THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

SPIN-LOC SUTURE ANCHOR SYSTEM FG-0302-01,FG-0305-01

FDA 510(k)

FDA Class 2 ·Orthopedic

TAPER-22 STEERABLE GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

InVision Precision LVEF (LVEF)

FDA 510(k)

FDA Class 2 ·Radiology

IMMULITE VITAMIN B12 (LKVB1,LKVB5)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

WHEEL-CHAIR W/MOTOR DRIVE

FDA 510(k)

FDA Class 2 ·Physical Medicine

Surgikor Fixation One, Abutment Blanks and Abutments

FDA 510(k)

FDA Class 2 ·Dental

IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6

FDA 510(k)

FDA Class 2 ·Microbiology

Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers

FDA 510(k)

FDA Class 2 ·Radiology

MODEL 20-C W/SA-20A/U OPTICAL ATTACHMENT/SURG USE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

NU-CATH EMERGENCY KIT

FDA 510(k)

FDA Class 2 ·General Hospital

IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ADD MIX ALLERGEN PANEL MOD ALASTAT(R) ALLERGEN IGE

FDA 510(k)

FDA Class 2 ·Immunology

LABELING CHANGE COAT-A-COUNT COCAINE METABOLITE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT

FDA 510(k)

FDA Class 2 ·Hematology