PHARMA-PLAST PURELINE(TM) BASIC(TM) AND PURELINE(TM) CONTACT(TM) SUBCUTANEOUS INFUSION SETS

FDA 510(k)

FDA Class 2 ·General Hospital

Lunderquist Extra Stiff Wire Guide

FDA 510(k)

FDA Class 2 ·Cardiovascular

Synvitro Hyadase

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption

FDA 510(k)

FDA Class 2 ·Neurology

ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80

FDA 510(k)

FDA Class 2 ·Physical Medicine

ABL8X7 FLEX

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ULTRASOUND SCANNER SYSTEM BK2300

FDA 510(k)

FDA Class 2 ·Radiology

POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ELLIPSE MULTIFLEX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Ensmile

FDA 510(k)

FDA Class 2 ·Dental

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

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

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

FDA 510(k)

FDA Class 2 ·Physical Medicine

SCANLISA HUMAN CRP ELISA KIT

FDA 510(k)

FDA Class 2 ·Immunology

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