Vantage PSI System

FDA 510(k)

FDA Class 2 ·Orthopedic

VeriFixx™ Small Bone Implant

FDA 510(k)

FDA Class 2 ·Orthopedic

Apex 3D Total Ankle Replacement System

FDA 510(k)

FDA Class 2 ·Orthopedic

COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

SURGICAL INSTRUMENT POUCH #M102

FDA 510(k)

FDA Class 2 ·General Hospital

STREAM-SWITCH MANIFOLD

FDA 510(k)

FDA Class 2 ·General Hospital

FLXFIT INTERVERTEBRAL BODY FUSION DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS

FDA 510(k)

FDA Class 2 ·Anesthesiology

iMap 3D Mapping & Navigation System (iMap System)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Grappler Interference Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

BIA / VITALITY ANALYZER

FDA 510(k)

FDA Class 2 ·Cardiovascular

TDS Standard Solution

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DYNA INTRA-LIMBAL LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

MODIFICATION TO: LANX SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

DERMILLUME, MODEL PRO1000

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HEPCON HMS WITH BODY SURFACE AREA CALCULATION

FDA 510(k)

FDA Class 2 ·Hematology

Rapid Neuro3D

FDA 510(k)

FDA Class 2 ·Radiology

INTELLIJECT INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology