ORTHOPEDIATRICS BONE SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

VITAL-PORT INFUSION PAL

FDA 510(k)

FDA Class 2 ·General Hospital

Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP

FDA 510(k)

FDA Class 2 ·Immunology

ENHANCED MODULAR AUSTIN MOORE HIP

FDA 510(k)

FDA Class 2 ·Orthopedic

SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PANORAMIC CORPORATION HDLX

FDA 510(k)

FDA Class 2 ·Radiology

NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cable-Ready Cable Grip System: Cable-Ready Bone Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

SUMMIT DUOFIX HIP PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

FLIPPER DETACHABLE EMBOLIZATION COILS

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODULAR HYBRID GLENOID

FDA 510(k)

FDA Class 2 ·Orthopedic

PHASE 2 TRANSCRANIAL PROBE

FDA 510(k)

FDA Class 2 ·Radiology

InCore TMT System

FDA 510(k)

FDA Class 2 ·Orthopedic

V-MARC 88A COMPUTER

FDA 510(k)

FDA Class 2 ·Hematology

TEMPFIX EXTERNAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

VAN-TEC BLADDER EVACUATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DEPUY ATTUNE TOTAL KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

GLUMA 3 STEP BONDING SYSTEM/ GLUMA 3 PRIMER/DESENSITIZER

FDA 510(k)

FDA Class 2 ·Dental