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

HDC STERILE SPIDER SCREW

FDA 510(k)

FDA Class 2 ·Dental

THD DISPOSABLE ANOSCOPE/PROCTOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Muscular Dystrophy Newborn Screening Test

FDA classification

FDA Class 2 ·Muscular Dystrophy Newborn Screening Test

Di (O-Hydroxyphenylimine) Ethane, Calcium

FDA classification

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

Brain Trauma Assessment Test

FDA classification

FDA Class 2 ·Brain Trauma Assessment Test

Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System

FDA classification

FDA Class 2 ·Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System

MINIMA S System

FDA 510(k)

FDA Class 2 ·Orthopedic

AMF TT Cones

FDA 510(k)

FDA Class 2 ·Orthopedic

SMR Shoulder System

FDA 510(k)

FDA Class 2 ·Orthopedic

Delta Multihole TT Pro Acetabular System

FDA 510(k)

FDA Class 2 ·Orthopedic

SMR TT Augmented Glenoid System

FDA 510(k)

FDA Class 2 ·Orthopedic

Delta Multihole TT Pro Acetabular System

FDA 510(k)

FDA Class 2 ·Orthopedic