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- Page 2

# DeviceEstablishmentPulse: records in California, page 2 of 3

Records 51 to 200 of the 310 newest listed for this hub. Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration).

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| Record | Role | New listings | Devices |
|---|---|---|---|
| Edwards Lifesciences LLC | Specification developer (outsources manufacturing) | 2 | Heart-Valve, Polymeric; Left Atrial Appendage Clip, Implantable |
| Beta Bionics, Inc. | Manufacturer | 2 | Continuous Glucose Monitor Retrospective Data Analysis Software; Alternate Controller Enabled Insulin Infusion Pump |
| Optik K & R Inc. | Contract manufacturer | 18 | Lens, Contact (Other Material) - Daily; Lens, Contact (Polymethylmethacrylate); Lens, Contact (Rigid Gas Permeable), Extended Wear; Lens, Contact, Orthokeratology, Overnight; Lens, Contact (Orthokeratology) |
| MicroVention, Inc. | Manufacturer | 2 | Aspiration Thrombectomy Catheter; Catheter, Continuous Flush |
| Subtle Medical Inc | Manufacturer | 2 | Automated Radiological Image Processing Software; System, Image Processing, Radiological |
| Penumbra Inc. | Manufacturer | 2 | Catheter, Thrombus Retriever; Peripheral Mechanical Thrombectomy With Aspiration |
| Penumbra Inc. | Manufacturer | 2 | Peripheral Mechanical Thrombectomy With Aspiration; Catheter, Thrombus Retriever |
| Penumbra, Inc. | Manufacturer | 2 | Peripheral Mechanical Thrombectomy With Aspiration; Catheter, Thrombus Retriever |
| 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 |
| Serpex Medical, Inc. | Specification developer (outsources manufacturing) | 2 | Unit, Cryosurgical, Accessories |
| Inkspace Imaging, Inc | Manufacturer | 1 | Coil, Magnetic Resonance, Specialty |
| Sleepres, Inc | Specification developer (outsources manufacturing) | 1 | Ventilator, Non-Continuous (Respirator) |
| Providence Medical Technology, Inc. | Manufacturer | 2 | System, Facet Screw Spinal Device; Orthopedic Stereotaxic Instrument |
| Life Technologies Corporation | Manufacturer | 1 | Assay, Genotype, Hiv Drug Resistance, In Vitro |
| Canadian Hospital Specialties Ltd. | Contract manufacturer | 12 | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days; Anesthesia Conduction Kit; Introducer, Catheter; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Spinal Epidural Anesthesia Kit; Introducer, Syringe Needle; Needle, Conduction, Anesthetic (W/Wo Introducer); Stimulator, Nerve; Spinal Anesthesia Kit |
| Si-Bone, Inc. | Manufacturer | 2 | Thoracolumbosacral Pedicle Screw System; Orthopedic Stereotaxic Instrument |
| Carlsmed, Inc. | Manufacturer | 2 | Appliance, Fixation, Spinal Intervertebral Body |
| Cutera, Inc. | Manufacturer | 2 | Powered Laser Surgical Instrument; Electrosurgical, Cutting & Coagulation & Accessories |
| Life Science Outsourcing, Inc. | Contract sterilizer | 15 | Intervertebral Fusion Device With Integrated Fixation, Cervical; Intervertebral Fusion Device With Bone Graft, Cervical; Intervertebral Fusion Device With Bone Graft, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Appliance, Fixation, Spinal Intervertebral Body; Spinal Vertebral Body Replacement Device |
| Spectrum Assembly Inc. | Contract manufacturer | 5 | Stimulator, Peripheral Nerve, Implanted (Pain Relief); Stimulator, Spinal-Cord, Implanted (Pain Relief); Interventional Fluoroscopic X-Ray System; System, Image Processing, Radiological; System, X-Ray, Fluoroscopic, Image-Intensified |
| Sterigenics U.S., LLC | Contract sterilizer | 7 | Introducer, Catheter; 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 |
| Tecan Cdmo Solutions Mh, Corp. | Contract manufacturer | 3 | Deformability Cytometry For Sepsis Risk Assessment |
| Sterigenics Radiation Technologies, LLC | Contract sterilizer | 6 | Alternate Controller Enabled Insulin Infusion Pump; Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery; Mesh, Surgical; Collagen Surgical Mesh Containing Drugs; Glucose Range Monitoring System; Scaffold, Infrapopliteal, Absorbable |
| Sterigenics U.S., LLC | Contract sterilizer | 7 | Abutment, Implant, Dental, Endosseous; Negative Pressure Wound Therapy Powered Suction Pump; Wire, Guide, Catheter; Alternate Controller Enabled Insulin Infusion Pump; Mesh, Surgical, Polymeric; Set, I.V. Fluid Transfer; Injector And Syringe, Angiographic |
| Proguard Health Inc. | Contract manufacturer | 5 | Handpiece, Air-Powered, Dental; Activator, Ultraviolet, For Polymerization; Cup, Prophylaxis; Handpiece, Contra- And Right-Angle Attachment, Dental |
| Trelleborg Sealing Solutions Us, Inc. | Contract manufacturer | 3 | Splint, Intranasal Septal; Implant, Eye Valve; Implantable Cardioverter Defibrillator (Non-Crt) |
| Sterigenics U.S. LLC | Contract sterilizer | 6 | System, Facet Screw Spinal Device; Orthopedic Stereotaxic Instrument; Magnetic Surgical System; Trabeculotome; Pump, Infusion, Ophthalmic |
| Gurin Products LLC | Repackager or relabeler | 3 | Electrode, Cutaneous; Stimulator, Nerve, Transcutaneous, Over-The-Counter; Stimulator, Muscle, Powered, For Muscle Conditioning |
| Benev Company Inc | Other | 5 | Electrosurgical, Cutting & Coagulation & Accessories; Powered Microneedle Device; Powered Laser Surgical Instrument; Lamp, Infrared, Therapeutic Heating |
| Karl Storz Endoscopy-America, Inc. | Other | 17 | Hysteroscope (And Accessories); Endoscope, Neurological; Coagulator-Cutter, Endoscopic, Unipolar (And Accessories); Laryngoscope, Nasopharyngoscope; System, Irrigation, Urological; Nasopharyngoscope (Flexible Or Rigid); Pump, Portable, Aspiration (Manual Or Powered); Insufflator, Hysteroscopic; Arthroscope; Endoscopic Irrigation/Suction System |
| Lumiquick Diagnostics, Inc. | Contract manufacturer | 1 | Enzyme Linked Immunosorbent Assay, Coccidioides Immitis |
| Cgbio USA, Inc. | Repackager or relabeler | 47 | Plate, Cranioplasty, Preformed, Non-Alterable; Rod, Fixation, Intramedullary And Accessories; Appliance, Fixation, Spinal Interlaminal; Posterior Cervical Screw System; Appliance, Fixation, Spinal Intervertebral Body; Intervertebral Fusion Device With Integrated Fixation, Cervical; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; System, Facet Screw Spinal Device; Thoracolumbosacral Pedicle Screw System |
| Jmu Dental, Inc | Repackager or relabeler | 30 | Tray, Surgical, Ent; Dental Barriers And Sleeves; Apron, Leaded; Agent, Tooth Bonding, Resin; Bedding, Disposable, Medical; Material, Tooth Shade, Resin; Scaler, Periodontic; Indicator, Physical/Chemical Sterilization Process; Depressor, Tongue, Non-Surgical; Parallelometer |
| 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 |
| Tpc Advanced Technology, Inc. | Repackager or relabeler | 4 | Scanner, Color; Portable Dental Operative Unit; Chair, Dental, With Operative Unit; Unit, Operative Dental |
| Alom Technologies Corporation | Contract manufacturer | 2 | Dna Specimen Collection, Saliva; Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Traferox Technologies Inc. | Manufacturer | 3 | Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs; System, Perfusion, Kidney; System And Accessories, Isolated Heart, Transport And Preservation |
| Conavi Medical Inc | Specification developer (outsources manufacturing) | 3 | System, Imaging, Optical Coherence Tomography (Oct); System, Imaging, Pulsed Echo, Ultrasonic; Catheter, Ultrasound, Intravascular |
| Vitaa Medical Solutions Inc | Manufacturer | 1 | Automated Radiological Image Processing Software |
| AMD Medicom Inc. | Specification developer (outsources manufacturing) | 9 | Polymer Patient Examination Glove; Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs; Medical Glove, Specialty; Fentanyl And Other Opioid Protection Glove; Powder-Free Polychloroprene Patient Examination Glove |
| Maduro Medical, Inc. | Manufacturer | 1 | Catheter, Thrombus Retriever |
| Medalliance, LLC | Manufacturer | 1 | Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter |
| Paragon Implant Mfg., LLC | Manufacturer | 2 | Abutment, Implant, Dental, Endosseous; Implant, Endosseous, Root-Form |
| Isomedix Operations Inc. | Manufacturer | 1 | Device, Monitoring, Intracranial Pressure |
| Axora Medical, Inc. | Specification developer (outsources manufacturing) | 1 | Hysteroscope (And Accessories) |
| Innovacyn, Inc. | Manufacturer | 2 | Dressing, Wound, Drug; Lavage, Jet |
| Ark Diagnostics Inc | Manufacturer | 2 | Enzyme Immunoassay, Benzodiazepine; Anti-Factor Xa Activity Test System, Apixaban |
| Emboline Inc | Manufacturer | 1 | Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures |
| Prismatik Dentalcraft, Inc. | Manufacturer | 2 | Powder, Porcelain; Resin, Denture, Relining, Repairing, Rebasing |
| Shockwave Medical, Inc. | Manufacturer | 1 | Percutaneous Catheter, Ultrasound |
| Bolt Medical Inc. | Manufacturer | 1 | Percutaneous Catheter, Ultrasound |
| Imperative Care Inc. | Manufacturer | 1 | Catheter, Percutaneous, Neurovasculature |
| Reflow Medical, Inc | Manufacturer | 1 | Catheter For Crossing Total Occlusions |
| Auris Health, Inc. | Manufacturer | 2 | System, X-Ray, Tomography, Computed; Bronchoscope (Flexible Or Rigid) |
| SW Technologies Inc. | Manufacturer | 4 | Polymer Patient Examination Glove; Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs; Fentanyl And Other Opioid Protection Glove; Medical Glove, Specialty |
| Synova Life Sciences, Inc. | Manufacturer | 1 | Lipoaspirate Washing System For Aesthetic Body Contouring |
| Gravitas Medical, Inc. | Manufacturer | 2 | Tubes, Gastrointestinal (And Accessories); Tube, Feeding |
| Alcon Research, LLC | Manufacturer | 2 | Drape, Surgical, Exempt; Laser, Ophthalmic |
| Alcon Research, LLC | Specification developer (outsources manufacturing) | 2 | Laser, Ophthalmic; Drape, Surgical, Exempt |
| Pac-Dent Inc. | Manufacturer | 2 | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations; Cement, Dental |
| One Lambda, Inc. | Manufacturer | 1 | Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test |
| Diazyme Laboratories, Inc. | Manufacturer | 1 | Lipoprotein, Low-Density, Antigen, Antiserum, Control |
| Nobel Biocare USA, LLC | Manufacturer | 2 | Dental Abutment Design Software For Dental Laboratory; Abutment, Implant, Dental, Endosseous |
| Carbon, Inc. | Specification developer (outsources manufacturing) | 1 | Resin, Denture, Relining, Repairing, Rebasing |
| ARCH Medical Solutions - Escondido LLC | Manufacturer | 1 | Appliance, Fixation, Spinal Intervertebral Body |
| Applied Lacquer Industries, Inc. | Manufacturer | 1 | Lamp, Infrared, Therapeutic Heating |
| Led Intellectual Properties LLC | Manufacturer | 2 | Light Based Over The Counter Wrinkle Reduction; Over-The-Counter Powered Light Based Laser For Acne |
| Curemetrix, Inc. | Manufacturer | 1 | Automated Radiological Image Processing Software |
| Applied Medical Resources Corp. | Manufacturer | 2 | Ring (Wound Protector), Drape Retention, Internal; Illuminator, Non-Remote |
| Archy Dental, Inc. | Manufacturer | 1 | System, Image Processing, Radiological |
| Spirair, Inc | Specification developer (outsources manufacturing) | 1 | Polymer, Ear, Nose And Throat, Synthetic, Absorbable |
| Affirm Medical Technologies II, LLC | Specification developer (outsources manufacturing) | 1 | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
| Candelis, Inc. | Manufacturer | 1 | System, Image Processing, Radiological |
| Amaze Neuro, Inc. | Specification developer (outsources manufacturing) | 1 | Device, Biofeedback |
| Quest Diagnostics Nichols Institute | Manufacturer | 1 | Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors |
| Nucare LLC | Specification developer (outsources manufacturing) | 3 | Finger Cot; Latex Patient Examination Glove |
| Micro Therapeutics, Inc. Dba Ev3 Neurovascular | Manufacturer | 2 | Catheter, Thrombus Retriever; Device, Vascular, For Promoting Embolization |
| Eko Health, Inc. | Specification developer (outsources manufacturing) | 1 | Stethoscope, Electronic |
| Spine Innovation, LLC | Specification developer (outsources manufacturing) | 1 | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Engineering Cpr Inc. | Contract manufacturer | 11 | Orthopedic Stereotaxic Instrument; Neurological Stereotaxic Instrument |
| Spiro Robotics Inc. | Specification developer (outsources manufacturing) | 1 | Tube, Tracheal (W/Wo Connector) |
| Intuitive Surgical, Inc. | Manufacturer | 1 | Laparoscope, General & Plastic Surgery |
| Promaxo, LLC | Specification developer (outsources manufacturing) | 2 | System, Nuclear Magnetic Resonance Imaging; Coil, Magnetic Resonance, Specialty |
| Empirical Spine, Inc. | Manufacturer | 2 | Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| OptraSCAN Inc. | Manufacturer | 1 | Microscope, Automated, Image Analysis, Operator Intervention |
| Cytovale, Inc. | Manufacturer | 1 | Deformability Cytometry For Sepsis Risk Assessment |
| Infinity Neuro, LLC | Manufacturer | 1 | Catheter, Percutaneous |
| DiaSorin Molecular LLC | Manufacturer | 2 | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System; Real Time Nucleic Acid Amplification System |
| Edwards Lifesciences LLC | Specification developer (outsources manufacturing) | 1 | Left Atrial Appendage Clip, Implantable |
| Sterigenics Radiation Technologies Canada, Inc | Contract sterilizer | 7 | Wound Dressing With Animal-Derived Material(S); Table, Operating-Room, Electrical; Catheter, Ultrasound, Intravascular; System, Imaging, Optical Coherence Tomography (Oct); System, Imaging, Pulsed Echo, Ultrasonic; Bandage, Liquid |
| Merchsource LLC | Specification developer (outsources manufacturing) | 1 | Pad, Heating, Powered |
| Intuitive Surgical, Inc. | Manufacturer | 1 | Insufflator, Laparoscopic |
| PULMONX, Corp. | Manufacturer | 1 | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) |
| Sonorous NV, Inc. | Specification developer (outsources manufacturing) | 2 | Catheter, Percutaneous; Catheter, Percutaneous, Neurovasculature |
| Outset Medical, Inc. | Specification developer (outsources manufacturing) | 2 | Dialyzer, High Permeability With Or Without Sealed Dialysate System; Subsystem, Water Purification |
| Transtimulation Research Inc | Manufacturer | 1 | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Acclarent, Inc. | Specification developer (outsources manufacturing) | 1 | Eustachian Tube Balloon Dilation Device |
| Penumbra Inc. | Manufacturer | 1 | Catheter, Thrombus Retriever |
| Bear Down Brands, LLC | Specification developer (outsources manufacturing) | 1 | Clinical Electronic Thermometer |
| Penumbra Inc. | Manufacturer | 1 | Catheter, Thrombus Retriever |
| Penumbra, Inc. | Manufacturer | 1 | Catheter, Thrombus Retriever |
| Becton, Dickinson And Company | Specification developer (outsources manufacturing) | 1 | Clamp, Vascular |
| Prowess, Inc. | Manufacturer | 1 | System, Planning, Radiation Therapy Treatment |
| Exelint International, Co. | Manufacturer | 1 | Needle, Hypodermic, Single Lumen |
| Fziomed, Inc. | Manufacturer | 1 | Absorbable Gel For Intraoperative Use In Spine Surgery |
| Bio-Rad Laboratories, Inc. | Manufacturer | 1 | Droplet Digital Pcr System |
