ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS

FDA 510(k)

FDA Class 2 ·Immunology

SUTURE WELDING SYSTEM AND KIT (SWK)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

DUALSCREEN

FDA 510(k)

FDA Class 2 ·Neurology

MENTOR WET-FIELD*II COAGULATOR

FDA 510(k)

FDA Class 2 ·Ophthalmic

R&D BATTEERIES, INC. PART NUMBERS 5173, 5178, 5197 AND 5199

FDA 510(k)

FDA Class 2 ·General Hospital

TCX-I REMOTE CARE MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Spring Coil Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

Aina HbA1c Monitoring System 2

FDA 510(k)

FDA Class 2 ·Hematology

Qmenta Care Platform Family

FDA 510(k)

FDA Class 2 ·Radiology

Stingray LP Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ARDIS INTERBODY SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ULTIMUM EV HEMOSTASIS INTRODUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ETCHING GEL

FDA 510(k)

FDA Class 2 ·Dental

CorPath 200 System

FDA 510(k)

FDA Class 2 ·Cardiovascular

REPROCESSED LASER PROBE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Imbio Segmentation Editing Tool software

FDA 510(k)

FDA Class 2 ·Radiology

QLAB Advanced Quantification Software

FDA 510(k)

FDA Class 2 ·Radiology