TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES

FDA 510(k)

FDA Class 2 ·Orthopedic

MULTIPLE (IZON DNA BLOOD COLLECTION KIT)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTROSURGICAL WANDS

FDA 510(k)

FDA Class 2 ·Orthopedic

AmCAD-UT Detection 2.2

FDA 510(k)

FDA Class 2 ·Radiology

Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107

FDA 510(k)

FDA Class 2 ·General Hospital

L1 SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Haymaker® Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES

FDA 510(k)

FDA Class 2 ·Microbiology

BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Hepatica v1 (Hepatica v1.0.0)

FDA 510(k)

FDA Class 2 ·Radiology

8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital

Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Dillard Airway Dilatation System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ENDOCAM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DynaClipTM Bone Staple

FDA 510(k)

FDA Class 2 ·Orthopedic

INOX THERMOMETER JAR

FDA 510(k)

FDA Class 2 ·General Hospital

Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B

FDA 510(k)

FDA Class 2 ·Cardiovascular

Revogene

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PUMA-G System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology