HAAG-STREIT FUNDUS MODULE 300

FDA 510(k)

FDA Class 2 ·Ophthalmic

ICAM FUNDUS CAMERA

FDA 510(k)

FDA Class 2 ·Ophthalmic

MANGAR BOOSTER

FDA 510(k)

FDA Class 2 ·General Hospital

BOMDAL STANDARD LIFT

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFICATION TO KOWA NONMYD ALPHA-DIII

FDA 510(k)

FDA Class 2 ·Ophthalmic

ISCREEN VISION SCREENER

FDA 510(k)

FDA Class 2 ·Ophthalmic

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS CONCORDE CORONARY DILATATION CATHETER (QUARTER SIZE DIAMETER 30MM AND 40MM BALLON LENGTHS)

Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

GLOBAL ICON Stemless Shoulder System

FDA 510(k)

FDA Class 2 ·Orthopedic

VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120

FDA 510(k)

FDA Class 2 ·Anesthesiology

RANDOX C-REACTIVE PROTEIN

FDA 510(k)

FDA Class 2 ·Immunology

PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

RANDOX LIQUID PROTEIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RANDOX CALCIUM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITALOGRAPH MODEL 7000 SPIROTRAC

FDA 510(k)

FDA Class 2 ·Anesthesiology

RANDOX ALBUMIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS

FDA 510(k)

FDA Class 2 ·Neurology

RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

Delta Xtend Reverse Shoulder System

FDA 510(k)

FDA Class 2 ·Orthopedic

RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology