12 results · 7ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Materials, Repair Or Replacement, Pacemaker

FDA classification
FDA Class 3 ·Materials, Repair Or Replacement, Pacemaker

Material, Embolization, Neurovascular, Polymerizing Or Precipitating

FDA classification
FDA Class 3 ·Material, Embolization, Neurovascular, Polymerizing Or Precipitating

Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

FDA classification
FDA Class 3 ·Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

Stent, Urethral, Prostatic, Permanent Or Semi-Permanent

FDA classification
FDA Class 3 ·Stent, Urethral, Prostatic, Permanent Or Semi-Permanent

Caries Detection Product With Drug Or Biologic

FDA classification
FDA Class 3 ·Caries Detection Product With Drug Or Biologic

Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented

FDA classification
FDA Class 3 ·Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA classification
FDA Class 3 ·System, Test, Her-2/Neu, Nucleic Acid Or Serum

Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce

FDA classification
FDA Class 3 ·Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce

Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented

FDA classification
FDA Class 3 ·Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA classification
FDA Class 3 ·Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA classification
FDA Class 3 ·Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA classification
FDA Class 3 ·Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes