Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TRILOGY TX WITH 3RD PARTY COUCH TOP SUPPORT

FDA 510(k)

FDA Class 2 ·Radiology

Neocis Planning Software Application (NPSA) for 3rd Party PCs

FDA 510(k)

FDA Class 2 ·Dental

SOFT LENS THERMAL DISINFECTING UNIT, A-C

FDA 510(k)

FDA Class 2 ·Ophthalmic

Visualase V2 MRI-guided Laser Ablation System (9736422)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Visualase MRI-Guided Laser Ablation System (SW 3.4)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Monteris Medical NeuroBlate System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TRANBERG Thermoguide Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HEMOCLEAN

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MARTINEZ ORBITAL IMPLANT

FDA 510(k)

FDA Class 2 ·Ophthalmic

TRAP-BLOOD VESSEL STABILIZATION DEVICE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IRIS RETRACTING PHACOEMULSIFICATION SLEEVE

FDA 510(k)

FDA Class 2 ·Ophthalmic

VHS PEDIATRIC HIP SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BLACHLY BITE BLOK & CHEEK FILLER

FDA 510(k)

FDA Class 2 ·Neurology

DESENS-IONOMER

FDA 510(k)

FDA Class 2 ·Dental

POTASSIUM NITRATE POLYCARBOXYLATE DENTAL CEMENT

FDA 510(k)

FDA Class 2 ·Dental

GLASS IONOMER CEMENT

FDA 510(k)

FDA Class 2 ·Dental

VARI-ANGLE HIP SCREW (VHS) SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

INNERVISION IRRIGATION PUMP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology