PLATELETWORKS

FDA 510(k)

FDA Class 2 ·Hematology

BRACHYTHERAPY SOURCE DEVICE, MODEL 9011

FDA 510(k)

FDA Class 2 ·Radiology

DEGOTZEN SYNCHRO

FDA 510(k)

FDA Class 2 ·Dental

VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System

FDA 510(k)

FDA Class 2 ·Orthopedic

COBAS FP REAGENTS FOR QUINIDINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VYGON PREMI-CATH - LONG TERM CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital

COLLAGEN BONE HEALING PROTECTIVE SHEET

FDA 510(k)

FDA Class 2 ·Orthopedic

STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

HUNTLEIGH FLOWPRESS AC300 PUMP, SQ301/302/320 GAR.

FDA 510(k)

FDA Class 2 ·Cardiovascular

ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

OSTEO 4.0MM CANNULATED SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ACCIN PATELLOFEMORAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

VARIAX 2 SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ALTA INTRAMEDULLARY ROD SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

EBI XFIX DFS SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

HOWMEDICA FEMORAL & PROXIMAL TIBIAL MODULAR REPLACEMENT SYTESM

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO OMEGA 21 SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

AZUL PERSONAL LUBRICANT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVANCED AUTOMATIC KV

FDA 510(k)

FDA Class 2 ·Radiology