1,245 results · 28ms · Sources: EU EUDAMED, US FDA

Laser Absorbing Particles

FDA classification
FDA Class 2 ·Laser Absorbing Particles

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·ARTUS CMV RGQ MDX KIT

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST

Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.

FDA classification
FDA Class 2 ·Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.

Semi-Automated Autologous Skin Graft Harvesting And Application Device

FDA classification
FDA Class 2 ·Semi-Automated Autologous Skin Graft Harvesting And Application Device

Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter

FDA classification
FDA Class 2 ·Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented

FDA classification
FDA Class 2 ·Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented

Sunlamp Products (Pre-Standard)

FDA classification
FDA Class 2 ·Sunlamp Products (Pre-Standard)

Optical Coherence Tomography, Intravascular Catheter

FDA classification
FDA Class 2 ·Optical Coherence Tomography, Intravascular Catheter

Cutaneous Electrode Stimulator For Urinary Incontinence

FDA classification
FDA Class 2 ·Cutaneous Electrode Stimulator For Urinary Incontinence

Control, Fecal Occult Blood

FDA classification
FDA Class 2 ·Control, Fecal Occult Blood

Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter

FDA classification
FDA Class 2 ·Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter

Outpatient Cardiac Telemetry

FDA classification
FDA Class 2 ·Outpatient Cardiac Telemetry

Microscope, Specular

FDA classification
FDA Class 2 ·Microscope, Specular

Assay For Detection Of Proteases In Chronic Wounds

FDA classification
FDA Class 2 ·Assay For Detection Of Proteases In Chronic Wounds

Orthopedic Stereotaxic Instrument

FDA classification
FDA Class 2 ·Orthopedic Stereotaxic Instrument

System, Imaging, Optical Coherence Tomography (Oct)

FDA classification
FDA Class 2 ·System, Imaging, Optical Coherence Tomography (Oct)

Hospital Cardiac Telemetry

FDA classification
FDA Class 2 ·Hospital Cardiac Telemetry

Integrated Continuous Glucose Monitoring System, Factory Calibrated

FDA classification
FDA Class 2 ·Integrated Continuous Glucose Monitoring System, Factory Calibrated

Manual Instruments Designed For Use With Total Disc Replacement Devices

FDA classification
FDA Class 2 ·Manual Instruments Designed For Use With Total Disc Replacement Devices