| Aerin Medical Inc. | Specification developer (outsources manufacturing) | 1 | Electrosurgical, Cutting & Coagulation & Accessories |
| Natera Inc. | Manufacturer | 1 | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| Expanse Medical Inc. | Manufacturer | 2 | Aspiration Thrombectomy Catheter; Catheter, Continuous Flush |
| Sprintray Inc. | Manufacturer | 2 | Material, Tooth Shade, Resin; Denture, Plastic, Teeth |
| Sprintray Inc. | Specification developer (outsources manufacturing) | 2 | Material, Tooth Shade, Resin; Denture, Plastic, Teeth |
| GUARDANT HEALTH, INC (Campus) | Manufacturer | 1 | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| Alife Health, Inc. | Manufacturer | 1 | Embryo Image Assessment System, Assisted Reproduction |
| Acuvu Medical System Inc, | Specification developer (outsources manufacturing) | 1 | Hysteroscope (And Accessories) |
| Vizaramed, Inc. | Specification developer (outsources manufacturing) | 1 | Introducer, Catheter |
| Vektor Medical, Inc. | Manufacturer | 1 | Computer, Diagnostic, Programmable |
| Q'apel Medical, Inc. | Manufacturer | 1 | Catheter, Thrombus Retriever |
| Visionary Contact Lens, Inc. | Manufacturer | 1 | Lens, Contact, Orthokeratology, Overnight |
| Uroviu Corporation | Specification developer (outsources manufacturing) | 2 | Cystoscope And Accessories, Flexible/Rigid |
| Innopex Limited | Foreign exporter | 89 | Bag, Urine Collection, Leg, For External Use, Sterile; Esthesiometer; Mattress, Flotation Therapy, Non-Powered; Catheter, Urological; Adaptor, Hygiene; Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs; Polymer Patient Examination Glove; Syringe, Piston; Catheter, Irrigation; Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Imperial Optical, Inc | Foreign exporter | 3 | Lenses, Soft Contact, Extended Wear; Lens, Contact, (Disposable); Lenses, Soft Contact, Daily Wear |
| Citest Diagnostics Inc. | Repackager or relabeler | 80 | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant); Test, Urine Leukocyte; Thin Layer Chromatography, Morphine; Thin Layer Chromatography, Methamphetamine; Test, Methadone, Over The Counter; Enzyme Immunoassay, Methadone; Radioimmunoassay, Tricyclic Antidepressant Drugs; Enzyme Immunoassay, Amphetamine; Enzyme Immunoassay, Benzodiazepine; Enzyme Immunoassay, Opiates |
| 15445361 Canada Inc. | Foreign exporter | 26 | System, Thermal Regulating; Container, Liquid Medication, Graduated; Lubricant, Patient; Catheter, Retention Type, Balloon; Stethoscope, Manual; Set, Administration, Intravascular; Tubes, Vials, Systems, Serum Separators, Blood Collection; Tubing, Noninvasive; Latex Patient Examination Glove; Cannula, Surgical, General & Plastic Surgery |
| Borvo Medical, Inc. | Specification developer (outsources manufacturing) | 1 | Clamp, Surgical, General & Plastic Surgery |
| Kash Sales Inc. | Foreign exporter | 8 | Cement, Dental; Needle, Hypodermic, Single Lumen; Syringe, Piston; Material, Impression; Agent, Absorbable Hemostatic, Collagen Based; Agent, Absorbable Hemostatic, Non-Collagen Based; Cleaner, Ultrasonic, Medical Instrument |
| Optik K & R Inc. | Contract manufacturer | 2 | Lens, Contact (Other Material) - Daily; Lens, Contact (Orthokeratology) |
| Innopex Limited | Foreign exporter | 89 | Dressing, Wound, Occlusive; System, Transport, Aerobic; Syringe, Piston; Catheter, Urological; Syringe, Irrigating (Non Dental); Catheter, Irrigation; Catheter, Ureteral, Gastro-Urology; Tubes, Vials, Systems, Serum Separators, Blood Collection; Dressing, Wound, Drug; Container, Specimen, Sterile |
| Can Technomed Trading Ltd. | Foreign exporter | 37 | System, X-Ray, Angiographic; System, X-Ray, Fluoroscopic, Image-Intensified; Interventional Fluoroscopic X-Ray System; Injector, Contrast Medium, Automatic; System, X-Ray, Tomography, Computed; System, Nuclear Magnetic Resonance Imaging; System, Nuclear Magnetic Resonance Spectroscopic; Instrument, Vitreous Aspiration And Cutting, Ac-Powered; Unit, Phacofragmentation; Densitometer, Bone |
