RADS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Holter ECG and ABP System

FDA 510(k)

FDA Class 2 ·Cardiovascular

vital signs monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Acclarix AX4 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Electrocardiograph

FDA 510(k)

FDA Class 2 ·Cardiovascular

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Intense Pulse Light Therapeutic Apparatus

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Patient Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

IPL Hair Removal Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Electrocardiograph: SE-1200 Pro and SE-1201 Pro

FDA 510(k)

FDA Class 2 ·Cardiovascular

Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology