DeviceEstablishmentPulse: U.S. establishment, page 3 of 4
Records 201 to 350 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 |
|---|---|---|---|
| Labsource, Inc | Specification developer (outsources manufacturing) | 7 | 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 |
| Medtronic Xomed, Inc. | Manufacturer | 1 | Ear, Nose, And Throat Stereotaxic Instrument |
| Serpex Medical, Inc. | Specification developer (outsources manufacturing) | 2 | Unit, Cryosurgical, Accessories |
| Medartis Inc. | Specification developer (outsources manufacturing) | 2 | Prosthesis, Elbow, Hemi-, Radial, Polymer; Plate, Fixation, Bone |
| Inkspace Imaging, Inc | Manufacturer | 1 | Coil, Magnetic Resonance, Specialty |
| Circuit Works Corporation | Manufacturer | 1 | Audiometer |
| Anumana Inc. | Manufacturer | 2 | Cardiac Amyloidosis Machine Learning-Based Notification Software; Pulmonary Hypertension Machine Learning-Based Notification Software |
| Tela Bio, Inc. | Manufacturer | 2 | Mesh, Surgical, Polymeric; Mesh, Surgical |
| Sleepres, Inc | Specification developer (outsources manufacturing) | 1 | Ventilator, Non-Continuous (Respirator) |
| Cactus Bio, LLC | Specification developer (outsources manufacturing) | 1 | Enzyme Linked Immunosorbent Assay, Coccidioides Immitis |
| Church & Dwight Manufacturing Co., Inc. | Manufacturer | 1 | Condom |
| Centinel Spine, LLC | Specification developer (outsources manufacturing) | 2 | Manual Instruments Designed For Use With Total Disc Replacement Devices; Bit, Surgical |
| Balance Ophthalmics, Inc. | Specification developer (outsources manufacturing) | 1 | Applicator, Negative Pressure, External, Ocular |
| GE Healthcare Manufacturing LLC | Manufacturer | 1 | System, Nuclear Magnetic Resonance Imaging |
| Microstructure Imaging, Inc | Specification developer (outsources manufacturing) | 2 | System, Image Processing, Radiological; System, Tomography, Computed, Emission |
| Plus Ev Holdings Inc | Specification developer (outsources manufacturing) | 1 | Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature |
| GE Healthcare Manufacturing LLC | Manufacturer | 1 | System, Nuclear Magnetic Resonance Imaging |
| Providence Medical Technology, Inc. | Manufacturer | 2 | Orthopedic Stereotaxic Instrument; System, Facet Screw Spinal Device |
| Strados Labs Inc. | Specification developer (outsources manufacturing) | 2 | Spirometer, Diagnostic |
| 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 |
| TORNIER Inc. | Specification developer (outsources manufacturing) | 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 |
| Respironics Inc. | Specification developer (outsources manufacturing) | 1 | Ventilator, Non-Continuous (Respirator) |
| Neuralytix LLC | Specification developer (outsources manufacturing) | 2 | Stimulator, Nerve; Neurosurgical Nerve Locator |
| Si-Bone, Inc. | Manufacturer | 2 | Orthopedic Stereotaxic Instrument; Thoracolumbosacral Pedicle Screw System |
| EmCyte Corporation | Specification developer (outsources manufacturing) | 2 | Powered Microneedle Device; Research Use Only/Hematology Devices |
| Cutera, Inc. | Manufacturer | 2 | Electrosurgical, Cutting & Coagulation & Accessories; Powered Laser Surgical Instrument |
| 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 | Screw, Fixation, Bone; Washer, Bolt Nut |
| Kci USA, Inc. | Manufacturer | 1 | Negative Pressure Wound Therapy Powered Suction Pump |
| Global Protection Corp. | Specification developer (outsources manufacturing) | 1 | Lubricant, Personal |
| Kci USA, Inc. | Specification developer (outsources manufacturing) | 1 | Negative Pressure Wound Therapy Powered Suction Pump |
| Performance Health Supply, LLC. | Specification developer (outsources manufacturing) | 3 | Esthesiometer; Discriminator, Two-Point; Orthosis, Corrective Shoe |
| Wandercraft Incorporated | Manufacturer | 1 | Powered Exoskeleton |
| Mozarc Medical Us LLC | Manufacturer | 1 | Needle, Fistula |
| Safe N Simple LLC | Specification developer (outsources manufacturing) | 4 | Dressing, Wound, Drug; Elastomer, Silicone, For Scar Management; Wound Dressing With Animal-Derived Material(S) |
| Supera Fulfillment LLC | Manufacturer | 1 | Blood Specimen Collection Convenience Kit (Excludes Hiv) |
| Ulthera Inc | Specification developer (outsources manufacturing) | 2 | System, Imaging, Pulsed Echo, Ultrasonic; Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption |
| Gt Metabolic Solutions, Inc. | Manufacturer | 2 | Magnetic Compression Anastomosis System; Retractor |
| Imagine Milling Technologies, LLC | Specification developer (outsources manufacturing) | 1 | Abutment, Implant, Dental, Endosseous |
| NuVasive Specialized Orthopedics, Inc. | Manufacturer | 2 | Rod, Fixation, Intramedullary And Accessories; Screw, Fixation, Bone |
| Fenwal, Inc. | Specification developer (outsources manufacturing) | 1 | Separator, Automated, Blood Cell, Diagnostic |
| Surefire Medical, Inc. | Manufacturer | 1 | Catheter, Continuous Flush |
| True Indicating LLC | Manufacturer | 2 | Biological Sterilization Indicator With Indirect Growth Detection; Indicator, Biological Sterilization Process |
| X-Nav Technologies, LLC. | Manufacturer | 2 | Dental Navigation System; Dental Stereotaxic Instrument |
| Sentinel Medical Technologies, LLC | Manufacturer | 2 | Intra-Abdominal Pressure Monitoring Device; Catheter, Retention Type, Balloon |
| Maduro Medical, Inc. | Manufacturer | 1 | Catheter, Thrombus Retriever |
| Life Science Outsourcing, Inc. | Contract sterilizer | 15 | Intervertebral Fusion Device With Bone Graft, Cervical; Intervertebral Fusion Device With Integrated Fixation, Cervical; Appliance, Fixation, Spinal Intervertebral Body; Intervertebral Fusion Device With Bone Graft, Lumbar; Spinal Vertebral Body Replacement Device; Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Machining Midtown LLC | Contract manufacturer | 4 | Pin, Fixation, Smooth; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
| Structure Medical, LLC. | Contract manufacturer | 7 | Appliance, Fixation, Spinal Intervertebral Body; Orthopedic Stereotaxic Instrument; System, Image Processing, Radiological; Tape, Measuring, Rulers And Calipers; Intervertebral Fusion Device With Bone Graft, Lumbar |
| Sterigenics U.S., LLC | Contract sterilizer | 68 | Electrode, Cortical; Powered Laser Surgical Instrument; Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass; Electrode, Depth; Screw, Fixation, Bone; Negative Pressure Wound Therapy Powered Suction Pump; Apparatus, Hemoperfusion, Sorbent; High Intensity Ultrasound System For Prostate Tissue Ablation; Resectoscope; Cystourethroscope |
| Structure Medical, LLC. | Contract manufacturer | 27 | Appliance, Fixation, Spinal Interlaminal; Thoracolumbosacral Pedicle Screw System; Appliance, Fixation, Spinal Intervertebral Body; Posterior Cervical Screw System; Bone Fixation Cerclage, Sublaminar; Intervertebral Fusion Device With Bone Graft, Lumbar; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| Benchmark Electronics, Inc. | Contract manufacturer | 4 | Unit, Operative Dental; Instrument, Ultrasonic Surgical; System, Thermal Regulating; Continuous Measurement Thermometer |
| Summit Orthopedic Technologies Inc. | Contract manufacturer | 3 | Intervertebral Fusion Device With Integrated Fixation, Lumbar; Prosthesis, Intervertebral Disc; Appliance, Fixation, Spinal Intervertebral Body |
| TOMZ Corporation | Contract manufacturer | 36 | Appliance, Fixation, Spinal Interlaminal; Orthosis, Spinal Pedicle Fixation; Orthosis, Spondylolisthesis Spinal Fixation; Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis; Thoracolumbosacral Pedicle Screw System; Intervertebral Fusion Device With Bone Graft, Cervical; Appliance, Fixation, Spinal Intervertebral Body; Posterior Cervical Screw System; Intervertebral Fusion Device With Bone Graft, Thoracic; Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Spectrum Assembly Inc. | Contract manufacturer | 5 | Stimulator, Spinal-Cord, Implanted (Pain Relief); Stimulator, Peripheral Nerve, Implanted (Pain Relief); Interventional Fluoroscopic X-Ray System; System, X-Ray, Fluoroscopic, Image-Intensified; System, Image Processing, Radiological |
| Curiteva, Inc. | Contract manufacturer | 11 | Orthopedic Stereotaxic Instrument; Appliance, Fixation, Spinal Intervertebral Body; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Bone Graft, Lumbar; Intervertebral Fusion Device With Bone Graft, Thoracic; Gauge, Depth; Retractor |
| Engineered Medical Systems, LLC | Contract manufacturer | 29 | Spinal Vertebral Body Replacement Device; Spinal Vertebral Body Replacement Device - Cervical; Orthopedic Stereotaxic Instrument; Appliance, Fixation, Spinal Intervertebral Body; Appliance, Fixation, Spinal Interlaminal; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Bone Graft, Cervical; Intervertebral Fusion Device With Bone Graft, Lumbar; Thoracolumbosacral Pedicle Screw System; Intervertebral Fusion Device With Bone Graft, Thoracic |
| Elite Medical, LLC | Contract manufacturer | 17 | Intervertebral Fusion Device With Bone Graft, Cervical; Intervertebral Fusion Device With Integrated Fixation, Cervical; Appliance, Fixation, Spinal Intervertebral Body; Osteotome, Manual; Mallet; Appliance, Fixation, Spinal Interlaminal; Intervertebral Fusion Device With Bone Graft, Lumbar; Intervertebral Fusion Device With Bone Graft, Thoracic; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Elevator |
| Elite Medical, LLC | Contract manufacturer | 17 | Intervertebral Fusion Device With Bone Graft, Lumbar; Instrument, Cutting, Orthopedic; Curette; Appliance, Fixation, Spinal Interlaminal; Intervertebral Fusion Device With Bone Graft, Cervical; Elevator; Mallet; Intervertebral Fusion Device With Bone Graft, Thoracic; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Nypro Healthcare Baja Inc. (Albuquerque) | Contract manufacturer | 4 | Staple, Implantable; Integrated Operating Table-Electromechanical Surgical System; Stapler, Surgical |
| MINDRAY DS USA, Inc. | Contract manufacturer | 62 | Continuous, Minimal Ventilatory Support, Facility Use Ventilator; Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm); Amplifier And Signal Conditioner, Transducer Signal; System, Network And Communication, Physiological Monitors; Plethysmograph, Impedance; Oximeter; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms); System, Measurement, Blood-Pressure, Non-Invasive; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Burst Suppression Detection Software For Electroencephalograph |
| Sterigenics U.S., LLC | Contract sterilizer | 17 | Apron, Leaded; Catheter, Continuous Flush; Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter; Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation; Catheter, Intracardiac Mapping, High-Density Array; Table, Cystometric, Electric; Catheter, Electrode Recording, Or Probe, Electrode Recording; Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation; Catheter, Ultrasound, Intravascular; Catheter, Percutaneous, Neurovasculature |
| Viant San Antonio, Inc. | Contract manufacturer | 4 | Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief; Drape, Surgical, Exempt; Support, Patient Position; Intraoperative Orthopedic Joint Assessment Aid |
| Ontogen Manufacturing LLC | Contract manufacturer | 5 | Adaptor, Ureteral Catheter; Plethysmograph, Photoelectric, Pneumatic Or Hydraulic; Ballistocardiograph; Electrocardiograph; Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Sterigenics US, LLC | Contract sterilizer | 38 | Injector And Syringe, Angiographic; Injector, Contrast Medium, Automatic; Orthopedic Augmented Reality; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing |
| Symmetry Medical, Inc. - Manchester | Contract manufacturer | 4 | Orthopedic Stereotaxic Instrument; Intervertebral Fusion Device With Bone Graft, Lumbar; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Integrated Operating Table-Electromechanical Surgical System |
| Terumo BCT STERILIZATION SERVICES, Inc. | Contract sterilizer | 6 | Endoscopic Access Overtube, Gastroenterology-Urology; Unit, Cryosurgical, Accessories; Catheter, Embolectomy; Dilator, Vessel, For Percutaneous Catheterization; Syringe, Piston |
| Micropulse Inc | Contract manufacturer | 45 | Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Bone Graft, Lumbar; Intervertebral Fusion Device With Bone Graft, Thoracic; Intervertebral Fusion Device With Bone Graft, Cervical; Appliance, Fixation, Spinal Intervertebral Body; Spinal Vertebral Body Replacement Device - Cervical; Spinal Vertebral Body Replacement Device; Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Arch Medical Solutions - Philadelphia, LLC Dba Jade Precision Medical Components | Contract manufacturer | 20 | Thoracolumbosacral Pedicle Screw System; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; Intervertebral Fusion Device With Bone Graft, Lumbar; Posterior Cervical Screw System; Intervertebral Fusion Device With Bone Graft, Cervical; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Bone Graft, Thoracic; Orthopedic Stereotaxic Instrument |
| Sterigenics US LLC | Contract sterilizer | 58 | Intervertebral Fusion Device With Bone Graft, Lumbar; Thoracolumbosacral Pedicle Screw System; Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer; Dialyzer, High Permeability With Or Without Sealed Dialysate System; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Bone Graft, Cervical; Intervertebral Fusion Device With Integrated Fixation, Cervical; Spinal Vertebral Body Replacement Device; Mallet; Rongeur, Manual |
| Viant AS&O Holdings, LLC | Contract manufacturer | 4 | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Appliance, Fixation, Spinal Intervertebral Body; Appliance, Fixation, Spinal Interlaminal |
| Mackay Manufacturing, Inc. | Contract manufacturer | 11 | Orthopedic Stereotaxic Instrument; Intervertebral Fusion Device With Bone Graft, Cervical; Neurosurgical Nerve Locator; Electrode, Cutaneous; Stimulator, Electrical, Evoked Response; Electromyograph, Diagnostic; Electrode, Needle; Stimulator, Nerve |
| Performance Fibers OEM LLC | Contract manufacturer | 58 | Suture, Nonabsorbable, Synthetic, Polyethylene; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Surgical, Absorbable, Polydioxanone; Suture, Absorbable, Synthetic; Suture, Nonabsorbable, Synthetic, Polyamide; Suture, Nonabsorbable, Synthetic, Polypropylene; Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile; Suture, Absorbable, Natural; Suture, Nonabsorbable, Silk; Fastener, Fixation, Nondegradable, Soft Tissue |
| Hammill Mfg. Co. | Contract manufacturer | 4 | Appliance, Fixation, Spinal Intervertebral Body; Thoracolumbosacral Pedicle Screw System; Posterior Cervical Screw System; Appliance, Fixation, Spinal Interlaminal |
| Rms Co. | Contract manufacturer | 9 | Intervertebral Fusion Device With Bone Graft, Lumbar; Intervertebral Fusion Device With Bone Graft, Thoracic; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Bone Graft, Cervical; Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Sterigenics U.S., LLC | Contract sterilizer | 7 | Integrated Continuous Glucose Monitoring System, Factory Calibrated; Tape And Bandage, Adhesive; Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter; Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter; Introducer, Catheter |
