DeviceEstablishmentPulse: records in California, page 2 of 3
Records 51 to 200 of the 284 newest listed for this hub. Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
| Record | Role | New listings | Devices |
|---|---|---|---|
| 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 | Orthopedic Stereotaxic Instrument; Thoracolumbosacral Pedicle Screw System |
| Carlsmed, Inc. | Manufacturer | 2 | Appliance, Fixation, Spinal Intervertebral Body |
| Cutera, Inc. | Manufacturer | 2 | Electrosurgical, Cutting & Coagulation & Accessories; Powered Laser Surgical Instrument |
| 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 |
| 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 |
| 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 |
| Tecan Cdmo Solutions Mh, Corp. | Contract manufacturer | 3 | Deformability Cytometry For Sepsis Risk Assessment |
| 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 |
| 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 |
| Proguard Health Inc. | Contract manufacturer | 5 | Handpiece, Air-Powered, Dental; Handpiece, Contra- And Right-Angle Attachment, Dental; Activator, Ultraviolet, For Polymerization; Cup, Prophylaxis |
| Trelleborg Sealing Solutions Us, Inc. | Contract manufacturer | 3 | Implant, Eye Valve; Splint, Intranasal Septal; 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 |
| Lumiquick Diagnostics, Inc. | Contract manufacturer | 1 | Enzyme Linked Immunosorbent Assay, Coccidioides Immitis |
| 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 |
| 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 |
| 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 |
| 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 |
| Conavi Medical Inc | Specification developer (outsources manufacturing) | 3 | System, Imaging, Optical Coherence Tomography (Oct); System, Imaging, Pulsed Echo, Ultrasonic; Catheter, Ultrasound, Intravascular |
| AMD Medicom Inc. | Manufacturer | 9 | Polymer Patient Examination Glove; Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs; Medical Glove, Specialty; Powder-Free Polychloroprene Patient Examination Glove; Fentanyl And Other Opioid Protection Glove |
| Primed Medical Products Inc. | Specification developer (outsources manufacturing) | 2 | Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs; Gown, Isolation, Surgical |
| 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 | Anti-Factor Xa Activity Test System, Apixaban; Enzyme Immunoassay, Benzodiazepine |
| Emboline Inc | Manufacturer | 1 | Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures |
| Prismatik Dentalcraft, Inc. | Manufacturer | 2 | Resin, Denture, Relining, Repairing, Rebasing; Powder, Porcelain |
| 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; Fentanyl And Other Opioid Protection Glove; Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs; 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 | Laser, Ophthalmic; Drape, Surgical, Exempt |
| 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 |
| 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) | 4 | Latex Patient Examination Glove; Accessories, Retractor, Dental; Finger Cot |
| 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 | Table, Operating-Room, Electrical; Wound Dressing With Animal-Derived Material(S); 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 | Denture, Plastic, Teeth; Material, Tooth Shade, Resin |
| Sprintray Inc. | Specification developer (outsources manufacturing) | 2 | Denture, Plastic, Teeth; Material, Tooth Shade, Resin |
| 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 |
| Borvo Medical, Inc. | Specification developer (outsources manufacturing) | 1 | Clamp, Surgical, General & Plastic Surgery |
| Kash Sales Inc. | Foreign exporter | 15 | Agent, Absorbable Hemostatic, Collagen Based; Material, Impression; Needle, Hypodermic, Single Lumen; Syringe, Piston; Cement, Dental; Agent, Absorbable Hemostatic, Non-Collagen Based; Mask, Surgical; Cleaner, Ultrasonic, Medical Instrument; Tubes, Vials, Systems, Serum Separators, Blood Collection; Mouthpiece, Saliva Ejector |
| 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 | 40 | System, Tomography, Computed, Emission; System, X-Ray, Tomography, Computed; System, X-Ray, Mammographic; Injector And Syringe, Angiographic; Densitometer, Bone; System, X-Ray, Tomographic; System, X-Ray, Stationary; Solid State X-Ray Imager (Flat Panel/Digital Imager); System, Nuclear Magnetic Resonance Imaging; System, Nuclear Magnetic Resonance Spectroscopic |
| W&H Impex Inc. | Foreign exporter | 8 | Sterilizer, Steam; Handpiece, Direct Drive, Ac-Powered; Bur, Surgical, General & Plastic Surgery; Catheter, Irrigation; Controller, Foot, Handpiece And Cord; Scaler, Ultrasonic; Drill, Bone, Powered |
| Glaukos Corporation | Manufacturer | 1 | Lens, Condensing, Diagnostic |
| Gurunanda LLC | Specification developer (outsources manufacturing) | 1 | Wax, Dental, Intraoral |
| Apostle Inc. | Specification developer (outsources manufacturing) | 1 | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
| Evolve Manufacturing Technologies Inc. | Contract manufacturer | 1 | Eyelid Thermal Pulsation System |
| Biocheck, Inc. | Repackager or relabeler | 3 | Helicobacter Pylori; Visual, Pregnancy Hcg, Prescription Use; Antigen, Ebv, Capsid |
| HydraFacial LLC | Repackager or relabeler | 5 | Stimulator, Muscle, Powered; Pad, Heating, Powered; Stimulator, Nerve, Transcutaneous, For Pain Relief; Contact Cooling For Skin Lesion Pain Relief; Massager, Vacuum, Radio Frequency Induced Heat |
| iHealth Manufacturing Inc | Contract manufacturer | 1 | Multi-Analyte Respiratory Virus Antigen Detection Test |
| Integrity United Inc Dba Costcare | Other | 3 | Mattress, Air Flotation, Alternating Pressure; Cart, Emergency, Cardiopulmonary (Excluding Equipment); 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 | Electrosurgical, Cutting & Coagulation & Accessories; Stimulator, Transcutaneous Electrical, Aesthetic Purposes; Massager, Vacuum, Radio Frequency Induced Heat; Stimulator, Muscle, Powered, For Muscle Conditioning; Aligner, Sequential |
| Sirius Engineering LLC | Contract manufacturer | 1 | Suture, Nonabsorbable, Synthetic, Polyamide |
| Lotfancy Inc | Repackager or relabeler | 3 | Dressing, Wound, Drug; Visual, Pregnancy Hcg, Prescription Use; Kit, Test, Pregnancy, Hcg, Over The Counter |
| Advanced Imaging Services, Inc. | Repackager or relabeler | 7 | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance; System, X-Ray, Tomography, Computed; System, Tomography, Computed, Emission; Injector And Syringe, Angiographic; 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 | Shield, Protective, Personnel; Vibrator For Therapeutic Use, Genital; Catheter, Eustachian, General & Plastic Surgery; Sling, Arm; Portable Liquid Oxygen Unit Stand; Crutch; Orthosis, Thoracic; Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Shoe, Cast; Support, Arm |
| Planet Innovation Products, Inc. | Contract manufacturer | 1 | Real Time Nucleic Acid Amplification System |
| UPS Supply Chain Solutions, Inc. | Repackager or relabeler | 4 | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg; Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates; Enzyme Linked Immunoabsorbent Assay, Mumps Virus; System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates |
| Fusionx Medtech Inc. | Repackager or relabeler | 22 | Instrument, Manual, Surgical, General Use; Intervertebral Fusion Device With Bone Graft, Lumbar; Tape, Measuring, Rulers And Calipers; Guide, Needle, Surgical; Retractor; Orthopedic Manual Surgical Instrument; Pusher, Socket; Bender; Impactor; Instrument, Compression |
| Ads Dental System Inc. | Repackager or relabeler | 7 | Controller, Foot, Handpiece And Cord; Locator, Root Apex; Handpiece, Direct Drive, Ac-Powered; Handpiece, Contra- And Right-Angle Attachment, Dental; Handpiece, Air-Powered, Dental; Scaler, Ultrasonic |
| iCRco Inc. | Repackager or relabeler | 5 | Camera, Multi Format, Radiological; System, X-Ray, Mobile; Solid State X-Ray Imager (Flat Panel/Digital Imager); System, X-Ray, Stationary |
| Scientific Molding Corporation Ltd. Dba Smc Ltd. | Contract manufacturer | 2 | Left Atrial Appendage Clip, Implantable; Probe, Radiofrequency Lesion |
| Watershed Idea Foundry, Inc. | Contract manufacturer | 2 | Intervertebral Fusion Device With Integrated Fixation, Cervical; Intervertebral Fusion Device With Bone Graft, Cervical |
| Sterigenics U.S., LLC | Contract sterilizer | 2 | Alternate Controller Enabled Insulin Infusion Pump; Instrument, Biopsy |
| Boston Aesthetics Inc | Other | 7 | Powered Laser Surgical Instrument; Electrosurgical, Cutting & Coagulation & Accessories; Massager, Vacuum, Radio Frequency Induced Heat |
| M4d LLC | Contract manufacturer | 2 | Catheter, Percutaneous, Neurovasculature; Catheter, Percutaneous |
| Eurofins Infinity Laboratory Group Inc. | Contract sterilizer | 1 | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Zyllion, Inc. | Repackager or relabeler | 1 | Lamp, Infrared, Therapeutic Heating |
| Persyst Development LLC | Other | 1 | Source Localization Software For Electroencephalograph Or Magnetoencephalograph |
| Si-Bone, Inc. | Other | 2 | Orthopedic Stereotaxic Instrument; Thoracolumbosacral Pedicle Screw System |
| Ivd Research, LLC. | Contract manufacturer | 1 | Lactoferrin, Antigen, Antiserum, Control |
| Beyes Dental Inc | Manufacturer | 3 | Gutta-Percha; Point, Paper, Endodontic; File, Pulp Canal, Endodontic |
| Custom Foam Systems, Ltd. | Manufacturer | 1 | Stretcher, Wheeled |
| KARDIUM Inc. | Specification developer (outsources manufacturing) | 1 | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| ResolutionMD, Inc. | Manufacturer | 1 | System, Image Processing, Radiological |
| Moca Test Inc. | Manufacturer | 1 | Computerized Cognitive Assessment Aid, Exempt |
| Adaptiiv Medical Technologies, Inc. | Manufacturer | 1 | System, Planning, Radiation Therapy Treatment |
| Voxneuro, Inc. | Manufacturer | 1 | Normalizing Quantitative Electroencephalograph Software |
| Dna Genotek, Inc. | Manufacturer | 1 | Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay |
| Ortho Attachyhook Supply Ltd. | Specification developer (outsources manufacturing) | 1 | Bracket, Ceramic, Orthodontic |
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