CLARUS SPINEPEN MODEL 2126

FDA 510(k)

FDA Class 2 ·Neurology

RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HAKIM PROGRAMMER AND TRANSMITTER

FDA 510(k)

FDA Class 2 ·Neurology

KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

InVision™ 1.5 Surgical Theatre

FDA 510(k)

FDA Class 2 ·Radiology

MICROSURGE REUSABLE FRONT END GRASP DEVICES, MODIF

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KALLESTAD SM/RNP TEST REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

X-MESH EXPANDABLE CAGE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

preCARDIA Occlusion System

FDA 510(k)

FDA Class 2 ·Cardiovascular

LEVEEN SUPERSLIM NEEDLE ELECTRODE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACCESS(R) TOTAL T3

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HYPERQ SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

SIGHTFIX

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SmartLinx Vitals Plus Patient Monitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

PK ZIP WING CUTTING DISSECTOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ENVOYCEM, MODEL 1640

FDA 510(k)

FDA Class 2 ·Dental

3M AURORA SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY

FDA 510(k)

FDA Class 2 ·General Hospital