Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PRIME{TM} MODEL 6520, 6525, 6530 AND 6535

Stationary Infrared Thermometer

FDA classification

FDA Class 2 ·Stationary Infrared Thermometer

Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody

FDA classification

FDA Class 2 ·Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody

Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.

FDA classification

FDA Class 2 ·Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.

Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set

FDA classification

FDA Class 2 ·Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set

Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained

FDA classification

FDA Class 2 ·Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained

Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented

FDA classification

FDA Class 2 ·Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented

Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

FDA classification

FDA Class 2 ·Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

FDA classification

FDA Class 2 ·Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

Continuous Measurement Thermometer

FDA classification

FDA Class 2 ·Continuous Measurement Thermometer

Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

FDA classification

FDA Class 2 ·Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

FDA classification

FDA Class 2 ·Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter

FDA classification

FDA Class 2 ·Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter

Zinc Transporter 8 Auto-Antibody

FDA classification

FDA Class 2 ·Zinc Transporter 8 Auto-Antibody

Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera

FDA classification

FDA Class 2 ·Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera

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

FDA classification

FDA Class 2 ·Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer

FDA classification

FDA Class 2 ·Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer

Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

FDA classification

FDA Class 2 ·Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Automated Digital Image Manual Interpretation Microscope

FDA classification

FDA Class 2 ·Automated Digital Image Manual Interpretation Microscope

21-Hydroxylase Antibody (21-Ohab)

FDA classification

FDA Class 2 ·21-Hydroxylase Antibody (21-Ohab)