C1-INHIBITOR MICROTITER ASSAY DEVICE

FDA 510(k)

FDA Class 2 ·Immunology

ULC SPINAL PEDICLE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

KITAZATO IUI CATHETER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DFS-2100

FDA 510(k)

FDA Class 2 ·Radiology

IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

OsseOne Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

OsseOne Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

VECTRA LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

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

cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

FDA 510(k)

FDA Class 2 ·Microbiology

cobas BKV

FDA 510(k)

FDA Class 2 ·Microbiology

Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)

FDA 510(k)

FDA Class 2 ·Microbiology

SIRIO H3

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