Suture, Nonabsorbable

FDA Pre-Market Approval

FDA Class 2 ·MERSILENE*POLYESTER SUTURE

Probe Covers (YF-001, YF-002)

FDA 510(k)

FDA Class 2 ·General Hospital

External Counterpulsation System

FDA 510(k)

FDA Class 2 ·Cardiovascular

TENS & PMS Unit

FDA 510(k)

FDA Class 2 ·Neurology

Air Compression Leg Massager (K-705)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Air Smart Extra Spirometer

FDA 510(k)

FDA Class 2 ·Anesthesiology

Disposable Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PHILIPS MULTIDIAGNOST ELEVA

FDA 510(k)

FDA Class 2 ·Radiology

K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03)

FDA 510(k)

FDA Class 2 ·General Hospital

Ultraviolet Phototherapy Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312

FDA 510(k)

FDA Class 2 ·Cardiovascular

IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Infrared Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

CALCIUM REAGENT SYS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS HCV TEST

NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

ACUVANCE PLUS SAFETY IV CATHETER, PROTECTIV PLUS SAFETY IV CATHETER, OPTIVA IV CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital