DeviceEstablishmentPulse: U.S. 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 |
|---|---|---|---|
| Isomedix Operations, Inc. | Contract sterilizer | 124 | Starter, Bone Screw; Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer; Prosthesis, Ankle, Uncemented, Non-Constrained; Fastener, Fixation, Nondegradable, Soft Tissue; Hemostatic Wound Dressing Without Thrombin Or Other Biologics; Plate, Fixation, Bone; Screw, Fixation, Bone; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Shoulder Prosthesis, Reverse Configuration; Filler, Bone Void, Calcium Compound |
| Isomedix Operations Inc. | Contract sterilizer | 8 | Drills, Burrs, Trephines & Accessories (Manual); Drills, Burrs, Trephines & Accessories (Simple, Powered); Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Catheter, Septostomy; Pump, Infusion, Insulin Bolus; Pump, Infusion, Insulin; Snare, Flexible |
| C.R. Bard, Inc. | Contract sterilizer | 10 | Catheter, Flow Directed; Transducer, Pressure, Catheter Tip; Catheter, Oximeter, Fiber-Optic; Transducer, Blood-Pressure, Extravascular; Mesh, Surgical, Polymeric; Mesh, Surgical, Absorbable, Abdominal Hernia; Surgical Film; Catheter, Continuous Flush; Plethysmograph, Impedance; Probe, Thermodilution |
| Isomedix Operations, Inc. | Contract sterilizer | 7 | Percutaneous Catheter, Ultrasound; Catheter, Retention Type, Balloon; Stylet, Catheter; Catheter, Electrode Recording, Or Probe, Electrode Recording; Stimulator, Spinal-Cord, Implanted (Pain Relief); Stimulator, Spinal-Cord, Totally Implanted For Pain Relief; Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy |
| Isomedix Operations, Inc. | Contract sterilizer | 12 | Electrosurgical, Cutting & Coagulation & Accessories; Intervertebral Body Graft Containment Device; Catheter, Percutaneous; Electrode, Depth; Dilator, Esophageal; Stents, Drains And Dilators For The Biliary Ducts; Device, Vascular, For Promoting Embolization; Negative Pressure Wound Therapy Powered Suction Pump |
| Bard Shannon Limited | Contract manufacturer | 3 | Mesh, Surgical, Polymeric; Mesh, Surgical, Absorbable, Abdominal Hernia; Surgical Film |
| Cook Medical LLC | Contract manufacturer | 4 | Tube, Tracheal (W/Wo Connector); Wire, Guide, Catheter; Catheter, Urological; Catheter, Ureteral, Gastro-Urology |
| Swiss-American CDMO,LLC | Contract manufacturer | 4 | Dressing, Wound, Drug; Lubricant, Personal; Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible |
| Millstone Medical Outsourcing LLC. | Contract manufacturer | 24 | Peripheral Blood Processing Device For Wound Management; Thoracolumbosacral Pedicle Screw System; Needle, Suturing, Disposable; Orthopedic Augmented Reality; Orthopedic Stereotaxic Instrument; Intervertebral Fusion Device With Bone Graft, Cervical; Shoulder Prosthesis, Reverse Configuration; Intervertebral Fusion Device With Bone Graft, Thoracic; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Bone Graft, Lumbar |
| Orchid Orthopedic Solutions Oregon, Inc. | Contract manufacturer | 3 | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
| Philips Ultrasound LLC | Contract manufacturer | 32 | Transducer, Ultrasonic, Diagnostic; Automated Radiological Image Processing Software; System, Image Processing, Radiological; Catheter, Ultrasound, Intravascular; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer |
| Sterigenics US LLC | Contract sterilizer | 8 | Device, Surgical, Cryogenic; Stimulator, Nerve; Device, Monitoring, Intracranial Pressure; Catheter, Continuous Flush |
| Zimmer, Inc. | Contract manufacturer | 28 | Screw, Fixation, Bone; Plate, Fixation, Bone; Washer, Bolt Nut; Cerclage, Fixation; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained; Stimulator, Nerve |
| Isomedix Operations Inc. | Contract sterilizer | 16 | Sealant, Microbial; Cannula, Catheter; Wire, Guide, Catheter; Trocar; Introducer, Catheter; Device, Impotence, Mechanical/Hydraulic; Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Isomedix Operations Inc. | Contract sterilizer | 26 | Orthopedic Stereotaxic Instrument; Wax, Bone; Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside; Methyl Methacrylate For Cranioplasty; Filler, Bone Void, Calcium Compound; Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation; Dura Substitute; Hemostatic Wound Dressing Without Thrombin Or Other Biologics |
| Isomedix Operations Inc. | Contract sterilizer | 3 | Dressing, Wound, Drug; Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside; Dura Substitute |
| Arthrex, Inc. | Contract manufacturer | 10 | Screw, Fixation, Bone; Prosthesis, Elbow, Hemi-, Radial, Polymer; Fastener, Fixation, Biodegradable, Soft Tissue; Fastener, Fixation, Nondegradable, Soft Tissue; Staple, Fixation, Bone |
| Arthrex Manufacturing Inc. | Contract manufacturer | 7 | Fastener, Fixation, Biodegradable, Soft Tissue; Fastener, Fixation, Nondegradable, Soft Tissue; System, Facet Screw Spinal Device; Screw, Fixation, Bone |
| Isomedix Operations Inc. | Contract sterilizer | 18 | Introducer, Catheter; Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use; Fastener, Fixation, Nondegradable, Soft Tissue; Clamp, Vascular; Screw Sleeve Bone Fixation Device, Spine; Thoracolumbosacral Pedicle Screw System; Hydrogel Spacer; Prosthesis, Vascular Graft, Of Less Then 6mm Diameter; Prosthesis, Vascular Graft, Of 6mm And Greater Diameter; Appliance, Fixation, Spinal Interlaminal |
| Surgical Instrument Manufacturers, LLC | Contract manufacturer | 13 | Sacroiliac Joint Fixation; Intervertebral Fusion Device With Bone Graft, Lumbar; Spinal Vertebral Body Replacement Device; Intervertebral Fusion Device With Integrated Fixation, Cervical; Thoracolumbosacral Pedicle Screw System; Appliance, Fixation, Spinal Interlaminal; Intervertebral Fusion Device With Bone Graft, Cervical; Orthosis, Spinal Pedicle Fixation; Orthosis, Spondylolisthesis Spinal Fixation |
| EPIC MedTec OEM Catheter & Wire LLC | Contract manufacturer | 14 | Introducer, Catheter; Transducer, Pressure, Catheter Tip; Catheter, Percutaneous; Port & Catheter, Implanted, Subcutaneous, Intravascular; Stent, Ureteral; Accessories, Catheter, G-U; Set, Administration, Intravascular |
| Mastel Surgical Inc. | Contract manufacturer | 4 | Nebulizer, Medicinal, Non-Ventilatory (Atomizer); Blower, Powder, Ent; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Syringe, Ent |
| C.R. Bard, Inc. | Contract sterilizer | 11 | Plethysmograph, Impedance; Transducer, Blood-Pressure, Extravascular; Catheter, Continuous Flush; Transducer, Pressure, Catheter Tip; Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit); Probe, Thermodilution; Catheter, Flow Directed; Tubes, Gastrointestinal (And Accessories); Catheter, Oximeter, Fiber-Optic; Introducer, Catheter |
| Precision Edge Surgical Products Company | Contract manufacturer | 3 | Orthopedic Stereotaxic Instrument; Staple, Fixation, Bone; Screw, Fixation, Bone |
| Zigg Design LLC | Contract manufacturer | 33 | Orthosis, Spine, Plate, Laminoplasty, Metal; Posterior Cervical Screw System; Appliance, Fixation, Spinal Interlaminal; Intervertebral Fusion Device With Bone Graft, Lumbar; Thoracolumbosacral Pedicle Screw System; Appliance, Fixation, Spinal Intervertebral Body; Sacroiliac Joint Fixation; Intervertebral Fusion Device With Bone Graft, Cervical; System, Facet Screw Spinal Device; Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Universal Brain Inc. | Specification developer (outsources manufacturing) | 3 | Stimulator, Auditory, Evoked Response; Non-Normalizing Quantitative Electroencephalograph Software; Full-Montage Standard Electroencephalograph |
| 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 |
| Covidien | Specification developer (outsources manufacturing) | 5 | Tube, Tracheal (W/Wo Connector); Burst Suppression Detection Software For Electroencephalograph; Index-Generating Electroencephalograph Software; Reduced- Montage Standard Electroencephalograph; Non-Normalizing Quantitative Electroencephalograph Software |
| 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 |
| Sxwell USA LLC | Specification developer (outsources manufacturing) | 4 | Lubricant, Personal |
| 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 | 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 |
| Lightning X Products, Inc | Manufacturer | 32 | Airway, Oropharyngeal, Anesthesiology; Orthosis, Cervical; Forceps; Tape And Bandage, Adhesive; Pack, Hot Or Cold, Disposable; Stethoscope, Manual; Polymer Patient Examination Glove; Pad, Eye; Mask, Oxygen, Non-Rebreathing; Bedding, Disposable, Medical |
| Draeger Medical Systems, Inc. | Manufacturer | 17 | Continuous Measurement Thermometer; System, Network And Communication, Physiological Monitors; Computer, Blood-Pressure; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms); Recorder, Paper Chart; System, Measurement, Blood-Pressure, Non-Invasive; Cable, Transducer And Electrode, Patient, (Including Connector); Monitor, Breathing Frequency; Plethysmograph, Impedance; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
| Butterfly Network, Inc. | Specification developer (outsources manufacturing) | 4 | Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; Automated Radiological Image Processing Software |
| Roche Molecular Systems, Inc. | Manufacturer | 4 | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System; Dna-Reagents, Neisseria; Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections; Dna Probe, Nucleic Acid Amplification, Chlamydia |
| Radformation, Inc. | Manufacturer | 3 | Radiological Image Processing Software For Radiation Therapy; System, Planning, Radiation Therapy Treatment; Accelerator, Linear, Medical |
| Roche Molecular Systems, Inc. | Specification developer (outsources manufacturing) | 4 | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System; Dna-Reagents, Neisseria; Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections; Dna Probe, Nucleic Acid Amplification, Chlamydia |
| Endologix LLC | Specification developer (outsources manufacturing) | 3 | Peripheral Mechanical Thrombectomy With Aspiration |
| Datex-Ohmeda, Inc. | Specification developer (outsources manufacturing) | 3 | System, Monitoring, Perinatal; Incubator, Neonatal; Warmer, Infant Radiant |
| Fiagon Na LLC | Manufacturer | 3 | Balloon, Nasal Airway; Eustachian Tube Balloon Dilation Device; Instrument, Ent Manual Surgical |
| 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; Anti-Ss-A Ro60 Autoantibodies; Anti-Ss-A 52 Autoantibodies; Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm); Test System, Antineutrophil Cytoplasmic Antibodies (Anca) |
| Spine Wave, Inc. | Manufacturer | 6 | Bit, Drill; Gauge, Depth; Guide, Surgical, Instrument; Intervertebral Fusion Device With Bone Graft, Lumbar; Bone Cement, Posterior Screw Augmentation; Thoracolumbosacral Pedicle Screw System |
| Hsg-S Corp | Manufacturer | 20 | Carrier, Amalgam, Operative; Cleanser, Root Canal; Dam, Rubber; Resin, Root Canal Filling; Gauge, Depth, Instrument, Dental; Explorer, Operative; Instrument, Filling, Plastic, Dental; Instrument, Diamond, Dental; Plugger, Root Canal, Endodontic; Locator, Root Apex |
| Siemens Healthcare Diagnostics Inc. | Specification developer (outsources manufacturing) | 9 | Colorimetry, Acetaminophen; Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125); System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer; Single (Specified) Analyte Controls (Assayed And Unassayed); Bilirubin (Total And Unbound) In The Neonate Test System; Diazo Colorimetry, Bilirubin; System, Test, Immunological, Antigen, Tumor; System, Test, Carcinoembryonic Antigen; Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions |
| Siemens Healthcare Diagnostics Inc. | Manufacturer | 5 | Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions; System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer; Single (Specified) Analyte Controls (Assayed And Unassayed); System, Test, Carcinoembryonic Antigen; Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) |
| Auris Health, Inc | Manufacturer | 3 | Integrated Operating Table-Electromechanical Surgical System; System, X-Ray, Tomography, Computed; Bronchoscope (Flexible Or Rigid) |
| SunMed Group Holdings, LLC | Specification developer (outsources manufacturing) | 9 | Blood Pressure Cuff; Tube, Tracheal (W/Wo Connector); Humidifier, Respiratory Gas, (Direct Patient Interface); Mask, Oxygen; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
| MC3, Inc. | Specification developer (outsources manufacturing) | 4 | Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure; Oxygenator, Long Term Support Greater Than 6 Hours; Tubing, Long Term Support Greater Than 6 Hours; Blood Pump For Ecmo, Long-Term (> 6 Hours) Use |
| Ultradent Products Inc. | Manufacturer | 3 | Varnish, Cavity; Material, Tooth Shade, Resin; Adhesive, Bracket And Tooth Conditioner, Resin |
| 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 | Instrument, Ligature Tucking, Orthodontic; Bracket, Metal, Orthodontic; Instrument, Filling, Plastic, Dental; Instruments, Dental Hand; Aligner, Sequential; Spring, Orthodontic; Wax, Dental, Intraoral; Plier, Orthodontic; Accessories, Retractor, Dental; Band, Elastic, Orthodontic |
| Aesthetic Protools, Inc. | Specification developer (outsources manufacturing) | 3 | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect; Powered Laser Surgical Instrument |
| Siemens Healthcare Diagnostics Inc. | Manufacturer | 3 | Bilirubin (Total And Unbound) In The Neonate Test System; Diazo Colorimetry, Bilirubin; Colorimetry, Acetaminophen |
| Sight Sciences, Inc. | Specification developer (outsources manufacturing) | 3 | Pump, Infusion, Ophthalmic; Trabeculotome; Eyelid Thermal Pulsation System |
| HR PHARMACEUTICALS, INC d/b/a HR HealthCare | Manufacturer | 4 | Collector, Urine, Powered, Non Indwelling Catheter; Drape, Surgical, Exempt; Catheter, Straight; Table, Cystometric, Electric |
| Pascall Systems Inc | Manufacturer | 4 | Reduced- Montage Standard Electroencephalograph; Non-Normalizing Quantitative Electroencephalograph Software; Electrode, Cutaneous; Burst Suppression Detection Software For Electroencephalograph |
| Merit Medical Systems, Inc. | Manufacturer | 7 | Endoscopic Access Overtube, Gastroenterology-Urology; Dilator, Vessel, For Percutaneous Catheterization; Catheter, Embolectomy; Unit, Cryosurgical, Accessories; Endoscopic Irrigation/Suction System |
| 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 | Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users; Blood, Occult, Colorimetric, In Urine; Reagents, Cysticercosis; Radioimmunoassay, Estrone; Devices Detecting Influenza A, B, And C Virus Antigens; Enzyme Linked Immunoabsorbent Assay, Mumps Virus |
| 3-D Matrix, Inc. | Manufacturer | 4 | Hemostatic Device For Endoscopic Gastrointestinal Use; Protective Coating, Mucoadhesive Application, For The Rectal Mucosa |
| Trimed, Inc. | Manufacturer | 4 | Screw, Fixation, Bone; Plate, Fixation, Bone |
| Howmedica Osteonics Corp | Manufacturer | 11 | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Cement Obturator; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer |
| Endure Industries, Inc. | Specification developer (outsources manufacturing) | 14 | Cannula, Nasal, Oxygen; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Splint, Intranasal Septal; Mask, Oxygen; Scissors, Medical, Disposable; Tourniquet, Nonpneumatic; Tubing, Pressure And Accessories; Staple, Removable (Skin); Mask, Gas, Anesthetic; Ear Wick |
| Diazyme Laboratories, Inc. | Manufacturer | 3 | Lipoprotein, Low-Density, Antigen, Antiserum, Control; Ldl & Vldl Precipitation, Hdl; System, Test, Oxalate |
| S. Jackson, Inc. | Manufacturer | 4 | Suture, Nonabsorbable, Synthetic, Polyamide |
| Dexcom, Inc. | Manufacturer | 5 | Tape And Bandage, Adhesive; Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter; Integrated Continuous Glucose Monitoring System, Factory Calibrated; Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter |
| Dexcom, Inc. | Specification developer (outsources manufacturing) | 5 | Tape And Bandage, Adhesive; Integrated Continuous Glucose Monitoring System, Factory Calibrated; Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter; Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter |
| Dexcom, Inc. | Manufacturer | 3 | Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter; Tape And Bandage, Adhesive; Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter |
| GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC | Specification developer (outsources manufacturing) | 4 | Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; Automated Radiological Image Processing Software; Twister, Brace Setting |
| Depuy Orthopaedics, Inc. | Manufacturer | 12 | 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; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Orthopedic Stereotaxic Instrument; Bone Cement; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
| 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 |
| GE Medical Systems Information Technologies, Inc. | Specification developer (outsources manufacturing) | 26 | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.); Monitor, St Segment With Alarm; Full-Montage Standard Electroencephalograph; Oximeter, Ear; Detector And Alarm, Arrhythmia; Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.); Non-Normalizing Quantitative Electroencephalograph Software; Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration); Oximeter |
| GE Medical Systems Information Technologies, Inc. | Specification developer (outsources manufacturing) | 26 | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.); Monitor, St Segment With Alarm; Full-Montage Standard Electroencephalograph; Oximeter, Ear; Detector And Alarm, Arrhythmia; Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.); Non-Normalizing Quantitative Electroencephalograph Software; Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration); Oximeter |
| Globus Medical, Inc. | Manufacturer | 16 | Thoracolumbosacral Pedicle Screw System; Appliance, Fixation, Spinal Interlaminal; Growing Rod System; Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis; 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 |
| Globus Medical, Inc. | Manufacturer | 12 | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; 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 |
| Acist Medical Systems, Inc. | Manufacturer | 3 | Injector And Syringe, Angiographic; Injector, Contrast Medium, Automatic |
| BioticsAI, Inc. | Manufacturer | 3 | System, Imaging, Pulsed Doppler, Ultrasonic; Automated Radiological Image Processing Software; System, Imaging, Pulsed Echo, Ultrasonic |
| Tandem Diabetes Care, Inc. | Manufacturer | 3 | Interoperable Automated Glycemic Controller; Alternate Controller Enabled Insulin Infusion Pump |
| Teleflex Medical LLC | Specification developer (outsources manufacturing) | 4 | Suture, Surgical, Absorbable, Polydioxanone; Catheter, Percutaneous; Suture, Nonabsorbable, Synthetic, Polyethylene; Instrument, Biopsy |
| Huneo, LLC | Manufacturer | 3 | Automatic Event Detection Software For Polysomnograph With Electroencephalograph; Standard Polysomnograph With Electroencephalograph; Ventilatory Effort Recorder |
| Healgen Scientific LLC | Specification developer (outsources manufacturing) | 3 | Kit, Direct Antigen, Negative Control; Kit, Direct Antigen, Positive Control; Control, Fecal Occult Blood |
| Alphatec Spine, Inc. | Manufacturer | 10 | System, Image Processing, Radiological; Interventional Fluoroscopic X-Ray System; Automated Intraoperative Spinal Rod Bending System; System, X-Ray, Fluoroscopic, Image-Intensified; Orthopedic Stereotaxic Instrument; Appliance, Fixation, Spinal Intervertebral Body; Sacroiliac Joint Fixation; Thoracolumbosacral Pedicle Screw System; Appliance, Fixation, Spinal Interlaminal; Bone Cement, Posterior Screw Augmentation |
| Alphatec Spine, Inc. | Manufacturer | 10 | System, Image Processing, Radiological; Interventional Fluoroscopic X-Ray System; Automated Intraoperative Spinal Rod Bending System; System, X-Ray, Fluoroscopic, Image-Intensified; Orthopedic Stereotaxic Instrument; Appliance, Fixation, Spinal Intervertebral Body; Sacroiliac Joint Fixation; Thoracolumbosacral Pedicle Screw System; Appliance, Fixation, Spinal Interlaminal; Bone Cement, Posterior Screw Augmentation |
| Medtronic Sofamor Danek USA, Inc. | Specification developer (outsources manufacturing) | 5 | Intervertebral Fusion Device With Bone Graft, Lumbar; Appliance, Fixation, Spinal Interlaminal; Thoracolumbosacral Pedicle Screw System; Appliance, Fixation, Spinal Intervertebral Body |
| O&M Halyard, Inc. | Manufacturer | 11 | Wrap, Sterilization; Anti Fog Solution And Accessories, Endoscopy; Clinical Electronic Thermometer; Restraint, Protective; Dressing, Wound, Drug; Fentanyl And Other Opioid Protection Glove; Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs; Medical Glove, Specialty; Polymer Patient Examination Glove; Orthosis, Limb Brace |
| Icu Medical, Inc. | Specification developer (outsources manufacturing) | 223 | Tube, Tracheostomy (W/Wo Connector); Oximeter; Set, Administration, Intravascular; Port & Catheter, Implanted, Subcutaneous, Intravascular; Transducer, Blood-Pressure, Extravascular; Probe, Blood-Flow, Extravascular; Needle, Spinal, Short Term; Needle, Conduction, Anesthetic (W/Wo Introducer); Filter, Conduction, Anesthetic; Anesthesia Conduction Kit |
| Spinal Elements, Inc. | Manufacturer | 3 | Intervertebral Fusion Device With Bone Graft, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Icu Medical, Inc. | Specification developer (outsources manufacturing) | 45 | Pump, Infusion; Warmer, Blood, Non-Electromagnetic Radiation; Set, Administration, Intravascular; System, Thermal Regulating; Warmer, Thermal, Infusion Fluid; Accessories, Pump, Infusion; Pump, Infusion, Pca; Device, Warming. Blood And Plasma; Medical Device Data System; Infusion Safety Management Software |
| restor3d, inc. | Manufacturer | 4 | Shoulder Prosthesis, Reverse Configuration; Shoulder Arthroplasty Implantation System; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Greystone Medical, LLC | Specification developer (outsources manufacturing) | 6 | Needle, Hypodermic, Single Lumen; Syringe, Antistick; Syringe, Piston; Disinfectant, Medical Devices |
| LifeSignals, Inc. | Specification developer (outsources manufacturing) | 4 | Outpatient Cardiac Telemetry; Transmitters And Receivers, Electrocardiograph, Telephone; Electrocardiograph, Ambulatory (Without Analysis); Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Angiodynamics, Inc. | Manufacturer | 3 | System, Ablation, Microwave And Accessories |
| Angiodynamics, Inc | Manufacturer | 3 | System, Ablation, Microwave And Accessories |
| AngioDynamics, Inc. | Specification developer (outsources manufacturing) | 3 | System, Ablation, Microwave And Accessories |
| MedSource Labs, LLC | Manufacturer | 4 | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; General Purpose Dental Tray; Clinical Electronic Thermometer |
| Fujifilm Sonosite,Inc. | Manufacturer | 3 | Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic |
| Topcon Healthcare, Inc. | Manufacturer | 9 | Refractometer, Ophthalmic; Tonometer, Ac-Powered; Camera, Ophthalmic, Ac-Powered; Microscope, Specular; Tomography, Optical Coherence; Refractor, Manual, Non-Powered, Including Phoropter; Biomicroscope, Slit-Lamp, Ac-Powered; Microscope, Operating & Accessories, Ac-Powered, Ophthalmic; 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 | Lens, Intraocular, Toric Optics; Lens, Multifocal Intraocular; Extended Depth Of Focus Intraocular Lens |
| Alcon Research, LLC | Manufacturer | 3 | Extended Depth Of Focus Intraocular Lens; Lens, Intraocular, Toric Optics; Lens, Multifocal Intraocular |
| Venus Concept Inc. | Manufacturer | 7 | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect; Massager, Vacuum, Radio Frequency Induced Heat; Electrosurgical, Cutting & Coagulation & Accessories; Powered Laser Surgical Instrument |
| Venus Concept Inc. | Manufacturer | 7 | Electrosurgical, Cutting & Coagulation & Accessories; Powered Light Based Non-Laser Surgical Instrument With Thermal Effect; Massager, Vacuum, Radio Frequency Induced Heat; Powered Laser Surgical Instrument |
| Victorch Meditek, Inc. | Manufacturer | 15 | Applicator, Absorbent Tipped, Sterile; Antisera, Fluorescent, Chlamydia Spp.; Wrap, Sterilization; Device, Neurovascular Embolization; Antigen(Complexed),Prostate Specific,(Cpsa); Single (Specified) Analyte Controls (Assayed And Unassayed); Multi-Analyte Respiratory Virus Antigen Detection Test; Test, Luteinizing Hormone (Lh), Over The Counter; Control, Fecal Occult Blood; Scissors, Medical, Disposable |
| Exactech, Inc. | Manufacturer | 5 | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; 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 |
| Inter-Med, Inc. | Manufacturer | 3 | Cement, Dental; Agent, Tooth Bonding, Resin; Cord, Retraction |
| Kaz USA, Inc., A Helen of Troy Company | Specification developer (outsources manufacturing) | 4 | Clinical Electronic Thermometer; Oximeter, Infrared, Sporting, Aviation; System, Measurement, Blood-Pressure, Non-Invasive |
| Inova Diagnostics, Inc. | Manufacturer | 3 | System, Test, Anticardiolipin Immunological; System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi); System, Multipurpose For In Vitro Coagulation Studies |
| Synthes (USA) Products LLC | Specification developer (outsources manufacturing) | 5 | Plate, Cranioplasty, Preformed, Non-Alterable; Software For Diagnosis/Treatment; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Plate, Fixation, Bone |
| Zyris, Inc. | Manufacturer | 3 | Drape, Surgical, Exempt; Dental Barriers And Sleeves; Evacuator, Oral Cavity |
| Spectrawave, Inc. | Manufacturer | 17 | System, Image Processing, Radiological; X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device; System, Imaging, Optical Coherence Tomography (Oct); System, Imaging, Pulsed Echo, Ultrasonic; Catheter, Intravascular, Plaque Morphology Evaluation; Optical Coherence Tomography, Intravascular Catheter |
| 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; Cardiac Hypertrophy Machine Learning-Based Notification Software; Cardiovascular Machine Learning-Based Notification Software; Aortic Stenosis Machine Learning-Based Notification Software |
| Access Vascular, Inc | Manufacturer | 3 | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days |
| Medline Industries, LP - Spt | Manufacturer | 7 | Electrosurgical, Cutting & Coagulation & Accessories; General Surgery Tray |
| E. Benson Hood Laboratories, Inc. | Manufacturer | 13 | Bronchoscope (Flexible Or Rigid); Tube, Laryngectomy; Cannula, Sinus; Prosthesis, Larynx (Stents And Keels); Button, Nasal Septal; Tube, Tracheal (W/Wo Connector); Tube, Tracheostomy (W/Wo Connector); Splint, Nasal; Prosthesis, Tracheal, Preformed/Molded; Catheters, Suction, Tracheobronchial |
| Ethicon, LLC | Manufacturer | 3 | Suture, Surgical, Absorbable, Polydioxanone; Suture, Nonabsorbable, Synthetic, Polypropylene; Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Ethicon, Inc. | Specification developer (outsources manufacturing) | 3 | Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Nonabsorbable, Synthetic, Polypropylene; Suture, Surgical, Absorbable, Polydioxanone |
| 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 |
| Ray Vision Inc. | Specification developer (outsources manufacturing) | 18 | Retinoscope, Ac-Powered; Ophthalmoscope, Ac-Powered; Perimeter, Automatic, Ac-Powered; System, Imaging, Pulsed Echo, Ultrasonic; Transducer, Ultrasonic, Diagnostic; Prism, Bar, Ophthalmic; Simulatan (Including Crossed Cylinder); Clip, Lens, Trial, Ophthalmic; Perimeter, Manual; Exophthalmometer |
| 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 | Unit, Filter, Membrane; Electrode, Cutaneous; Stimulator, Muscle, Powered, For Muscle Conditioning; Stimulator, Nerve, Transcutaneous, Over-The-Counter; Pack, Hot Or Cold, Reusable; Device, Biofeedback; Interferential Current Therapy; Stimulator, Neuromuscular, External Functional; Stimulator, Muscle, Powered; Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Osteomni Inc | Specification developer (outsources manufacturing) | 5 | Intervertebral Fusion Device With Bone Graft, Cervical; Intervertebral Fusion Device With Bone Graft, Lumbar; Spinal Vertebral Body Replacement Device; Intervertebral Fusion Device With Integrated Fixation, Cervical; Spinal Vertebral Body Replacement Device - Cervical |
| Icp, Inc. | Specification developer (outsources manufacturing) | 5 | Band, Elastic, Orthodontic; Bur, Dental; Mouthpiece, Saliva Ejector; Indicator, Physical/Chemical Sterilization Process; Wrap, Sterilization |
| Fx Shoulder Solutions Inc. | Specification developer (outsources manufacturing) | 4 | Shoulder Prosthesis, Reverse Configuration; Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| 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 | Intervertebral Fusion Device With Bone Graft, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Bone Graft, Cervical; Appliance, Fixation, Spinal Intervertebral Body |
| Medinova Group Co. | Manufacturer | 21 | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear); Pad, Eye; Tape And Bandage, Adhesive; Applicator, Absorbent Tipped, Sterile; Disinfectant, Medical Devices; Container, Specimen Mailer And Storage, Non-Sterile; Dish, Tissue Culture; Punch, Gelfoam, Non-Sterile; Tray, Surgical, Instrument; Adhesive Backed Thermal Skin Patches |
| NanoHive Medical LLC | Manufacturer | 3 | Intervertebral Fusion Device With Bone Graft, Cervical; Intervertebral Fusion Device With Integrated Fixation, Cervical; Mallet |
| 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 |
| Neurofield, Inc. | Specification developer (outsources manufacturing) | 3 | Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety; Normalizing Quantitative Electroencephalograph Software; Stimulator, Auditory, Evoked Response |
| 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 |
| STERIS Corporation | Manufacturer | 1 | Accessories, Cleaning, For Endoscope |
| Medivators Inc | Manufacturer | 1 | Accessories, Cleaning, For Endoscope |
| Aspero Medical, Inc. | Specification developer (outsources manufacturing) | 2 | Endoscopic Access Overtube, Gastroenterology-Urology; Enteroscope And Accessories |
| Normatec Industries, LP | Specification developer (outsources manufacturing) | 2 | Pad, Heating, Powered; Massager, Powered Inflatable Tube |
| 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 |
All DeviceEstablishmentPulse record reports