THERMASCAN

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

SHARPLAN MODEL ULTRA ULTRASONIC SURG ASPIRATOR

FDA 510(k)

FDA Class 3 ·Unknown

SPINAL STABILIZING SPHERE SYSTEM

FDA 510(k)

FDA Class 3 ·Unknown

SPINAL SPHERES

FDA 510(k)

FDA Class 3 ·Unknown

THREADED PINS

FDA 510(k)

FDA Class 3 ·Unknown

SATELLITE SPINAL SYSTEM

FDA 510(k)

FDA Class 3 ·Unknown

ETHICON TEMPORARY CARDIAC PACING WIRE

FDA 510(k)

FDA Class 3 ·Unknown

PEEK SPINAL SPHERES

FDA 510(k)

FDA Class 3 ·Unknown

MODIFICATION TO: SATELLITE SPINAL SYSTEM

FDA 510(k)

FDA Class 3 ·Unknown

SPINAL SPHERE SYSTEM

FDA 510(k)

FDA Class 3 ·Unknown

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, Prostatic, Permanent Or Semi-Permanent

FDA classification

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

Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

FDA classification

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

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

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

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

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