DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

Contact Lens Case, Model: A-1, B-1

FDA 510(k)

FDA Class 2 ·Ophthalmic

Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MICRO HAEMATOCRIT CENTRIFUGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Laser Therapy Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)

FDA 510(k)

FDA Class 2 ·Dental

Mjolnir Pro. (Multi–electrode plasma)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LED Therapy Device (Planar LED/Planar LED mini)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Planar LED mate

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

FDA 510(k)

FDA Class 2 ·Neurology

Leaf Smooth

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KAY-PLUS & VARIOUS VANIA SANITARY LINERS & PADS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Models 2200DR and 1600DR Digital Stationary Radiographic Systems

FDA 510(k)

FDA Class 2 ·Radiology

MONOLIFT MPE2, PLATFORM, CHAIR, FULLY FUTO PLATFOR

FDA 510(k)

FDA Class 2 ·Physical Medicine

LIGTVOET L80.2 LIGHTFOOT L80.2 POWER WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

MFE COUCH ERGOMETER

FDA 510(k)

FDA Class 2 ·Physical Medicine