6420 Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

SMR TT Metal Back Glenoid, Bone Graft instruments

FDA 510(k)

FDA Class 2 ·Orthopedic

ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FIBER DISK AND BLOCK

FDA 510(k)

FDA Class 2 ·Dental

Limfa Therapy System (Limfa Therapy)

FDA 510(k)

FDA Class 2 ·Physical Medicine

COMPASS

FDA 510(k)

FDA Class 2 ·Ophthalmic

SpaceFlex Knee - 80mm Size

FDA 510(k)

FDA Class 2 ·Orthopedic

Piezosurgery White

FDA 510(k)

FDA Class 2 ·Dental

DERMA YAG

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BT-TITE ONE(BTICV1), BT-TITE STANDARD(BTIVSM), BT-TITE CV2(BTICV2)

FDA 510(k)

FDA Class 2 ·Dental

MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS

FDA 510(k)

FDA Class 2 ·Radiology

ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012

FDA 510(k)

FDA Class 2 ·Cardiovascular

Orthofix True Lok Hexapod System VI.3

FDA 510(k)

FDA Class 2 ·Orthopedic

Empatica Health Monitoring Platform

FDA 510(k)

FDA Class 2 ·Cardiovascular

EVO Platform

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MULTIGENT CREATININE (ENZYMATIC) ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)

FDA 510(k)

FDA Class 2 ·Cardiovascular

C2 femoral stem

FDA 510(k)

FDA Class 2 ·Orthopedic

CRONO FIVE AND CRONO PCA 50

FDA 510(k)

FDA Class 2 ·General Hospital