DeviceEstablishmentPulse: U.S. establishment, 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).
| Record | Role | New listings | Devices |
|---|---|---|---|
| Stellmacher Instruments Inc | Repackager or relabeler | 30 | Handle, Scalpel; Punch, Corneo-Scleral; Cable, Electrode; Dilator, Lachrymal; Retractor, Ophthalmic; Probe, Lachrymal; Orthopedic Manual Surgical Instrument; Scissors, Medical, Disposable; Cannula, Ophthalmic; Marker, Skin |
| Lumitex Medical Devices, Inc. | Contract manufacturer | 1 | Intraoral Phototherapy Device |
| Merz North America, Inc. | Other | 4 | Implant, Dermal, For Aesthetic Use; System, Imaging, Pulsed Echo, Ultrasonic; Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption |
| Alom Technologies Corporation | Contract manufacturer | 2 | Dna Specimen Collection, Saliva; Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Boulder Biomed LLC | Contract sterilizer | 2 | Clamp, Vascular; Fastener, Fixation, Nondegradable, Soft Tissue |
| Primo Medical Group, INC | Contract manufacturer | 2 | Fastener, Fixation, Nondegradable, Soft Tissue; Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Clarity Design, Inc. | Contract manufacturer | 2 | Marker, Radiographic, Implantable; Device, Biofeedback |
| Synergy Health AST, LLC | Contract sterilizer | 1 | Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter |
| Isomedix Operations Inc | Contract sterilizer | 1 | Needle, Hypodermic, Single Lumen |
| Medalliance, LLC | Manufacturer | 1 | Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter |
| Covidien | Manufacturer | 2 | Electrosurgical, Cutting & Coagulation & Accessories; Modular Electromechanical Surgical System |
| Covidien | Specification developer (outsources manufacturing) | 2 | Electrosurgical, Cutting & Coagulation & Accessories; Modular Electromechanical Surgical System |
| Paragon Implant Mfg., LLC | Manufacturer | 2 | Abutment, Implant, Dental, Endosseous; Implant, Endosseous, Root-Form |
| Argus Cognitive, Inc. | Manufacturer | 1 | Automated Radiological Image Processing Software |
| Paragon Implant Company, LLC | Manufacturer | 2 | Implant, Endosseous, Root-Form; Abutment, Implant, Dental, Endosseous |
| Axora Medical, Inc. | Specification developer (outsources manufacturing) | 1 | Hysteroscope (And Accessories) |
| Isomedix Operations Inc. | Manufacturer | 1 | Device, Monitoring, Intracranial Pressure |
| Dynapulse Medical LLC | Specification developer (outsources manufacturing) | 1 | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Avid Medical, Inc. A Medical Action Ind. Company 305 | Manufacturer | 4 | Truss, Umbilical; Surgeon'S Gloves; Medical Glove, Specialty |
| Medical Action Industries, Inc. 306 | Manufacturer | 4 | Medical Glove, Specialty; Surgeon'S Gloves; Truss, Umbilical |
| Innovacyn, Inc. | Manufacturer | 2 | Dressing, Wound, Drug; Lavage, Jet |
| Trend Medical, LLC | Specification developer (outsources manufacturing) | 4 | Splint, Hand, And Components; Joint, Hip, External Brace; Sling, Arm, Overhead Supported; Sling, Arm |
| 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 |
| B. Braun Medical Inc. | Specification developer (outsources manufacturing) | 1 | System, Irrigation, Urological |
| Hologic, Inc. | Specification developer (outsources manufacturing) | 1 | Electrosurgical, Cutting & Coagulation & Accessories |
| 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 |
| Total Joint Orthopedics, Inc. | Specification developer (outsources manufacturing) | 2 | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Bone Cement, Antibiotic |
| Ascensia Diabetes Care US Inc. | Specification developer (outsources manufacturing) | 1 | System, Test, Blood Glucose, Over The Counter |
| Prismatik Dentalcraft, Inc. | Manufacturer | 2 | Resin, Denture, Relining, Repairing, Rebasing; Powder, Porcelain |
| Emboline Inc | Manufacturer | 1 | Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures |
| Ascensia Diabetes Care US Inc. | Specification developer (outsources manufacturing) | 1 | System, Test, Blood Glucose, Over The Counter |
| 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 |
| Pulmera Inc. | Specification developer (outsources manufacturing) | 2 | System, X-Ray, Tomography, Computed; Interventional Fluoroscopic X-Ray System |
| 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 |
| Simple Style Inc | Specification developer (outsources manufacturing) | 10 | Bandage, Elastic; Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use; First Aid Kit Without Drug; Pad, Alcohol, Device Disinfectant; Tourniquet, Nonpneumatic; Orthosis, Limb Brace; Tape And Bandage, Adhesive; Applicator, Absorbent Tipped, Sterile; Bedding, Disposable, Medical; Gauze / Sponge,Nonresorbable For External Use |
| Global Life Sciences Solutions USA LLC | Specification developer (outsources manufacturing) | 1 | Filter, Infusion Line |
| Secured Ortho Manufacturing Of America, LLC | Specification developer (outsources manufacturing) | 2 | Sleeve, Limb, Compressible |
| 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 |
| Neuronetics Inc. | Specification developer (outsources manufacturing) | 1 | Transcranial Magnetic Stimulator |
| 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 |
| Congruence Medical Solutions, LLC | Specification developer (outsources manufacturing) | 2 | Ophthalmic Syringe; Syringe, Piston |
| Alcon Research, LLC | Specification developer (outsources manufacturing) | 2 | Laser, Ophthalmic; Drape, Surgical, Exempt |
| 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 |
| Mcsc Medical LLC | Specification developer (outsources manufacturing) | 1 | Spirometer, Therapeutic (Incentive) |
| Medgyn Products, Inc. | Manufacturer | 2 | Electrocautery, Gynecologic (And Accessories); Catheter, Nasopharyngeal |
| First Nation Group, LLC | Specification developer (outsources manufacturing) | 2 | Mattress, Flotation Therapy, Non-Powered; Bed, Ac-Powered Adjustable Hospital |
| 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 |
| CHS USA Incorporated | Specification developer (outsources manufacturing) | 2 | Syringe, Piston; Needle, Hypodermic, Single Lumen |
| Nessa Global Inc. | Specification developer (outsources manufacturing) | 2 | Lipoaspirate Washing System For Aesthetic Body Contouring; Syringe, Piston |
| Nova Vascular LLC | Specification developer (outsources manufacturing) | 2 | Introducer, Catheter |
| NEUROCAREAI INC (DBA SaveLife.AI) | Manufacturer | 1 | Radiological Computer-Assisted Prioritization Software For Lesions |
| Boston Insilico Medical Solutions LLC | Specification developer (outsources manufacturing) | 1 | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| 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 |
| Nexus Spine, L.L.C. | Specification developer (outsources manufacturing) | 1 | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Zsfab Inc | Specification developer (outsources manufacturing) | 2 | Intervertebral Fusion Device With Integrated Fixation, Cervical; Intervertebral Fusion Device With Bone Graft, Cervical |
| Nobel Biocare USA, LLC | Manufacturer | 2 | Dental Abutment Design Software For Dental Laboratory; Abutment, Implant, Dental, Endosseous |
| Nexus Spine, LLC. | Specification developer (outsources manufacturing) | 1 | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| O&S Dental, Inc. | Manufacturer | 1 | Unit, X-Ray, Intraoral |
| Fainteer Limited | Manufacturer | 1 | Pulse Oximeter For Over-The-Counter Use |
| Carbon, Inc. | Specification developer (outsources manufacturing) | 1 | Resin, Denture, Relining, Repairing, Rebasing |
| 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 |
| Genadyne Biotechnologies, Inc. | Specification developer (outsources manufacturing) | 1 | Negative Pressure Wound Therapy Powered Suction Pump |
| Bluewind Medical, Inc. | Specification developer (outsources manufacturing) | 1 | Implanted Tibial Electrical Urinary Continence Device |
| 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 |
| Gfa Production Inc | Specification developer (outsources manufacturing) | 25 | Finger Cot; Protector, Skin Pressure; Forceps; Dressing, Wound, Hydrogel Without Drug And/Or Biologic; Stapler, Skin; Pack, Hot Or Cold, Disposable; Brush, Scrub, Operating-Room; Bedding, Disposable, Medical; Gauze / Sponge,Nonresorbable For External Use; Bandage, Cast |
| Spirair, Inc | Specification developer (outsources manufacturing) | 1 | Polymer, Ear, Nose And Throat, Synthetic, Absorbable |
| Hartman Medical Group,LLC | Specification developer (outsources manufacturing) | 2 | Introducer, Catheter; Set, Administration, Intravascular |
| 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 |
| Smith & Nephew Inc. | Specification developer (outsources manufacturing) | 2 | Intra-Articular Orthopedic Stereotaxic Navigation Instrument; Fastener, Fixation, Nondegradable, Soft Tissue |
| 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 |
| Affirm Medical Technologies II, LLC | Specification developer (outsources manufacturing) | 1 | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
| 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 |
| Nucare LLC | Specification developer (outsources manufacturing) | 4 | Latex Patient Examination Glove; Accessories, Retractor, Dental; Finger Cot |
| 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 |
| Amaze Neuro, Inc. | Specification developer (outsources manufacturing) | 1 | Device, Biofeedback |
| 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 |
| Livemedica, LLC | Specification developer (outsources manufacturing) | 1 | System, Image Processing, Radiological |
| Takeda Pharmaceuticals U.S.A., Inc. | Specification developer (outsources manufacturing) | 1 | Parenteral Administration Kit |
| Tas Medical, Inc. | Specification developer (outsources manufacturing) | 1 | Suture, Nonabsorbable, Synthetic, Polyamide |
| Eko Health, Inc. | Specification developer (outsources manufacturing) | 1 | Stethoscope, Electronic |
| Assure Tech LLC | Specification developer (outsources manufacturing) | 2 | Over-The-Counter Covid-19 Antigen Test; Sperm, Antigen, Antiserum, Control |
| Spine Innovation, LLC | Specification developer (outsources manufacturing) | 1 | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Dreame Technology USA Inc | Specification developer (outsources manufacturing) | 4 | Floss, Dental; Toothbrush, Powered; Unit, Oral Irrigation; Toothbrush, Manual |
| 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 |
| Joylux, Inc. | Specification developer (outsources manufacturing) | 2 | Lubricant, Personal; Lamp, Infrared, Therapeutic Heating |
| Think Interfaces LLC | Manufacturer | 1 | Device, Biofeedback |
| Prapela, Inc. | Specification developer (outsources manufacturing) | 1 | Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome |
| Intuitive Surgical, Inc. | Manufacturer | 1 | Laparoscope, General & Plastic Surgery |
| Spiro Robotics Inc. | Specification developer (outsources manufacturing) | 1 | Tube, Tracheal (W/Wo Connector) |
| Gn Consumer Hearing Corporation | Manufacturer | 2 | Hearing Aid, Air-Conduction With Wireless Technology, Prescription; Self-Fitting Air-Conduction Hearing Aid, Over The Counter |
| Promaxo, LLC | Specification developer (outsources manufacturing) | 2 | System, Nuclear Magnetic Resonance Imaging; Coil, Magnetic Resonance, Specialty |
| 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 |
| Spinal Surgical Strategies, Inc | Specification developer (outsources manufacturing) | 1 | Intervertebral Fusion Device With Bone Graft, Lumbar |
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