| W&H Impex Inc. | Foreign exporter | 5 | Handpiece, Direct Drive, Ac-Powered; Controller, Foot, Handpiece And Cord; Scaler, Ultrasonic; Drill, Bone, Powered; Bur, Surgical, General & Plastic Surgery |
| Glaukos Corporation | Manufacturer | 1 | Lens, Condensing, Diagnostic |
| Gurunanda LLC | Specification developer (outsources manufacturing) | 1 | Wax, Dental, Intraoral |
| Synergy Health AST, LLC | Contract sterilizer | 1 | Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter |
| Clarity Design, Inc. | Contract manufacturer | 2 | Marker, Radiographic, Implantable; Device, Biofeedback |
| Evolve Manufacturing Technologies Inc. | Contract manufacturer | 1 | Eyelid Thermal Pulsation System |
| Biocheck, Inc. | Repackager or relabeler | 3 | Antigen, Ebv, Capsid; Visual, Pregnancy Hcg, Prescription Use; Helicobacter Pylori |
| HydraFacial LLC | Repackager or relabeler | 5 | Contact Cooling For Skin Lesion Pain Relief; Massager, Vacuum, Radio Frequency Induced Heat; Stimulator, Muscle, Powered; Pad, Heating, Powered; Stimulator, Nerve, Transcutaneous, For Pain Relief |
| iHealth Manufacturing Inc | Contract manufacturer | 1 | Multi-Analyte Respiratory Virus Antigen Detection Test |
| Integrity United Inc Dba Costcare | Other | 3 | Cart, Emergency, Cardiopulmonary (Excluding Equipment); Mattress, Air Flotation, Alternating Pressure; Mattress, Flotation Therapy, Non-Powered |
| PRO-TECH Design & Mfg, Inc. | Contract manufacturer | 1 | Stimulator, Peripheral Nerve, Implanted (Pain Relief) |
| Pro-Tech Design & Mfg., Inc. | Contract manufacturer | 1 | Stimulator, Peripheral Nerve, Implanted (Pain Relief) |
| Shenb America, Inc. | Other | 10 | Stimulator, Transcutaneous Electrical, Aesthetic Purposes; Electrosurgical, Cutting & Coagulation & Accessories; Stimulator, Muscle, Powered, For Muscle Conditioning; Aligner, Sequential; Massager, Vacuum, Radio Frequency Induced Heat |
| Sirius Engineering LLC | Contract manufacturer | 1 | Suture, Nonabsorbable, Synthetic, Polyamide |
| Lotfancy Inc | Repackager or relabeler | 3 | Dressing, Wound, Drug; Kit, Test, Pregnancy, Hcg, Over The Counter; Visual, Pregnancy Hcg, Prescription Use |
| Advanced Imaging Services, Inc. | Repackager or relabeler | 7 | System, Tomography, Computed, Emission; System, X-Ray, Tomography, Computed; Injector And Syringe, Angiographic; Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance; Injector, Contrast Medium, Automatic |
| Advantech Corporation | Contract manufacturer | 1 | Endoscopic Central Control Unit |
| Hitachi High-Tech America, Inc. Radiation Therapy Division | Contract manufacturer | 2 | System, Radiation Therapy, Charged-Particle, Medical |
| Skyward Medical Devices LLC | Repackager or relabeler | 28 | Exerciser, Non-Measuring; Orthosis, Cervical; Splint, Hand, And Components; Shield, Protective, Personnel; Orthosis, Thoracic; Portable Liquid Oxygen Unit Stand; Tray, Impression, Preformed; Catheter, Eustachian, General & Plastic Surgery; Vibrator For Therapeutic Use, Genital; Non-Surgical Gown |
| Planet Innovation Products, Inc. | Contract manufacturer | 1 | Real Time Nucleic Acid Amplification System |
| UPS Supply Chain Solutions, Inc. | Repackager or relabeler | 4 | Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates; System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates; Enzyme Linked Immunoabsorbent Assay, Rubeola Igg; Enzyme Linked Immunoabsorbent Assay, Mumps Virus |

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[All DeviceEstablishmentPulse record reports](/hub/deviceestablishmentpulse/records)

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