REVISED LABELING FOR SYVA COCAINE METABOLITE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIAGNOSOFT HARP

FDA 510(k)

FDA Class 2 ·Radiology

ACTA VESSEL OCCLUSION SYSTEM (VOS)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Identify

FDA 510(k)

FDA Class 2 ·Radiology

Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon

FDA 510(k)

FDA Class 2 ·Radiology

COHERENT XA-50, X30/CW, XA30/SP SURGICAL LASERS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Flexible Fixation Device for Gynecological Applicators (GM11001960)

FDA 510(k)

FDA Class 2 ·Radiology

MODEL 550-DC CROSSFIRE(TM)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFIED LANDMARK VENOUS ACCESS DEVICE

FDA 510(k)

FDA Class 2 ·General Hospital

LARIAT LOOP APPLICATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

UPSCAN 120

FDA 510(k)

FDA Class 2 ·Radiology

OSSEODENT(R) PRECISION DENTAL ATTACHMENTS

FDA 510(k)

FDA Class 2 ·Dental

THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACCULEVEL THEOPHYLLINE TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

COHERENT XA-30/SP CO2 SURGICAL LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Mould Probe MR Safe

FDA 510(k)

FDA Class 2 ·Radiology

FRAXEL SR LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI)

FDA 510(k)

FDA Class 2 ·Radiology

VARIS 1.4G

FDA 510(k)

FDA Class 2 ·Radiology

LARIAT II SUTURE DELIVERY DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery