | Manufacturer | 2 | Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Surgical, Absorbable, Polydioxanone |
| Optum Distribution Center, LLC | Manufacturer | 1 | System, Test, Blood Glucose, Over The Counter |
| Amp Health Inc | Manufacturer | 1 | Interactive Rehabilitation Exercise Device, Prescription Use |
| Clarus Medical, LLC. | Manufacturer | 1 | Arthroscope |
| Luminex Corporation | Manufacturer | 2 | Instrumentation For Clinical Multiplex Test Systems; Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System |
| Eiger Diagnostics, Inc. | Manufacturer | 3 | Device, General Purpose, Microbiology, Diagnostic; Enzyme Linked Immunosorbent Assay, T. Cruzi; Reagent, Leishmanii Serological |

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