Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays

FDA 510(k)

FDA Class 2 ·Orthopedic

Equinoxe® Central Screw Baseplate System

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO IVENT 101

FDA 510(k)

FDA Class 2 ·Anesthesiology

APNEA RISK EVALUATION SYSTEM (ARES)

FDA 510(k)

FDA Class 2 ·Anesthesiology

ENGSTROM CARESTATION, ENGSTROM PRO

FDA 510(k)

FDA Class 2 ·Anesthesiology

INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IDC INTERLOCKING DETACHABLE COIL

FDA 510(k)

FDA Class 2 ·Cardiovascular

Uroject12 Syringe Lever

FDA 510(k)

FDA Class 2 ·General Hospital

SLEEP PROFILER

FDA 510(k)

FDA Class 2 ·Neurology

Vantage® Total Ankle System

FDA 510(k)

FDA Class 2 ·Orthopedic

Exactech® TRULIANT® Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

SLEEP PROFILER

FDA 510(k)

FDA Class 2 ·Neurology

AESPIRE 7900, AESPIRE VIEW

FDA 510(k)

FDA Class 2 ·Anesthesiology

DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Laser Hair Growth Cap

FDA 510(k)

FDA Class 2 ·Physical Medicine

MAGELLAN VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

MAGELLAN-2200, MODEL 1

FDA 510(k)

FDA Class 2 ·Anesthesiology

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·KONTUR SOFT (METHAFILCON A) CONTACT LNS

Axium Detachable Coil; Axium Prime Detachable Coil

FDA 510(k)

FDA Class 2 ·Neurology