Balloon Inflation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

FDA 510(k)

FDA Class 2 ·Dental

IPL Hair Removal Device (BE965A, BE965B, BE965C)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IPL Hair Removal Device (BE932C, BE932D, BE932E)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SHIAN JIA MEEI DIGATAL PWN TENS, MODEL YW-6000/UC-332/UC-330/ST-331

FDA 510(k)

FDA Class 2 ·Neurology

Medical Surgical Mask (Model: JM92, JM92B)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Models 2200DR and 1600DR Digital Stationary Radiographic Systems

FDA 510(k)

FDA Class 2 ·Radiology

2-in-1 Abdominal Muscle Training & Back Pain Relief System

FDA 510(k)

FDA Class 2 ·Neurology

Handheld VitalSigns Monitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)

FDA 510(k)

FDA Class 2 ·General Hospital

GALEMED PEAK FLOW METER, MODELS 3751/3752

FDA 510(k)

FDA Class 2 ·Anesthesiology

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ST AIA-PACK PA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·AIA PACK PA

AIA-PACK BRCA, ST AIA PACK BRCA

FDA 510(k)

FDA Class 2 ·Immunology

ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AIA-PACK FT4

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AIA-PACK BMG

FDA 510(k)

FDA Class 2 ·Immunology

AIA-PACK T4

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ZOLL PROPAQ M

FDA 510(k)

FDA Class 2 ·Cardiovascular

ZOLL AUTOCLAVABLE INTERNAL HANDLES

FDA 510(k)

FDA Class 2 ·Cardiovascular