PULPDENT VLC RESIN CEMENT

FDA 510(k)

FDA Class 2 ·Dental

Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable

FDA 510(k)

FDA Class 2 ·Neurology

DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01

FDA 510(k)

FDA Class 2 ·Cardiovascular

M2376A DEVICELINK SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

STOCKERT S3 DOUBLE HEAD PUMP MODULE

FDA 510(k)

FDA Class 2 ·Cardiovascular

BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER

FDA 510(k)

FDA Class 2 ·Orthopedic

BICONITE SURFACE TREATMENT

FDA 510(k)

FDA Class 2 ·Dental

STRATO/INFUSAIF INFUSE-A-CATH CENTRAL VENOUS CATHETERS

FDA 510(k)

FDA Class 2 ·General Hospital

iTotal® Hip Replacement System

FDA 510(k)

FDA Class 2 ·Orthopedic

SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

PERCUFIX CATHETER CUFF

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Low Ejection Fraction AI-ECG Algorithm

FDA 510(k)

FDA Class 2 ·Cardiovascular

SurgiMend PRS Meshed, Revize-X

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Interject Injection Therapy Needle Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MILAGRO INTERFERENCE SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MICROVASIVE BALLOON GASTROSTOMY TUBE KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FLEXIBLE CYSTOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology