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

ß-Glucocerebrosidase (Gba) Newborn Screening Test System

FDA classification

FDA Class 2 ·ß-Glucocerebrosidase (Gba) Newborn Screening Test System

Intranasal Electrostimulation Device For Dry Eye Symptoms

FDA classification

FDA Class 2 ·Intranasal Electrostimulation Device For Dry Eye Symptoms

Alpha-D-Glucosidase (Gaa) Newborn Screening Test System

FDA classification

FDA Class 2 ·Alpha-D-Glucosidase (Gaa) Newborn Screening Test System

Alpha-L-Iduronidase (Idua) Newborn Screening Test System

FDA classification

FDA Class 2 ·Alpha-L-Iduronidase (Idua) Newborn Screening Test System

Alpha-D-Galactosidase A (Gla) Newborn Screening Test System

FDA classification

FDA Class 2 ·Alpha-D-Galactosidase A (Gla) Newborn Screening Test System

Two Or More Sterilant Sterilizer

FDA classification

FDA Class 2 ·Two Or More Sterilant Sterilizer

ß-Galactocerebrosidase (Galc) Newborn Screening Test System

FDA classification

FDA Class 2 ·ß-Galactocerebrosidase (Galc) Newborn Screening Test System

Acid-Sphingomyelinase (Asm) Newborn Screening Test System

FDA classification

FDA Class 2 ·Acid-Sphingomyelinase (Asm) Newborn Screening Test System

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