Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·KAINOX RV-S/ KAINOX VCS ICD LEADS

Pulse-Generator, Pacemaker, External

FDA Pre-Market Approval

FDA Class 2 ·MODEL4553 MICRO-PACE,DUAL-CHAMBER,DDD TEMPORARY CARDIAC PACEMAKER

Pulse-Generator, Pacemaker, External

FDA Pre-Market Approval

FDA Class 2 ·BEDSIDE(TM) SINGLE CHAMBER, TXTERNAL PULSE GENERATOR, MODEL 4170

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·KENTROX RV 65, KENTROX RV 75, KAINOX SL 65/13, KAINOX SL 65/18

PCI 2500

FDA 510(k)

FDA Class 2 ·Physical Medicine

Circulating Tumor Cell (Ctc) Enrichment Device

FDA classification

FDA Class 2 ·Circulating Tumor Cell (Ctc) Enrichment Device

Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration

FDA classification

FDA Class 2 ·Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration

Complement C3b Activator, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Complement C3b Activator, Antigen, Antiserum, Control

Reservoir, Blood, Cardiopulmonary Bypass, Exempt

FDA classification

FDA Class 2 ·Reservoir, Blood, Cardiopulmonary Bypass, Exempt

TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE

FDA 510(k)

FDA Class 2 ·Anesthesiology

SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TRIA FANP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

JETLITE

FDA 510(k)

FDA Class 2 ·Dental

CEFOTAXIME 30 MCG. SENSI-DISC.

FDA 510(k)

FDA Class 2 ·Microbiology

CARDIOTRACE-I TRANSTELEPHONIC ECG RECEIV CONSOLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRINCETON BIOMEDIX HEXOKINASE, GLUCOSE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ASAHI AM SERIES DIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DEEPVISON

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology