ASP-100, MODEL 2100

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Perfadex Plus

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Extroducer Infusion Catheter System

FDA 510(k)

FDA Class 2 ·Cardiovascular

HELAX-VISIR

FDA 510(k)

FDA Class 2 ·Radiology

OTS Hip

FDA 510(k)

FDA Class 2 ·Neurology

Tranberg CLS Laser Applicator

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PIM 1.0 LASER DOPPLER PERFUSION IMAGER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SyMRI

FDA 510(k)

FDA Class 2 ·Radiology

Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)

FDA 510(k)

FDA Class 2 ·Radiology

SERVO-U Ventilator System, SERVO-n Ventilator System

FDA 510(k)

FDA Class 2 ·Anesthesiology

Edi Catheter ENFit

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ETEST MEROPENEM

FDA 510(k)

FDA Class 2 ·Microbiology

THE E TEST CEFTIZOXIME

FDA 510(k)

FDA Class 2 ·Microbiology

Sectra Digital Pathology Module (Version 3.3)

FDA 510(k)

FDA Class 2 ·Pathology

EliA M2 Immunoassay

FDA 510(k)

FDA Class 2 ·Immunology

On1 Concept

FDA 510(k)

FDA Class 2 ·Dental

FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Coala Heart Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut

FDA 510(k)

FDA Class 2 ·Immunology

Cerament Bone Void Filler

FDA 510(k)

FDA Class 2 ·Orthopedic