E1000 Dx Digital Pathology Solution

FDA 510(k)

FDA Class 2 ·Pathology

SATURN ACTIVE LASER SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

RI Witness Embryology Heated Plate

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OSTEOTEC SILICONE FINGER IMPLANT

FDA 510(k)

FDA Class 2 ·Orthopedic

ORTHOVIEW

FDA 510(k)

FDA Class 2 ·Radiology

EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

THERMO TEK IR FOREHEAD THERMOMETER, MODEL 718F

FDA 510(k)

FDA Class 2 ·General Hospital

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·BELOS VR-T ICD

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD'S)

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·TEROX RV /KAINOX SL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR/LEAD MODELS

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·BELOS VR ICD SYSTEM

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·BELOS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·KENTROX RV-S/KENTROX SL-S ICD LEADS

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·KENTROX RV LEAD SYSTEMS

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

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

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

ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·cobas CMV Test for use on the cobas 6800/8800 System