APROXI 1100 AND 4000 SERIES DENTAL INLAYS

FDA 510(k)

FDA Class 2 ·Dental

ARTSMedia In Vitro Culture Medium (AM-IVC Medium)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ABL90 FLEX

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system

FDA 510(k)

FDA Class 2 ·Neurology

SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Kudu

FDA 510(k)

FDA Class 1 ·Physical Medicine

VIBRECTOR

FDA 510(k)

FDA Unclassified ·Unknown

DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431

FDA 510(k)

FDA Class 2 ·Physical Medicine

WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Adora DRFi (04550010)

FDA 510(k)

FDA Class 2 ·Radiology

Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIASCOPE TRAVELLER PLUS (4053)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPECTACLE FRAME

FDA 510(k)

FDA Class 1 ·Ophthalmic

Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ortho System

FDA 510(k)

FDA Class 2 ·Dental

C.CAM-AC

FDA 510(k)

FDA Class 2 ·Radiology

ABL90

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ICS Impulse

FDA 510(k)

FDA Class 2 ·Neurology

neria guard Infusion Set

FDA 510(k)

FDA Class 2 ·General Hospital