35 results · 65ms · Sources: EU EUDAMED, US FDA

Pediatric/Child Facemask

FDA classification
FDA Class 2 ·Pediatric/Child Facemask

Biological Sterilization Indicator With Indirect Growth Detection

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

Rigid Sterilization Container With Software

FDA classification
FDA Class 2 ·Rigid Sterilization Container With Software

Computerized Cognitive Assessment Aid

FDA classification
FDA Class 2 ·Computerized Cognitive Assessment Aid

Closed Loop Auto Titration Device For Oral Appliances

FDA classification
FDA Class 2 ·Closed Loop Auto Titration Device For Oral Appliances

Covid-19 Multi-Analyte Antigen Device

FDA classification
FDA Not Classified ·Covid-19 Multi-Analyte Antigen Device

Hospital Cardiac Telemetry

FDA classification
FDA Class 2 ·Hospital Cardiac Telemetry

Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices

FDA classification
FDA Not Classified ·Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices

Software For Endoscopy Procedure Metrics

FDA classification
FDA Class 2 ·Software For Endoscopy Procedure Metrics

Ophthalmic Needle

FDA classification
FDA Class 2 ·Ophthalmic Needle

Foot Examination Tool For Inflammatory Changes

FDA classification
FDA Class 1 ·Foot Examination Tool For Inflammatory Changes

Biological Sterilization Process Indicator With Recombinant-Dna Plasmid

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

Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring

FDA classification
FDA Not Classified ·Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring

Intensive Care Unit, Respiratory Failure And Hemodynamic Instability Tool

FDA classification
FDA Not Classified ·Intensive Care Unit, Respiratory Failure And Hemodynamic Instability Tool

Device To Detect Microbial Colonization Directly From Clinical Specimens.

FDA classification
FDA Class 2 ·Device To Detect Microbial Colonization Directly From Clinical Specimens.

Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection

FDA classification
FDA Class 2 ·Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection

Ophthalmic Syringe

FDA classification
FDA Class 2 ·Ophthalmic Syringe

Low Dead Space Piston Syringe

FDA classification
FDA Class 2 ·Low Dead Space Piston Syringe

Left Ventricular Ejection Fraction Screening Tool

FDA classification
FDA Not Classified ·Left Ventricular Ejection Fraction Screening Tool

On-Body Injector

FDA classification
FDA Class 2 ·On-Body Injector