BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC,

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

BraidE Embolization Assist Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAGNETOM SYMPHONY A TIM SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

TIDI BRAND STERILIZATION WRAP

FDA 510(k)

FDA Class 2 ·General Hospital

HANAROSTENT Benefit Biliary (NNN)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MAGNETOM TRIO A TIM SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LEONARDO SYNGO CARDIOLOGY WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

KINETDX

FDA 510(k)

FDA Class 2 ·Radiology

Drivewire 24 Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

LEONARDO

FDA 510(k)

FDA Class 2 ·Radiology

GripMate

FDA 510(k)

FDA Class 2 ·General Hospital

EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRO

FDA 510(k)

FDA Class 2 ·Radiology

HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Zfx Abutments

FDA 510(k)

FDA Class 2 ·Dental

PEDIATRIC REFERENCE DATABASE

FDA 510(k)

FDA Class 2 ·Radiology

NovaGuard SA Pro Safety System

FDA 510(k)

FDA Class 2 ·General Hospital