Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip G5 System

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·PASCAL Precision Transcatheter Valve Repair System

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·PASCAL Precision Transcatheter Valve Repair System

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip™ G4 Clip Delivery System

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip NTR Clip Delivery System, MitraClip XTR Clip Delivery System, and MitraClip G4 Clip Delivery System

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip™ G4 Clip Delivery System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

LIVESIRE ELECTROPHYSIOLOGY CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CEEMAX SLIT LAMP (HALOGEN LAMP SERIES/SOLID STATE ILLUMINATION SERIES)

FDA 510(k)

FDA Class 2 ·Ophthalmic

PRECISION CAPILLARIES FOR MICROMANIPULATION

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

RIVER VIAL ADAPTER

FDA 510(k)

FDA Class 2 ·General Hospital

SHUTTLE STOP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RAPIDIA

FDA 510(k)

FDA Class 2 ·Radiology

MEDRAD QUAD C-SPINE COIL, 1.5T MODEL, M64CSC, 1.0T MODEL M42CSC

FDA 510(k)

FDA Class 2 ·Radiology

BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFICATION TO NC-STAT

FDA 510(k)

FDA Class 2 ·Neurology

SOLOSITE GEL CONFORMABLE DRESSING

FDA 510(k)

FDA Unclassified ·Unknown

RDIOGRAPHIC WALL HOLDER OR FILM RECEPTOR

FDA 510(k)

FDA Class 1 ·Radiology

CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0

FDA 510(k)

FDA Unclassified ·Unknown

AUTION MAX AX-4280 URINALYSIS SYSTEM

FDA 510(k)

FDA Class 1 ·Clinical Chemistry