BODYTRONIC 200

FDA 510(k)

FDA Class 2 ·Cardiovascular

ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE

FDA 510(k)

FDA Class 2 ·Physical Medicine

V5med Lung AI

FDA 510(k)

FDA Class 2 ·Radiology

ORTHOCOR KNEE SYSTEM BASIC

FDA 510(k)

FDA Class 2 ·Physical Medicine

LEGACY3 6MM LENGTH IMPLANTS

FDA 510(k)

FDA Class 2 ·Dental

INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

VENOTRAIN CURAFLOW

FDA 510(k)

FDA Class 2 ·General Hospital

mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator

MEDI-TEST COMBI 11

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

D.N.E. External Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Anovo Surgical System (6Ne)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CardiMax Electrocardiograph

FDA 510(k)

FDA Class 2 ·Cardiovascular

Anovo Surgical System (Model 6Ne)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CINE/VIEW PLUS - CARDIOLOGY WORKSTATION

FDA 510(k)

FDA Class 2 ·Cardiovascular