GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL

FDA 510(k)

FDA Class 2 ·Microbiology

HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ECHOENCODER

FDA 510(k)

FDA Class 2 ·Radiology

RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA

FDA 510(k)

FDA Class 2 ·Hematology

CONTOUR II SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

HEM-O-LOK LIGATING CLIP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EVOL® ha-C Cervical Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

DX-D IMAGING PACKAGE

FDA 510(k)

FDA Class 2 ·Radiology

WILOSN-COOK BILIARY DILATION BALLOON

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COAG-A-MATE MAX

FDA 510(k)

FDA Class 2 ·Hematology

FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211

FDA 510(k)

FDA Class 2 ·Cardiovascular

VANTERA CLINICAL ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DELTA

FDA 510(k)

FDA Class 2 ·General Hospital

RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR LATEX TEST

FDA 510(k)

FDA Class 2 ·Immunology

SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty

FDA 510(k)

FDA Class 2 ·Orthopedic

HEMOCLIP X-20 AUTOMATIC HEMOCLIP LIGATING APPLIER

FDA 510(k)

FDA Class 2 ·Microbiology

QuikClot Control+ Hemostatic Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

UROLOGICAL CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology