DeviceEstablishmentPulse: records in California, page 3 of 3
Records 201 to 284 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 |
|---|---|---|---|
| Keter Canada Inc. | Manufacturer | 1 | Container, Sharps |
| Medtronic CryoCath LP | Manufacturer | 1 | Cardiac Ablation Percutaneous Catheter |
| Clarius Mobile Health Corp. | Manufacturer | 1 | Automated Radiological Image Processing Software |
| Covalon Technologies Inc. | Manufacturer | 1 | Wound Dressing With Animal-Derived Material(S) |
| BTNX Inc. | Repackager or relabeler | 11 | Test, Phencyclidine (Pcp), Over The Counter; Test, Barbiturate, Over The Counter; Test, Cocaine And Cocaine Metabolites, Over The Counter; Test, Propoxyphene, Over The Counter; Test, Benzodiazepine, Over The Counter; Test, Methamphetamine, Over The Counter; Test, Opiates, Over The Counter; Test, Amphetamine, Over The Counter; Test, Tricyclic Antidepressants, Over The Counter; Test, Cannabinoid, Over The Counter |
| Diadent Group Intl., Inc. | Foreign exporter | 6 | Material, Tooth Shade, Resin; Material, Impression; Cement, Dental |
| Creation Technologies Ltd | Contract manufacturer | 1 | Computer, Diagnostic, Programmable |
| 15445361 Canada Inc. | Foreign exporter | 25 | Container, Liquid Medication, Graduated; Syringe, Irrigating (Non Dental); Electrode, Electrocardiograph; Catheter, Retention Type, Balloon; System, Thermal Regulating; Non-Surgical Gown; Marker, Skin; Cap, Surgical; Syringe, Piston; Cannula, Surgical, General & Plastic Surgery |
| Apple Inc. | Manufacturer | 1 | Accessories, Wheelchair |
| Becton Dickinson Canada Inc. | Foreign exporter | 12 | Computer, Diagnostic, Programmable; Stylet For Catheter, Gastro-Urology; System, Measurement, Blood-Pressure, Non-Invasive; Adjunctive Open Loop Fluid Therapy Recommender; Medium-Term Adjunctive Predictive Cardiovascular Indicator; Cerebral Oximeter; Adjunctive Predictive Cardiovascular Indicator; Oximeter, Tissue Saturation; Catheter, Oximeter, Fiber-Optic; Catheter, Flow Directed |
| Solutionbased, Inc. | Specification developer (outsources manufacturing) | 1 | Aid, Transfer |
| Beta Bionics, Inc. | Manufacturer | 1 | Continuous Glucose Monitor Retrospective Data Analysis Software |
| Basic Medical Technology Inc. | Manufacturer | 1 | Wheelchair, Mechanical |
| Fte Dynamics, LLC | Specification developer (outsources manufacturing) | 1 | Flowmeter, Tube, Thorpe, Back-Pressure Compensated |
| AG Marketing & Development Group Inc Dba Agmd Group | Foreign exporter | 20 | Tubes, Vials, Systems, Serum Separators, Blood Collection; Needle, Hypodermic, Single Lumen; Syringe, Piston; Polymer Patient Examination Glove; Mask, Surgical; Warmer, Blood, Non-Electromagnetic Radiation; Vinyl Patient Examination Glove; Needle, Aspiration And Injection, Disposable; Set, Administration, Intravascular; Pediatric/Child Facemask |
| Merit Medical Canada Ltd. | Foreign exporter | 6 | Dilator, Vessel, For Percutaneous Catheterization; Catheter, Embolectomy; Endoscopic Irrigation/Suction System; Unit, Cryosurgical, Accessories; Endoscopic Access Overtube, Gastroenterology-Urology |
| Ashtel Studios, Inc. | Specification developer (outsources manufacturing) | 1 | Radiographic Protective Glove |
| Lifescience Plus, Inc. | Manufacturer | 1 | Hemostatic Wound Dressing Without Thrombin Or Other Biologics |
| Ansell Sandel Medical Solutions LLC | Specification developer (outsources manufacturing) | 1 | Bag, Urine Collection, Leg, For External Use, Non-Sterile |
| Aceso Laboratories Inc. | Manufacturer | 1 | Test, Follicle Stimulating Hormone (Fsh), Over The Counter |
| Seegene USA Inc. | Manufacturer | 1 | Reagents, Monkeypox Virus Nucleic Acid. |
| Johnson & Johnson Surgical Vision, Inc. | Manufacturer | 1 | Lens, Guide, Intraocular |
| Patterson Dental Canada Inc. | Repackager or relabeler | 4 | Device, Caries Detection; Handpiece, Air-Powered, Dental; Cord, Retraction; Resin, Root Canal Filling |
| Terumo Medical Canada, Inc. | Foreign exporter | 4 | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter; Hybrid Stent Graft, Thoracic Aortic Lesion Treatment |
| Oasis Medical, Inc. | Specification developer (outsources manufacturing) | 1 | Pack, Hot Or Cold, Disposable |
| Siemens Healthcare Limited | Foreign exporter | 3 | Digital Breast Tomosynthesis; Solid State X-Ray Imager (Flat Panel/Digital Imager); System, X-Ray, Stationary |
| Biowy Corporation | Manufacturer | 2 | Container, Frozen Donor Tissue Storage |
| Parnell Pharmaceuticals, Inc. | Specification developer (outsources manufacturing) | 1 | Unit, Oral Irrigation |
| MILLENNIUM MEDICAL TECHNOLOGIES INC./DBA Cellmyx | Specification developer (outsources manufacturing) | 1 | Brush, Dermabrasion, Powered |
| Secada Medical, LLC D.B.A Ventris Medical | Specification developer (outsources manufacturing) | 1 | Wound Dressing With Animal-Derived Material(S) |
| Los Angeles Collective, LLC | Specification developer (outsources manufacturing) | 1 | Sunglasses (Non-Prescription Including Photosensitive) |
| Sterigenics EO Canada, Inc. | Contract sterilizer | 2 | Transducer, Ultrasonic, Diagnostic; Catheter, Intravascular, Diagnostic |
| Vista Industries, LLC. | Manufacturer | 1 | Polymer Patient Examination Glove |
| Avacen, Inc. | Specification developer (outsources manufacturing) | 1 | Device, Intravascular Catheter Securement |
| Kj Korea Inc | Manufacturer | 1 | Massager, Therapeutic, Electric |
| Ckvulpeculae, LLC | Manufacturer | 1 | Digital Visual Acuity Test |
| Magnum Opus Agency LLC | Specification developer (outsources manufacturing) | 1 | Sunglasses (Non-Prescription Including Photosensitive) |
| EverBrands, Inc. | Manufacturer | 2 | Tray, Surgical, Instrument; Gauge, Depth, Instrument, Dental |
| Center Health Inc. | Manufacturer | 1 | Continuous Glucose Monitor Retrospective Data Analysis Software |
| Knowledge Media LLC | Manufacturer | 1 | Tape And Bandage, Adhesive |
| New Life Diagnostics Inc. | Manufacturer | 1 | Device, General Purpose, Microbiology, Diagnostic |
| MEDTOX Diagnostics, Inc. | Manufacturer | 1 | System, Blood Collection, Vacuum-Assisted, Manual |
| Zeta Corporation | Manufacturer | 1 | Reagents, Specific, Analyte |
| Solventum Orthodontics Corporation | Manufacturer | 1 | Tray, Impression, Preformed |
| Biolinq Incorporated | Manufacturer | 1 | Tape And Bandage, Adhesive |
| Lu Mark USA Enterprises Inc | Specification developer (outsources manufacturing) | 1 | Splint, Extremity, Inflatable, External |
| Frontier Dental Supply Inc | Foreign exporter | 12 | Sealant, Pit And Fissure, And Conditioner; Material, Impression; Agent, Tooth Bonding, Resin; Cement, Dental; Material, Tooth Shade, Resin; Crown And Bridge, Temporary, Resin; Adhesive, Bracket And Tooth Conditioner, Resin |
| Clear Labs, Inc | Manufacturer | 1 | Station, Pipetting And Diluting, For Clinical Use |
| J. Sterling Industries Ltd. | Contract manufacturer | 1 | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Sureax Medical, Corporation | Manufacturer | 1 | Guide, Needle, Surgical |
| Southmedic, Inc. | Contract manufacturer | 1 | Container, Specimen, Sterile |
| Aluris Sciences, LLC | Contract manufacturer | 1 | Multi-Analyte Controls Unassayed |
| Gurin Products LLC | Repackager or relabeler | 2 | Stimulator, Nerve, Transcutaneous, Over-The-Counter; Stimulator, Muscle, Powered, For Muscle Conditioning |
| Fisher & Paykel Healthcare, Inc. | Other | 1 | Humidifier, Respiratory Gas, (Direct Patient Interface) |
| Shofu Dental Corp. | Repackager or relabeler | 1 | Powder, Porcelain |
| Den-Mat Holdings, LLC | Repackager or relabeler | 1 | Material, Tooth Shade, Resin |
| Healthy Hair Inc | Repackager or relabeler | 1 | Laser, Comb, Hair |
| Happy Heart Care Services, LLC | Repackager or relabeler | 2 | System, Measurement, Blood-Pressure, Non-Invasive |
| DBM Corporation USA | Repackager or relabeler | 1 | Powered Microneedle Device |
| LetsGetChecked Inc. | Other | 1 | Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay |
| Hubdic USA Inc | Other | 2 | Stimulator, Nerve, Transcutaneous, Over-The-Counter; Stimulator, Muscle, Powered, For Muscle Conditioning |
| Sleepcare, LLC | Repackager or relabeler | 2 | Positioner, Tooth, Preformed; Material, Impression |
| Bear Down Brands, LLC Chino Warehouse | Repackager or relabeler | 1 | Clinical Electronic Thermometer |
| Mendtronix, Inc. | Repackager or relabeler | 1 | Electrocardiograph, Ambulatory (Without Analysis) |
| Color Diagnostics, LLC | Repackager or relabeler | 1 | Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay |
| Smwmed Inc. | Other | 1 | Recorder, Magnetic Tape, Medical |
| MRIMed Inc. DBA: Quality Safety Tools | Repackager or relabeler | 1 | Handle, Scalpel |
| Rmac Surgical Inc | Manufacturer | 1 | Instrument, Manual, Surgical, General Use |
| Upper Cervical Store, Inc. | Manufacturer | 1 | Monitor, Spine Curvature |
| Choice One Medical Inc | Manufacturer | 1 | Tubing, Pressure And Accessories |
| Vgh Solutions Inc | Foreign exporter | 1 | Powered Laser Surgical Instrument |
| Thermor Ltd. | Foreign exporter | 1 | System, Measurement, Blood-Pressure, Non-Invasive |
| Ivoclar Vivadent, Inc. | Foreign exporter | 1 | Material, Tooth Shade, Resin |
| Lesieur Entreprises Inc. | Foreign exporter | 1 | Lenses, Soft Contact, Daily Wear |
| Imperial Optical, Inc | Foreign exporter | 1 | Lenses, Soft Contact, Extended Wear |
| Canadian Imaging Services Inc. | Foreign exporter | 2 | Interventional Fluoroscopic X-Ray System; System, X-Ray, Fluoroscopic, Image-Intensified |
| Prism Pacific Industries LLC | Repackager or relabeler | 2 | Protector, Skin Pressure; Bedding, Disposable, Medical |
| Babylist, Inc. | Repackager or relabeler | 2 | Pack, Hot Or Cold, Reusable; Massager, Therapeutic, Electric |
| Airicu Inc. | Other | 1 | Circuit, Breathing (W Connector, Adaptor, Y Piece) |
| Gibbons Health Products, Inc. | Repackager or relabeler | 1 | Massager, Therapeutic, Manual |
| Us Health Express Corp | Other | 1 | Polymer Patient Examination Glove |
| Fill It Pack It Inc | Repackager or relabeler | 1 | Dressing, Wound, Drug |
| Drnoah Us Inc | Repackager or relabeler | 1 | Toothbrush, Manual |
| Garaventa (Canada) Ltd. | Repackager or relabeler | 1 | Chair, Adjustable, Mechanical |
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