Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA)

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NC STORMER OVER-THE-WIRE BALLOON DILATATION CATHETER AND NC STORMER ZIPPER MX BALLOON DILATATION CATHETER

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER LITHOTRIPTER (STATIONARY AND MOBILE)

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·MEDSTONE STS-T LITHOTRIPTER

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·STOCKERT 70 RF GENERATOR WITH SOFTWARE VERSION 1.033

Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

FDA classification

FDA Class 2 ·Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

Vertebroplasty Compound, Calcium Based

FDA classification

FDA Class 2 ·Vertebroplasty Compound, Calcium Based

Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry

FDA classification

FDA Class 2 ·Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry

Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position

FDA classification

FDA Class 2 ·Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position

Aid, Cardiopulmonary Resuscitation

FDA classification

FDA Class 2 ·Aid, Cardiopulmonary Resuscitation

Accessory, System, External Fixator, Containing Antimicrobial Agent

FDA classification

FDA Class 2 ·Accessory, System, External Fixator, Containing Antimicrobial Agent

Cpr Aid Feedback Device (No Software)

FDA classification

FDA Class 2 ·Cpr Aid Feedback Device (No Software)

Automatic Event Detection Software For Polysomnograph With Electroencephalograph

FDA classification

FDA Class 2 ·Automatic Event Detection Software For Polysomnograph With Electroencephalograph

Early Growth Response 1 (Egr) Fish Probe Kit

FDA classification

FDA Class 2 ·Early Growth Response 1 (Egr) Fish Probe Kit

Biliary Stent System For Benign Strictures

FDA classification

FDA Class 2 ·Biliary Stent System For Benign Strictures

Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside

FDA classification

FDA Class 2 ·Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside

Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

FDA classification

FDA Class 2 ·Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

Cardiac Allograft Gene Expression Profiling Test System

FDA classification

FDA Class 2 ·Cardiac Allograft Gene Expression Profiling Test System