FLU-VEN TK-2

FDA 510(k)

FDA Class 2 ·Hematology

KAWASUMI LABORATORY BLOOD DRAWING KIT

FDA 510(k)

FDA Class 2 ·Hematology

Kawasumi Laboratories Blood Drawing Kit (BDK) System

FDA 510(k)

FDA Class 2 ·Hematology

SUPER-SPIKE TRANSFER SET

FDA 510(k)

FDA Class 2 ·Hematology

ALPHA PLASMA TRANSFER SET

FDA 510(k)

FDA Class 2 ·Hematology

FLU VEN TR-1

FDA 510(k)

FDA Class 2 ·Hematology

SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Set, Transfer (Blood/Plasma)

FDA classification

FDA Class 2 ·Set, Transfer (Blood/Plasma)

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·ATA SOFTWARE CARTRIDGE (SWM 1000 I-KTB.0.U)

Disposable Procedural Ear-loop Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CFR QUANT

FDA 510(k)

FDA Class 2 ·Radiology

HeartSee

FDA 510(k)

FDA Class 2 ·Radiology

ESB 2400 SEI

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

REMOTE FETAL MEDICINE ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17

FDA 510(k)

FDA Class 2 ·Radiology

BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES

FDA 510(k)

FDA Class 2 ·Cardiovascular

VTU-E VACUUM ERECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TRANSCOM COLON HYDROTHERAPY MODEL HC-2000

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ORIGINAL REGULAR TAMPAX TAMPONS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CALCITONIN KIT MITSUBISHI YUKA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry