TSI; ERI

FDA 510(k)

FDA Class 2 ·Dental

ERIE-NEB

FDA 510(k)

FDA Class 2 ·Anesthesiology

ERIS LAYERING MATERIALS

FDA 510(k)

FDA Class 2 ·Dental

QLAB Advanced Quantification Software

FDA 510(k)

FDA Class 2 ·Radiology

DRI-STAT ACID PHOSPHATASE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ERI-FLO 900 DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ERIS URO-DIAGNOSTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TRACHEAL TUBES

FDA 510(k)

FDA Class 2 ·Anesthesiology

TRACHEAL TUBE 16 GAUGE-1.65MM-

FDA 510(k)

FDA Class 2 ·Anesthesiology

ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)

FDA 510(k)

FDA Class 2 ·Radiology

CATHETER WITHDRAWAL UNIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FILLING VOLUME OPTION

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PAS LACROSSE TM PTCA CATHETER

ERI Handheld Dental X-ray System (Model AG100)

FDA 510(k)

FDA Class 2 ·Dental

VERTEX SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANKYLOS DENTAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

FRIALIT-2 MH-2 ABUTMENT

FDA 510(k)

FDA Class 2 ·Dental

NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000

FDA 510(k)

FDA Class 2 ·Ophthalmic