TEMA Elbow System

FDA 510(k)

FDA Class 2 ·Orthopedic

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

C2 femoral stem

FDA 510(k)

FDA Class 2 ·Orthopedic

SMR Lateralized Connectors with screws

FDA 510(k)

FDA Class 2 ·Orthopedic

MasterSL femoral stem

FDA 510(k)

FDA Class 2 ·Orthopedic

Revision Femoral Stem

FDA 510(k)

FDA Class 2 ·Orthopedic

Physica PS Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

H-MAX S Femoral Hip System

FDA 510(k)

FDA Class 2 ·Orthopedic

SMR Hybrid Glenoid System

FDA 510(k)

FDA Class 2 ·Orthopedic

Hearing Aid, Air-Conduction With Wireless Technology, Prescription

FDA classification

FDA Class 2 ·Hearing Aid, Air-Conduction With Wireless Technology, Prescription

Tympanic Membrane Direct Contact Hearing Aid

FDA classification

FDA Class 2 ·Tympanic Membrane Direct Contact Hearing Aid

Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

FDA classification

FDA Class 2 ·Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

EPI-C PLUS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CLICK HOLTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PHYSICA KR KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

HDC STERILE SPIDER SCREW

FDA 510(k)

FDA Class 2 ·Dental

THD DISPOSABLE ANOSCOPE/PROCTOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Di (O-Hydroxyphenylimine) Ethane, Calcium

FDA classification

FDA Class 2 ·Di (O-Hydroxyphenylimine) Ethane, Calcium

Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

FDA classification

FDA Class 2 ·Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid