39 results · 40ms · Sources: EU EUDAMED, US FDA

Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit

FDA classification
FDA Class 2 ·Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit

Dermal Cooling Pack/Vacuum/Massager

FDA classification
FDA Class 2 ·Dermal Cooling Pack/Vacuum/Massager

Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter

FDA classification
FDA Class 1 ·Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter

Tips And Pads, Cane, Crutch And Walker

FDA classification
FDA Class 1 ·Tips And Pads, Cane, Crutch And Walker

External Urethral Occluder, Urinary Incontinence-Control, Female

FDA classification
FDA Class 1 ·External Urethral Occluder, Urinary Incontinence-Control, Female

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

Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis

FDA classification
FDA Not Classified ·Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis

Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt

FDA classification
FDA Class 1 ·Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt

Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use

FDA classification
FDA Class 1 ·Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use

Covid-19 Test Home Collection Kit Devices

FDA classification
FDA Not Classified ·Covid-19 Test Home Collection Kit Devices

Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

FDA classification
FDA Not Classified ·Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

Immunohistochemical Assay, Helicobacter Pylori

FDA classification
FDA Class 1 ·Immunohistochemical Assay, Helicobacter Pylori

Automated External Defibrillators (Non-Wearable)

FDA classification
FDA Class 3 ·Automated External Defibrillators (Non-Wearable)

Over-The-Counter Automated External Defibrillator

FDA classification
FDA Class 3 ·Over-The-Counter Automated External Defibrillator

Pierced Ear/Entry Cleaning Tray

FDA classification
FDA Class 1 ·Pierced Ear/Entry Cleaning Tray

High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.

FDA classification
FDA Class 2 ·High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.

General Purpose Reagent

FDA classification
FDA Class 1 ·General Purpose Reagent

Foot Examination Tool For Inflammatory Changes

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