ARTERIAL EMBOLECTOMY CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRUITT EMBOLECTOMY/IRRIGATION CATHETER (MODIFIED)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Cold Compression Wrap Pro

FDA 510(k)

FDA Class 2 ·Physical Medicine

Hand-held IPL device(JOVS Graphene Hair Removal Device)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TYSONBIO LINK HEALTH MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIACHEX BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Strabismus Detection Device

FDA classification

FDA Class 2 ·Strabismus Detection Device

308nm Excimer System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

308nm Excimer System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Irradiation Aesthetic Device

FDA 510(k)

FDA Class 2 ·Physical Medicine

Irradiation Cosmetic Device

FDA 510(k)

FDA Class 2 ·Physical Medicine

Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Catheter, Embolectomy

FDA classification

FDA Class 2 ·Catheter, Embolectomy