Microscope, Automated, Image Analysis, Operator Intervention

FDA classification

FDA Class 2 ·Microscope, Automated, Image Analysis, Operator Intervention

Injector, Vertebroplasty (Does Not Contain Cement)

FDA classification

FDA Class 1 ·Injector, Vertebroplasty (Does Not Contain Cement)

Hemodialysis Tray (Not A Start/Stop Kit)

FDA classification

FDA Class 2 ·Hemodialysis Tray (Not A Start/Stop Kit)

Internal Polymerase Chain Reaction Control, Not Assay Specific

FDA classification

FDA Class 1 ·Internal Polymerase Chain Reaction Control, Not Assay Specific

Mercury Vapor Lamp, Not Self-Extinguishing, R-Type

FDA classification

FDA Not Classified ·Mercury Vapor Lamp, Not Self-Extinguishing, R-Type

Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

FDA classification

FDA Class 2 ·Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

FDA classification

FDA Class 2 ·Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia

FDA classification

FDA Class 2 ·Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia

High Pressure Mercury, Metal Halide, And Mercury Xenon Lamp (Not For General Purpose Illumination)

FDA classification

FDA Not Classified ·High Pressure Mercury, Metal Halide, And Mercury Xenon Lamp (Not For General Purpose Illumination)

Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

FDA classification

FDA Not Classified ·Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

FDA classification

FDA Class 2 ·Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

FDA classification

FDA Not Classified ·Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

FDA classification

FDA Not Classified ·Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

Adhesive Backed Thermal Skin Patches

FDA classification

FDA Class 1 ·Adhesive Backed Thermal Skin Patches

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde

FDA classification

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde

Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

FDA classification

FDA Class 2 ·Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

Physiological Signal Based Seizure Monitoring System

FDA classification

FDA Class 2 ·Physiological Signal Based Seizure Monitoring System

Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System

FDA classification

FDA Class 1 ·Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System

Denture, Cosmetic Only

FDA classification

FDA Not Classified ·Denture, Cosmetic Only

Mitral Valve Repair Devices

FDA classification

FDA Class 3 ·Mitral Valve Repair Devices