470 results · 21ms · Sources: EU EUDAMED, US FDA

Bone Sonometer

FDA Pre-Market Approval
FDA Class 2 ·ACHILLES EXPRESS ULTRASONOMETER

Biological Sterilization Indicator With Indirect Growth Detection

FDA classification
FDA Class 2 ·Biological Sterilization Indicator With Indirect Growth Detection

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

FDA Pre-Market Approval
FDA Class 2 ·AMPLICOR HEPATITIS C VIRUS (HCV) TEST VERSION 2.0

Non-Normalizing Quantitative Electroencephalograph Software

FDA classification
FDA Class 2 ·Non-Normalizing Quantitative Electroencephalograph Software

Normalizing Quantitative Electroencephalograph Software

FDA classification
FDA Class 2 ·Normalizing Quantitative Electroencephalograph Software

Sheet, Recording, Breast Examination

FDA classification
FDA Class 2 ·Sheet, Recording, Breast Examination

Endoscopic Morcellator Gastroenterology

FDA classification
FDA Class 2 ·Endoscopic Morcellator Gastroenterology

Index-Generating Electroencephalograph Software

FDA classification
FDA Class 2 ·Index-Generating Electroencephalograph Software

Biological Sterilization Process Indicator With Recombinant-Dna Plasmid

FDA classification
FDA Class 2 ·Biological Sterilization Process Indicator With Recombinant-Dna Plasmid

Implantable Radio Frequency Transponder System

FDA classification
FDA Class 2 ·Implantable Radio Frequency Transponder System

Mass Spectrometry, Microorganism Identification, Blood Culture

FDA classification
FDA Class 2 ·Mass Spectrometry, Microorganism Identification, Blood Culture

Wound Retraction And Protection System

FDA classification
FDA Class 2 ·Wound Retraction And Protection System

Outpatient Cardiac Telemetry

FDA classification
FDA Class 2 ·Outpatient Cardiac Telemetry

Camera, Ophthalmic, Non-Prescription

FDA classification
FDA Class 2 ·Camera, Ophthalmic, Non-Prescription

Digital Physical/Chemical Sterilization Process Sensor

FDA classification
FDA Class 2 ·Digital Physical/Chemical Sterilization Process Sensor

Goniometer With Electrodes

FDA classification
FDA Class 2 ·Goniometer With Electrodes

Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device

FDA classification
FDA Class 2 ·Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device

Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization

FDA classification
FDA Class 2 ·Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization

Qualitative Cleaning Process Protein Indicator

FDA classification
FDA Class 2 ·Qualitative Cleaning Process Protein Indicator

Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies

FDA classification
FDA Class 2 ·Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies