Dynamic TiBase; TRI Screws

FDA 510(k)

FDA Class 2 ·Dental

QP-Prostate® CAD

FDA 510(k)

FDA Class 2 ·Radiology

Enobio Wireless EEG

FDA 510(k)

FDA Class 2 ·Neurology

FLIX-EMS

FDA 510(k)

FDA Class 2 ·Physical Medicine

ECG recorder and Arrhythmia Detector

FDA 510(k)

FDA Class 2 ·Cardiovascular

Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System

FDA 510(k)

FDA Class 2 ·Neurology

QNext and DG-PT

FDA 510(k)

FDA Class 2 ·Hematology

ARiX RAD Radiographic System

FDA 510(k)

FDA Class 2 ·Radiology

Zionic Pro Max (Radiofrequency)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IFA SENSIBAC CEFACLOR

FDA 510(k)

FDA Class 2 ·Microbiology

BOBES SLIT LAMP

FDA 510(k)

FDA Class 2 ·Ophthalmic

DOSI FLOW

FDA 510(k)

FDA Class 2 ·General Hospital

MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X (1,3 OR 6 STRIPS PER BOX)

FDA 510(k)

FDA Class 2 ·Orthopedic

WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·QVCAD System (Version 3.3)

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·QVCAD SYSTEM

SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068)

FDA 510(k)

FDA Class 2 ·Dental