HemoSphere Advanced Monitor, HemoSphere ClearSight Module

FDA 510(k)

FDA Class 2 ·Cardiovascular

Theranos Herpes Simplex Virus-1 IgG Assay

FDA 510(k)

FDA Class 2 ·Microbiology

Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System

FDA 510(k)

FDA Class 2 ·Orthopedic

Smith & Nephew Patient Matched Cutting Blocks

FDA 510(k)

FDA Class 2 ·Orthopedic

Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AMS MINIARC SLING SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

JOURNEY II Uni Tibial Base and Insert

FDA 510(k)

FDA Class 2 ·Orthopedic

THERAPEUTIC MASSAGE COMPANION

FDA 510(k)

FDA Class 2 ·Neurology

Athena 190

FDA 510(k)

FDA Class 1 ·Physical Medicine

ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert

FDA 510(k)

FDA Class 2 ·Orthopedic

BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S

FDA 510(k)

FDA Class 2 ·Orthopedic

POLARSTEM Cemented Femoral Stem

FDA 510(k)

FDA Class 2 ·Orthopedic

AMS SINGLE INCISION SLING SYSTEM (SIS-0)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System

FDA 510(k)

FDA Class 2 ·Cardiovascular

CD HORIZON SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, MODEL 7.3MM

FDA 510(k)

FDA Class 2 ·Orthopedic

IMTEC SENDAX MDI ORTHO6 AND ORTHO8

FDA 510(k)

FDA Class 2 ·Dental

Porous Patella and Porous Tibia Baseplate

FDA 510(k)

FDA Class 2 ·Orthopedic

CD HORIZON SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic