Dignitana AB DigniCap System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AF-180 HEMODIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AMDENT 2030, POLISHER/SCALER

FDA 510(k)

FDA Class 2 ·Dental

Reverso Pro System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

3D-SHAPER

FDA 510(k)

FDA Class 2 ·Radiology

LUCAS 3 Chest Compression System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Hermes Medical Imaging Suite v5.6

FDA 510(k)

FDA Class 2 ·Radiology

alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Leksell GammaPlan (LGP)

FDA 510(k)

FDA Class 2 ·Radiology

CT GUIDE (TM)

FDA 510(k)

FDA Class 2 ·Radiology

Tranberg CLS Thermal Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Natural Cycles

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Follicle Aspiration Set

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

NobelParallel Conical Connection

FDA 510(k)

FDA Class 2 ·Dental

NIOX VERO

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DEFCON TSA/TSH DENTAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

Vivo 60

FDA 510(k)

FDA Class 2 ·Anesthesiology

CONDOM (RUBBER LATEX) OKEIDO

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

RHEUMAJET RF

FDA 510(k)

FDA Class 2 ·Immunology