JLK-CTP

FDA 510(k)

FDA Class 2 ·Radiology

ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MIROCAM CAPSULE ENDOSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Xcam

FDA 510(k)

FDA Class 2 ·Dental

EVS 2430W, EVS 2430GW

FDA 510(k)

FDA Class 2 ·Radiology

Well-life TM Pen Needles, Well-life TM Safety Pen Needles

FDA 510(k)

FDA Class 2 ·General Hospital

s-Clean OneQ-SL Narrow Implant System

FDA 510(k)

FDA Class 2 ·Dental

X-CUBE i8, X-CUBE i9

FDA 510(k)

FDA Class 2 ·Radiology

EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)

FDA 510(k)

FDA Class 2 ·Radiology

GM85

FDA 510(k)

FDA Class 2 ·Radiology

LATEX FINGER COTS

FDA 510(k)

FDA Class 1 ·General Hospital

AXIR-CX

FDA 510(k)

FDA Class 2 ·Radiology

VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Internal Hex Implant System

FDA 510(k)

FDA Class 2 ·Dental

Ensol EnTM Specimen Collection and Transport System

FDA 510(k)

FDA Class 1 ·Microbiology

Vonflex S Putty

FDA 510(k)

FDA Class 2 ·Dental

COMPRESSIBLE LIMB THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

SPECTACLE FRAMES

FDA 510(k)

FDA Class 1 ·Ophthalmic

HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EzDent Web

FDA 510(k)

FDA Class 2 ·Radiology