ECHO Photocoagulator

FDA 510(k)

FDA Class 2 ·Ophthalmic

Abutment Design

FDA 510(k)

FDA Class 2 ·Dental

Tinnitus Sound Generator Module

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Ultrasound System 2300

FDA 510(k)

FDA Class 2 ·Radiology

FBC 921 (ALIF)

FDA 510(k)

FDA Class 2 ·Orthopedic

Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Ultrasound Scanner System bk2300

FDA 510(k)

FDA Class 2 ·Radiology

ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABL837 FLEX ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Elos Accurate Hybrid Base

FDA 510(k)

FDA Class 2 ·Dental

MODEL DPS-4050 DIGITAL RADIOGRAPHY SYSTEM

FDA 510(k)

ELLIPSE LIGHT SPT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava Filter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ITC HEARING AID CLUB MODEL LM40

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert

FDA 510(k)

FDA Class 2 ·Radiology

CORTEX DERMASCAN C ULTRASONIC SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator

FDA 510(k)

FDA Class 2 ·Anesthesiology

Ambu aScope 4 Cysto

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CHEMPAQ XBC ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology