OsseOne Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

OsseOne Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

Blue Phantom PT

FDA 510(k)

FDA Class 2 ·Radiology

VECTRA LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OMNIPRO INCLINE

FDA 510(k)

FDA Class 2 ·Radiology

CorticaLINK Spinal Fusion Platform

FDA 510(k)

FDA Class 2 ·Orthopedic

MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT

FDA 510(k)

FDA Class 2 ·Neurology

Kangaroo Feeding Tube with IRIS Technology

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VertebraLINK Fusion Platform

FDA 510(k)

FDA Class 2 ·Orthopedic

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

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·AFFINITY ANTERIOR CERVICAL CAGE SYSTEM

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

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

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·INTER FIX THREADED FUSION DEVICE, INTER FIX RP THREADED FUSION DEVICE AND LT-CAGE LUMBAR TAPERED FUSION DEVICE

SIRIO H3

FDA 510(k)

FDA Class 2 ·Radiology

INTELEPACS, MODEL VERSION 3.X.X

FDA 510(k)

FDA Class 2 ·Radiology

QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP

FDA 510(k)

FDA Class 2 ·Cardiovascular

SleepImage System

FDA 510(k)

FDA Class 2 ·Anesthesiology

MBA Biotech Implant System

FDA 510(k)

FDA Class 2 ·Dental

GOLNIT Non-Absorbable PTFE Surgical Suture

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery