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 ·ECONOLITH LITHOTRIPTER

Ceruloplasmin, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Ceruloplasmin, Antigen, Antiserum, Control

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCHNEIDER MICROSOFTRAC PTCA CATHETER SCHNEIDER FREEFLIGHT 20/30/40 PTCA CATHETER

Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·DIASORIN ETI-HA-IGMK PLUS

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·AB-HAVK, ETI-AB-HAVK, ETI-AB-HAVK PLUS

Human Lyophilized Dura Mater

FDA classification

FDA Class 2 ·Human Lyophilized Dura Mater

Immunoglobulin G (Igg) Infusion System

FDA classification

FDA Class 2 ·Immunoglobulin G (Igg) Infusion System

Infusion Pump, Drug Specific, Pharmacy-Filled

FDA classification

FDA Class 2 ·Infusion Pump, Drug Specific, Pharmacy-Filled

Digital Pathology Display

FDA classification

FDA Class 2 ·Digital Pathology Display

System, Suction, Lipoplasty

FDA classification

FDA Class 2 ·System, Suction, Lipoplasty

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV II TEST SYSTEM

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HCV READYPACKS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV II IMMUNOASSAY

Test, Methadone, Employment And Insurance Testing, Exempt

FDA classification

FDA Class 2 ·Test, Methadone, Employment And Insurance Testing, Exempt

Whole Exome Sequencing Constituent Device

FDA classification

FDA Class 2 ·Whole Exome Sequencing Constituent Device

Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt

FDA classification

FDA Class 2 ·Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt

Test, Opiates, Employment And Insurance Testing, Exempt

FDA classification

FDA Class 2 ·Test, Opiates, Employment And Insurance Testing, Exempt

Test, Codeine, Employment And Insurance Testing, Exempt

FDA classification

FDA Class 2 ·Test, Codeine, Employment And Insurance Testing, Exempt