485 results · 41ms · Sources: EU EUDAMED, US FDA

Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

FDA classification
FDA Class 2 ·Over-The-Counter Molecular Test To Detect Sars-Cov-2 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

Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, Prescription Use

FDA classification
FDA Class 2 ·Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, Prescription Use

Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples

FDA classification
FDA Class 2 ·Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples

Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures

FDA classification
FDA Class 2 ·Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures

Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

FDA classification
FDA Class 3 ·Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

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

Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells

FDA classification
FDA Class 1 ·Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells

Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers

FDA classification
FDA Class 2 ·Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers

Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents

FDA classification
FDA Class 3 ·Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents

Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

FDA classification
FDA Not Classified ·Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

Two Or More Sterilant Sterilizer

FDA classification
FDA Class 2 ·Two Or More Sterilant Sterilizer

Venipuncture Kit

FDA classification
FDA Class 2 ·Venipuncture Kit

Chamber, Patient Transport Isolation

FDA classification
FDA Class 2 ·Chamber, Patient Transport Isolation

Ophthalmic Syringe

FDA classification
FDA Class 2 ·Ophthalmic Syringe

Nursing Pad, Cohesive Gel

FDA classification
FDA Class 1 ·Nursing Pad, Cohesive Gel

Legging, Compression, Non-Inflatable

FDA classification
FDA Class 2 ·Legging, Compression, Non-Inflatable

Bed, Pediatric Open Hospital

FDA classification
FDA Class 2 ·Bed, Pediatric Open Hospital

Device, Germicidal, Ultraviolet

FDA classification
FDA Class 2 ·Device, Germicidal, Ultraviolet

Latex Patient Examination Glove

FDA classification
FDA Class 1 ·Latex Patient Examination Glove