Dental Diode Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-1050

FDA 510(k)

FDA Class 2 ·Cardiovascular

MYKRES SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Human IgA liquid reagent kit for Use on SPAPlus

FDA 510(k)

FDA Class 2 ·Immunology

BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SLT Select Fiber Delivery System and Contact Tips (models: SSRH 8-SMA; TCRH 7-SMA; FEF 2.2-SMA; CFE 0.6-SMA; SSRH 8Z-SMA; SSRH 4-SMA; SSRH 6-SMA; SSRH 9-SMA; SSRH 10-SMA; SSRH 11-SMA; SSRH 7L-SMA; TCRH 7Z-SMA; FEF 1.8-SMA; CFE 0.55-SMA; CFE 0.36-SMA; LAL 550-SMA; LAL 550Z-SMA; LAL 365-SMA; LAL 365Z-SMA; ER2; ERP2; GR2; GRP2; ER4; ERP4; GR4; GRP4; ER6; ERP6; GR6; GRP6; ER8; ERP8; GR8; GRP8; ER10; ERP10; GR10; GRP10; ER12; ERP12; GR12; GRP12; MD2.5; MD3.5; HP1.0; MTP1.5; MTP3.5; MTRG1.5;

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Fluorescence Mode

FDA 510(k)

FDA Class 2 ·Dental

Medical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SPHYGMOMANOMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

LATEX CONDOMS (NATURAL COLOUR)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

M1 Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CONDOM (RUBBER) CONTRACEPTIVE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Safety Push Button Blood Collection Set

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)

FDA 510(k)

FDA Class 2 ·General Hospital

NAMTAI

FDA 510(k)

FDA Class 2 ·Cardiovascular

Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor, Model Name:W202, Wrist Blood Pressure Monitor, Model Name:W1681

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Easycess Aspiration Pump

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery