ABX PENTRA MICRO ALB CONTROL L/H

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Mallya Injection Pen Adapter (Mallya® for Solostar®)

FDA 510(k)

FDA Class 2 ·General Hospital

Cellvizio 100 series system with confocal Miniprobes

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ABX PENTRA 400 : CRP

FDA 510(k)

FDA Class 2 ·Immunology

Withings Scan Monitor 2.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

deepLive

FDA 510(k)

FDA Class 2 ·Radiology

PASS LP™ Spinal System, CD Horizon™ Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

JARVIS Glenoid Reverse Shoulder Prosthesis

FDA 510(k)

FDA Class 2 ·Orthopedic

URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER

FDA 510(k)

FDA Unclassified ·Unknown

Newclip Patient-matched instrumentation non sterile PSI

FDA 510(k)

FDA Class 2 ·Orthopedic

PASS OCT Patient Specific Rods

FDA 510(k)

FDA Class 2 ·Orthopedic

Yumizen C1200 CRP

FDA 510(k)

FDA Class 2 ·Immunology

DIP Arthrodesis System

FDA 510(k)

FDA Class 2 ·Orthopedic

Anthogyr Surgical Cassettes

FDA 510(k)

FDA Class 2 ·General Hospital

AXIOM REG

FDA 510(k)

FDA Class 2 ·Dental

ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ChestView US

FDA 510(k)

FDA Class 2 ·Radiology

Versatex Monofilament Mesh

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

JAZZ System, including JAZZ Band

FDA 510(k)

FDA Class 2 ·Orthopedic