AUROLITE CB25

FDA 510(k)

FDA Class 2 ·Dental

AURIUM 20% (LOW GOLD CROWN AND BRIDGE ALLOY)

FDA 510(k)

FDA Class 2 ·Dental

AURIUM D17 (HIGH GOLD CROWN & BRIDGE ALLOY)

FDA 510(k)

FDA Class 2 ·Dental

Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AUROLITE 1C

FDA 510(k)

FDA Class 2 ·Dental

CBC-CAL/MULTIPLE

FDA 510(k)

FDA Class 2 ·Hematology

HEMATOLOGY CALIBRATOR S-CAL

FDA 510(k)

FDA Class 2 ·Hematology

TECH-CAL(TM)/MULTIPLE

FDA 510(k)

FDA Class 2 ·Hematology

TRI-COUNT CALIBRATOR

FDA 510(k)

FDA Class 2 ·Hematology

SCS-1000 (SYSMEX CALIBRATOR SYSTEM)

FDA 510(k)

FDA Class 2 ·Hematology

HEMOTOLOGY CALIBRATOR

FDA 510(k)

FDA Class 2 ·Hematology

CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE

FDA 510(k)

FDA Class 2 ·Hematology

H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS

FDA 510(k)

FDA Class 2 ·Hematology

POWDER FREE SURGEON'S GLOVE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OBTURATOR, DEFLECTING

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OBTURATOR, VISUAL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CHISELS- FREER, LUCAS, ALEXANDER, BISHOP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INTRODUCER SHEATH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EchoSolv AS

FDA 510(k)

FDA Class 2 ·Radiology

AISAP Cardio V1.0

FDA 510(k)

FDA Class 2 ·Radiology