FACTOR II (PROTHROMBIN) G20210A KIT

FDA 510(k)

FDA Class 2 ·Hematology

ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II

FDA 510(k)

FDA Class 2 ·Hematology

XPERT HEMOSIL FACTOR II & FACTOR V ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

Xpert® FII & FV

FDA 510(k)

FDA Class 2 ·Hematology

SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER

FDA 510(k)

FDA Class 2 ·General Hospital

Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK

FDA 510(k)

FDA Class 2 ·Cardiovascular

SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

Wireless Smart Gluco-Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT

FDA 510(k)

FDA Class 2 ·Dental

Tisuthes e-PTFE Surgical Patch

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

TEMPFX ESTHETIC PROVISIONAL SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

SOLCOTRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

HI TORQUE CONNECT GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

CONNECTED CARE CLINICAL APPLICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLEXMEDICS MALLEABLE CANNULA

FDA 510(k)

FDA Class 2 ·Orthopedic