| Sterigenics US LLC | Contract sterilizer | 15 | 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; Catheter, Ureteral, Gastro-Urology; Powered Laser Surgical Instrument; Accessories, Blood Circuit, Hemodialysis; Set, Tubing, Blood, With And Without Anti-Regurgitation Valve; Subsystem, Water Purification; Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Donson Machine Company | Contract manufacturer | 13 | Wrench; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Spinal Vertebral Body Replacement Device - Cervical; Spinal Vertebral Body Replacement Device; System, Image Processing, Radiological; Orthopedic Stereotaxic Instrument; Intervertebral Fusion Device With Bone Graft, Lumbar; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
| Pioneer Surgical Technology, Inc. | Contract manufacturer | 9 | Cerclage, Fixation; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Screw, Fixation, Bone; Washer, Bolt Nut; Plate, Fixation, Bone; Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Dot America, Inc. | Contract manufacturer | 5 | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Turner Medical Inc. | Contract manufacturer | 9 | Plate, Fixation, Bone; Template; Screw, Fixation, Bone; Forceps; Orthopedic Stereotaxic Instrument |
| Moebius Precision Corp | Contract manufacturer | 4 | Fastener, Fixation, Nondegradable, Soft Tissue; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
| Spartronics Watertown LLC | Contract manufacturer | 6 | Stimulator, Spinal-Cord, Totally Implanted For Pain Relief; Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy; Stimulator, Electrical, Implanted, For Essential Tremor; Stimulator, Electrical, Implanted, For Parkinsonian Tremor; Stimulator, Electrical, Implanted, For Parkinsonian Symptoms; Needle, Hypodermic, Single Lumen |
| Midwest Sterilization Corp. | Contract sterilizer | 13 | Catheter, Percutaneous; Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation; Aortic Valve, Prosthesis, Percutaneously Delivered; System, Appendage Closure, Left Atrial; Prosthesis, Mitral Valve, Percutaneously Delivered; Catheter, Ultrasound, Intravascular |
| Midwest Sterilization Corp. | Contract sterilizer | 20 | Stimulator, Spinal-Cord, Implanted (Pain Relief); Aortic Valve, Prosthesis, Percutaneously Delivered; Catheter, Ultrasound, Intravascular; Electrode, Spinal Epidural; Catheter, Percutaneous; Prosthesis, Mitral Valve, Percutaneously Delivered; Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation; Cover, Burr Hole; System, Appendage Closure, Left Atrial |
| Sterigenics U.S., LLC | Contract sterilizer | 51 | System, Ablation, Microwave And Accessories; Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented); Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Elbow, Semi-Constrained, Cemented; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; System, Appendage Closure, Left Atrial; Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer; Catheter, Percutaneous; Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained |
| Aps Materials, Inc. | Contract manufacturer | 12 | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
| Kimball Solutions Jasper, Inc. | Contract manufacturer | 9 | Interventional Fluoroscopic X-Ray System; Cable, Transducer And Electrode, Patient, (Including Connector); Computer, Blood-Pressure; System, Imaging, Pulsed Echo, Ultrasonic; Stand, Infusion; Nasopharyngoscope (Flexible Or Rigid); Endoscope, Neurological; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece |
| Mlife Diagnostics LLC | Contract manufacturer | 11 | Test, Methamphetamine, Over The Counter; Test, Cannabinoid, Over The Counter; Test, Amphetamine, Over The Counter; Test, Tricyclic Antidepressants, Over The Counter; Test, Phencyclidine (Pcp), Over The Counter; Test, Opiates, Over The Counter; Test, Cocaine And Cocaine Metabolites, Over The Counter; Test, Methadone, Over The Counter; Test, Propoxyphene, Over The Counter; Test, Barbiturate, Over The Counter |
| COLLAGEN SOLUTIONS/TISSX LLC d/b/a Evergen | Contract manufacturer | 3 | Bone Grafting Material, Animal Source; Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon; Mesh, Surgical |
| Merits Health Products, Inc. | Contract manufacturer | 18 | Wheelchair, Powered; Components, Wheelchair; Vehicle, Motorized 3-Wheeled; Powered Stairway Chair Lift; Cushion, Wheelchair; Accessories, Wheelchair |
| Hm Product Solutions, Ltd. | Contract manufacturer | 3 | System, X-Ray, Tomography, Computed; Full Field Digital, System, X-Ray, Mammographic |
| Tecan Cdmo Solutions Mh, Corp. | Contract manufacturer | 3 | Deformability Cytometry For Sepsis Risk Assessment |
| Sterigenics US LLC | Contract sterilizer | 16 | Rod, Fixation, Intramedullary And Accessories; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Knife, Surgical; Arthroscope; Staple, Fixation, Bone; Nail, Fixation, Bone; Screw, Fixation, Bone; Orthopedic Stereotaxic Instrument; Sacroiliac Joint Fixation; Injector And Syringe, Angiographic |
| Sterigenics US LLC | Contract sterilizer | 19 | Lipoaspirate Washing System For Aesthetic Body Contouring; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; System, Suction, Lipoplasty; Saline, Vascular Access Flush; Powered Microneedle Device; Adaptor, Holder, Syringe |
| Mfg One, LLC | Contract manufacturer | 6 | Warmer, Thermal, Infusion Fluid; Set, Administration, Intravascular; Pump, Infusion |
| Sterigenics Radiation Technologies, LLC | Contract sterilizer | 6 | Glucose Range Monitoring System; Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery; Mesh, Surgical; Collagen Surgical Mesh Containing Drugs; Scaffold, Infrapopliteal, Absorbable; Alternate Controller Enabled Insulin Infusion Pump |
| Siemens Medical Solutions USA, Inc. | Contract manufacturer | 5 | Automated Radiological Image Processing Software; System, X-Ray, Tomography, Computed; System, Tomography, Computed, Emission; Full Field Digital, System, X-Ray, Mammographic; Digital Breast Tomosynthesis |
| Sterigenics U.S., LLC | Contract sterilizer | 7 | Injector And Syringe, Angiographic; Abutment, Implant, Dental, Endosseous; Set, I.V. Fluid Transfer; Negative Pressure Wound Therapy Powered Suction Pump; Mesh, Surgical, Polymeric; Wire, Guide, Catheter; Alternate Controller Enabled Insulin Infusion Pump |
| Linemaster Switch Corp. | Contract manufacturer | 7 | System, Surgical, Computer Controlled Instrument; Electrosurgical, Cutting & Coagulation & Accessories; Endoscope, Neurological; Nasopharyngoscope (Flexible Or Rigid); Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece |
| Medin Technologies, Inc. | Contract manufacturer | 20 | Screw, Fixation, Bone; Plate, Fixation, Bone; Washer, Bolt Nut; Staple, Fixation, Bone |
| Sterigenics U.S., LLC | Contract sterilizer | 7 | Intervertebral Fusion Device With Bone Graft, Lumbar; Appliance, Fixation, Spinal Intervertebral Body; Powered Laser Surgical Instrument |
| Guardian Medical USA, Inc | Contract manufacturer | 4 | Intervertebral Fusion Device With Bone Graft, Lumbar; Sacroiliac Joint Fixation; Appliance, Fixation, Spinal Interlaminal; Posterior Cervical Screw System |
| Proguard Health Inc. | Contract manufacturer | 5 | Handpiece, Air-Powered, Dental; Handpiece, Contra- And Right-Angle Attachment, Dental; Activator, Ultraviolet, For Polymerization; Cup, Prophylaxis |
| Stryker Puerto Rico, LLC. | Contract manufacturer | 4 | Nasopharyngoscope (Flexible Or Rigid); Endoscope, Neurological; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece |
| J Sterling Industries LLC | Contract manufacturer | 4 | Holder, Needle; Orthopedic; Component, Cast; Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene; Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Trelleborg Sealing Solutions Us, Inc. | Contract manufacturer | 3 | Implant, Eye Valve; Splint, Intranasal Septal; Implantable Cardioverter Defibrillator (Non-Crt) |
| LivaNova USA, INC. | Contract manufacturer | 5 | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass; Dilator, Vessel, For Percutaneous Catheterization |
| Aurora Gp Lab Inc | Contract manufacturer | 6 | Lens, Contact, Orthokeratology, Overnight; Lens, Contact (Other Material) - Daily; Lens, Contact (Orthokeratology) |
| Praxis Powder Technology, Inc. | Contract manufacturer | 5 | Cerclage, Fixation; Washer, Bolt Nut; Fastener, Fixation, Nondegradable, Soft Tissue; Subcutaneous Implanted Apheresis Port |
| MEDLINE INDUSTRIES, LP (Northpoint Services) | Contract sterilizer | 11 | Enteral Syringes With Enteral Specific Connectors; Tourniquet, Pneumatic; Clip, Implantable; Clip, Vascular; Syringe, Piston; Monitor, Pressure, Intracompartmental; Set, Administration, Intravascular; Tubes, Gastrointestinal (And Accessories) |
| Sterigenics U.S., LLC | Contract sterilizer | 10 | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer; Prosthesis, Toe, Constrained, Polymer; Fastener, Fixation, Nondegradable, Soft Tissue; Arthroscope |
| Sterigenics U.S., LLC | Contract sterilizer | 15 | Radioimmunoassay, Thyroid-Stimulating Hormone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Cutaneous Tissue Adhesive With Mesh; Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed; System, Cement Removal Extraction; Arthroscope; Burr, Orthopedic; Mesh, Surgical, Polymeric; Screw, Fixation, Bone |
| Sterigenics US LLC | Contract sterilizer | 4 | Insufflator, Laparoscopic; Laparoscope, General & Plastic Surgery |
| Sterigenics Radiation Technologies IN, Inc | Contract sterilizer | 3 | Sacroiliac Joint Fixation; Screw, Fixation, Bone; Appliance, Fixation, Spinal Intervertebral Body |
| Packaging Compliance Medical, LLC | Contract manufacturer | 10 | Guide, Surgical, Instrument; Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment; Plate, Fixation, Bone; Driver, Surgical, Pin; Punch, Surgical; Bit, Surgical; Extractor; Hammer, Surgical; Bit, Drill; Reamer |
| Arcamed, LLC | Contract manufacturer | 5 | Screw, Fixation, Bone; Washer, Bolt Nut; Staple, Fixation, Bone |
| ZimVie US Corp LLC | Contract manufacturer | 5 | Abutment, Implant, Dental, Endosseous |
| Sterigenics U.S. LLC | Contract sterilizer | 6 | System, Facet Screw Spinal Device; Orthopedic Stereotaxic Instrument; Magnetic Surgical System; Trabeculotome; Pump, Infusion, Ophthalmic |
| Steris Isomedix Puerto Rico, Inc. | Contract sterilizer | 3 | Thoracolumbosacral Pedicle Screw System; Appliance, Fixation, Spinal Intervertebral Body; Appliance, Fixation, Spinal Interlaminal |
| Metier Medical (USA) LLC | Other | 7 | Needle, Aspiration And Injection, Disposable; Syringe, Piston; Syringe, Antistick; Needle, Hypodermic, Single Lumen |
| Maestro Logistics, LLC | Contract manufacturer | 2 | Washer, Bolt Nut; Screw, Fixation, Bone |
| Lumiquick Diagnostics, Inc. | Contract manufacturer | 1 | Enzyme Linked Immunosorbent Assay, Coccidioides Immitis |
| D & R Products Co., Inc. | Contract manufacturer | 1 | Arthroscope |
| Pacific Instruments Inc. | Contract manufacturer | 2 | Sacroiliac Joint Fixation; Orthopedic Stereotaxic Instrument |
| VIVE Health LLC | Repackager or relabeler | 10 | Wheelchair, Powered; Vehicle, Motorized 3-Wheeled; Dressing, Wound, Drug; Chair, Geriatric; Binder, Breast; Exerciser, Non-Measuring; Wound Dressing With Animal-Derived Material(S); Pump, Breast, Powered; Tubing, Pressure And Accessories |
| Isomedix Operations Inc | Contract sterilizer | 1 | Introducer, Catheter |
| Fruh Packaging Inc. | Contract manufacturer | 2 | Plate, Fixation, Bone; Screw, Fixation, Bone |
| Cgbio USA, Inc. | Repackager or relabeler | 47 | Orthosis, Spinal Pedicle Fixation; Orthosis, Spondylolisthesis Spinal Fixation; Reamer; Appliance, Fixation, Spinal Interlaminal; Thoracolumbosacral Pedicle Screw System; Plate, Cranioplasty, Preformed, Non-Alterable; Rod, Fixation, Intramedullary And Accessories; Posterior Cervical Screw System; Intervertebral Fusion Device With Bone Graft, Cervical; Intervertebral Fusion Device With Bone Graft, Lumbar |
| Cardinal Health 200, LLC | Other | 8 | Fentanyl And Other Opioid Protection Glove; Polymer Patient Examination Glove; Medical Glove, Specialty; Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs; Dressing, Wound, Drug; Depressor, Tongue, Non-Surgical; Catheter, Retention Type, Balloon; Gown, Surgical |
| Oketz Logistics LLC | Repackager or relabeler | 56 | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Scaler, Ultrasonic; Material, Tooth Shade, Resin; Handpiece, Air-Powered, Dental; Mask, Surgical; Agent, Tooth Bonding, Resin; Airbrush; Activator, Ultraviolet, For Polymerization; Material, Impression; Cord, Retraction |
| Advance-Esthetic LLC | Other | 8 | Electrosurgical, Cutting & Coagulation & Accessories; Over-The-Counter Powered Light Based Laser For Acne; Light Based Over The Counter Wrinkle Reduction; Lamp, Infrared, Therapeutic Heating; Powered Light Based Non-Laser Surgical Instrument With Thermal Effect; Powered Laser Surgical Instrument |
| Acertara Acoustic Laboratories, LLC | Contract manufacturer | 2 | Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Echo, Ultrasonic |
| Maxim Biomedical Inc. | Contract manufacturer | 2 | Visual, Pregnancy Hcg, Prescription Use; Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users |
| Titanlinks Logistics LLC | Repackager or relabeler | 336 | Scaler, Ultrasonic; Material, Tooth Shade, Resin; Varnish, Cavity; Sealant, Pit And Fissure, And Conditioner; Medical Glove, Specialty; Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs; Polymer Patient Examination Glove; Fentanyl And Other Opioid Protection Glove; Cement, Dental; Coating, Filling Material, Resin |
| Cosco International, Inc. | Contract manufacturer | 1 | Lubricant, Personal |
| Isomedix Operations Inc | Contract sterilizer | 1 | Injector, Contrast Medium, Automatic |
| Jmu Dental, Inc | Repackager or relabeler | 31 | Agent, Tooth Bonding, Resin; Tray, Surgical, Ent; Syringe, Irrigating (Dental); Scaler, Periodontic; Apron, Leaded; Dental Barriers And Sleeves; Tape, Measuring, Rulers And Calipers; Indicator, Physical/Chemical Sterilization Process; Paper, Articulation; Instrument, Manual, Surgical, General Use |
| Tpc Advanced Technology, Inc. | Repackager or relabeler | 4 | Scanner, Color; Portable Dental Operative Unit; Chair, Dental, With Operative Unit; Unit, Operative Dental |
| Karl Storz Endoscopy-America, Inc. | Other | 15 | Endoscopic Grasping/Cutting Instrument, Non-Powered; Arthroscope; Laparoscope, General & Plastic Surgery; Hysteroscope (And Accessories); Laryngoscope, Nasopharyngoscope; Insufflator, Endoscopic Vessel Harvesting; Insufflator, Laparoscopic; Pump, Portable, Aspiration (Manual Or Powered); Nasopharyngoscope (Flexible Or Rigid); System, Irrigation, Urological |
| Karl Storz Endoscopy-America, Inc. | Repackager or relabeler | 14 | Hysteroscope (And Accessories); Insufflator, Endoscopic Vessel Harvesting; Insufflator, Laparoscopic; Endoscopic Grasping/Cutting Instrument, Non-Powered; Laparoscope, General & Plastic Surgery; Pump, Portable, Aspiration (Manual Or Powered); Nasopharyngoscope (Flexible Or Rigid); System, Irrigation, Urological; Insufflator, Hysteroscopic; Arthroscope |
| Bard Peripheral Vascular, Inc. | Contract manufacturer | 2 | Shunt, Portosystemic, Endoprosthesis; Instrument, Biopsy |
| Premium Plus Dental Supplies Inc | Other | 12 | Material, Impression; Mask, Surgical; Agent, Absorbable Hemostatic, Non-Collagen Based; Syringe, Piston; Tubes, Vials, Systems, Serum Separators, Blood Collection; Needle, Hypodermic, Single Lumen; Cleaner, Ultrasonic, Medical Instrument; Cement, Dental |
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