SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045

FDA 510(k)

FDA Class 2 ·Cardiovascular

N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

GE PRECISION MPI

FDA 510(k)

FDA Class 2 ·Radiology

SafeAir combi (SFR-combi-US)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FlashHeal 2 (FlashHeal 2.0)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TITAN

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set

FDA 510(k)

FDA Class 2 ·General Hospital

PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202

FDA 510(k)

FDA Class 2 ·Radiology

ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ABL90 FLEX

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Elos Accurate® Customized Abutment

FDA 510(k)

FDA Class 2 ·Dental

TCL3 Motion Tracking System

FDA 510(k)

FDA Class 2 ·Radiology

ECGenius System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ultrasound System 1300

FDA 510(k)

FDA Class 2 ·Radiology

SwimCount Sperm Quality Test

FDA 510(k)

FDA Class 2 ·Hematology

AUTOMOVE, MODEL AM800

FDA 510(k)

FDA Class 2 ·Physical Medicine

LUNDERQUIST WIRE GUIDE; DC WIRE GUIDE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ultrasound System 1300

FDA 510(k)

FDA Class 2 ·Radiology

EmbryoScope+

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology