LW Implant System – Abutment

FDA 510(k)

FDA Class 2 ·Dental

REXMONO, PDREX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Stella

FDA 510(k)

FDA Class 2 ·Dental

Clear-Tip EUS-FNA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG

FDA 510(k)

FDA Class 2 ·Immunology

Fortis and Hana Anterior Cervical Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

CORE-CLIP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HEARTLINK, MODEL II

FDA 510(k)

FDA Class 2 ·Cardiovascular

CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KSEA OPSERVER LAP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ANAX™ OCT Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS

FDA 510(k)

FDA Class 2 ·Neurology

AUTOCON II 200 ELECTROSURGICAL GENERATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

COULTER CLONE T1 MONOCLONAL ANTIBODY

FDA 510(k)

FDA Class 2 ·Hematology

ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR

FDA 510(k)

FDA Class 2 ·Radiology

ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology