Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators

FDA 510(k)

FDA Class 2 ·General Hospital

Safe Secure Sterilization Pouches and Rolls

FDA 510(k)

FDA Class 2 ·General Hospital

IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS

FDA 510(k)

FDA Class 2 ·Radiology

Handheld Pulse Oximeter, Model SP-20

FDA 510(k)

FDA Class 2 ·Cardiovascular

PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement

FDA 510(k)

FDA Class 2 ·Dental

MANTIS Clip

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CO2 Laser Machine, Model: BW-203B

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Diode Laser Machine, Model Number: BM-100

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000

FDA 510(k)

FDA Class 2 ·Radiology

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

KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530

FDA 510(k)

FDA Class 2 ·Cardiovascular

AQUAMAX (POLYMACON) DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES

FDA 510(k)

FDA Class 2 ·Ophthalmic

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

EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

MICRO HAEMATOCRIT CENTRIFUGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EchoConfidence (USA)

FDA 510(k)

FDA Class 2 ·Radiology

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