Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Dimension TPSA Flex reagent cartridge (RF451)

BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel

FDA 510(k)

FDA Class 2 ·Microbiology

TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System

FDA 510(k)

FDA Class 2 ·Orthopedic

MICRO-MAX, MODEL 319

FDA 510(k)

FDA Class 2 ·Radiology

BD MAX Vaginal Panel

FDA 510(k)

FDA Class 2 ·Microbiology

GE MR MAX SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

MAX-1 (EXERCISE ELECTROCARDIOGRAPH)

FDA 510(k)

FDA Class 2 ·Cardiovascular

EZFLOW MAX, MODEL 1007

FDA 510(k)

FDA Class 2 ·Anesthesiology

AcQGuide MAX Steerable Sheath

FDA 510(k)

FDA Class 2 ·Cardiovascular

I-MAX TOUCH 3D

FDA 510(k)

FDA Class 2 ·Radiology

MAX 02 OXYGEN CONCENTRATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

OMNI~NEB; OMNI~MAX

FDA 510(k)

FDA Class 2 ·Anesthesiology

DESTINY MAX COAGULATION ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

STRYKER ORAL MAX SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

GE MR MAX SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

SENDERO MAX Delivery Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

TI-MAX PROTRUSIO CAGE

FDA 510(k)

FDA Class 2 ·Orthopedic

PLANMECA PROMAX 3D MAX

FDA 510(k)

FDA Class 2 ·Dental

OMNIPULSE-MAX HOLMIUM LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TANDA MAX OTC SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery