Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

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

GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X

FDA 510(k)

FDA Class 2 ·Radiology

RSCRIBE ELECTROCARDIOGRAPH

FDA 510(k)

FDA Class 2 ·Cardiovascular

1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL

FDA 510(k)

FDA Class 2 ·Radiology

REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

HANDI-TRACTION

FDA 510(k)

FDA Class 2 ·Physical Medicine

NORLAND XR26 WHOLE BODY OPTION

FDA 510(k)

FDA Class 2 ·Radiology

INNOVA 3100

FDA 510(k)

FDA Class 2 ·Radiology

CT 9000

FDA 510(k)

FDA Class 2 ·Radiology

INSTRUMENTARIUM MEGA4

FDA 510(k)

FDA Class 2 ·Radiology

SIGNA BREAST COIL AND ARRAY ACCESSORY

FDA 510(k)

FDA Class 2 ·Radiology

CARE ELECTRIC BREAST PUMP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology