SPI Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

Torpedo Gelatin Foam

FDA 510(k)

FDA Class 2 ·Cardiovascular

Infinity™ OCT System and PASS OCT Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

Senographe Pristina

FDA 510(k)

FDA Class 2 ·Radiology

Carefusion NeutraClear Needle-free connector (EL-NC1000)

FDA 510(k)

FDA Class 2 ·General Hospital

LINACwatch, LinacView

FDA 510(k)

FDA Class 2 ·Radiology

TRAY ADAPTERS, MULTIPLE

FDA 510(k)

FDA Class 2 ·Radiology

OPTICAL FRAMES & SUNGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM; AEQUALIS SHOULDER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

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