HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, HHS-MAX-N

FDA 510(k)

FDA Class 2 ·Cardiovascular

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·artus CMV RGQ MDx Kit and artus CMV QS-RGQ MDx Kit

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·artus CMV RGQ MDx Kit and artus CMV QS-RGO MDx Kit

TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

BD MAX(TM) ENTERIC BACTERIAL PANEL;BD MAX(TM) INSTRUMENT

FDA 510(k)

FDA Class 2 ·Microbiology

VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

THYROID MICROSOMAL ANTIGEN AUTO-ANTIBODY ENZYME

FDA 510(k)

FDA Class 2 ·Immunology

EC50 MICRO+ SMOKERLYZER

FDA 510(k)

FDA Class 2 ·Anesthesiology

INTEGRITY, MODEL V500

FDA 510(k)

FDA Class 2 ·Neurology

THYROGLOBULIN AUTO-ANTIBODY EIA TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

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