REPROCESSED KENDALL SCD EXPRESS COMPRESSION SLEEVES

FDA 510(k)

FDA Class 2 ·Cardiovascular

LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GROOVY IMPLANTS

FDA 510(k)

FDA Class 2 ·Dental

CYSTOGLIDE INTRODUCER SHEATH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KNEEALIGN SYSTEM WITH REFERENCE SENSOR

FDA 510(k)

FDA Class 2 ·Neurology

HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module

FDA 510(k)

FDA Class 2 ·Cardiovascular

Sapphire X3 Anterior Cervical Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

ATAC PAK BUN REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HEARTPORT ENDOPULMONARY VENT

FDA 510(k)

FDA Class 2 ·Cardiovascular

STERNGOLD G-HARD METAL ALLOY

FDA 510(k)

FDA Class 2 ·Dental

CYBERLASE CO2 LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Provisio™ SLT IVUS™ System

FDA 510(k)

FDA Class 2 ·Cardiovascular

HIP TOOL IMPLANT

FDA 510(k)

FDA Class 2 ·Orthopedic

MICROVIT MT-100

FDA 510(k)

FDA Class 2 ·Cardiovascular

ECLIPSE 2100

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DRUGCHECK X MULTIDRUG SCREENING DEVICE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DUAL LEAD (ECG1 & ECG2) ARRHYTHMIA ANALYSIS

FDA 510(k)

FDA Class 2 ·Cardiovascular

GLASIONOMER FX-II

FDA 510(k)

FDA Class 2 ·Dental