Mesh, Surgical, Polymeric

FDA Pre-Market Approval

FDA Class 2 ·FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·TECHNOMED INTERNATIONAL SONOLITH 2000

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Atellica IM Analyzer Hepatitis C (aHCV)

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BOSTON LENS(R) CLEANER

Pulse-Generator, Pacemaker, External

FDA Pre-Market Approval

FDA Class 2 ·BEDSIDE(TM) SINGLE CHAMBER, TXTERNAL PULSE GENERATOR, MODEL 4170

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval

FDA Class 2 ·DEKLENE(TM)

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HCV

Suture, Absorbable, Natural

FDA Pre-Market Approval

FDA Class 2 ·CHROMIC GUT SUTURE

Suture, Nonabsorbable, Silk

FDA Pre-Market Approval

FDA Class 2 ·NONABSORBABLE SURG. SUTURES, BRAIDED SILK

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BOSTON LENS(R) CLEANER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Atellica IM Hepatitis C (aHCV) Assay

Light, Lymphedema Reduction, Low Energy

FDA classification

FDA Class 2 ·Light, Lymphedema Reduction, Low Energy

Post Breast Biopsy Hemostatic Breast Compression Device

FDA classification

FDA Class 2 ·Post Breast Biopsy Hemostatic Breast Compression Device

Laparoscopic Accessories, Esophageal Sizing

FDA classification

FDA Class 2 ·Laparoscopic Accessories, Esophageal Sizing

Ultrasonic Body Composition Analyzer

FDA classification

FDA Class 2 ·Ultrasonic Body Composition Analyzer

In Situ Polymerizing Peripheral Nerve Cap

FDA classification

FDA Class 2 ·In Situ Polymerizing Peripheral Nerve Cap

Plug, Scleral

FDA classification

FDA Class 2 ·Plug, Scleral

Electronic Depth Gauge

FDA classification

FDA Class 2 ·Electronic Depth Gauge

Multivariate Vital Signs Index

FDA classification

FDA Class 2 ·Multivariate Vital Signs Index