ShockPulse-SE Lithotripsy System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LifeSPARC System

FDA 510(k)

FDA Class 2 ·Cardiovascular

activL® Next Generation Instrumentation

FDA 510(k)

FDA Class 2 ·Orthopedic

PLATELET AGGREGATION PROFILER MODEL PAP-4C

FDA 510(k)

FDA Class 2 ·Hematology

SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

XPAND RADIOLUCENT CORPECTOMY SPACER

FDA 510(k)

FDA Class 2 ·Orthopedic

Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI))

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SYNTHES CERVIFIX SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CryOmega Flexx

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA.

FDA 510(k)

FDA Class 2 ·Anesthesiology

ULTRACROWN(TM) PD DENTAL ALLOY

FDA 510(k)

FDA Class 2 ·Dental

KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

WALLABY 4

FDA 510(k)

FDA Class 2 ·General Hospital

IGROK

FDA 510(k)

FDA Class 2 ·Radiology

Nipro Dry Complete Dry Acid Concentrate for Hemodialysis

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ULTRASONIC SURGICAL UNIT

FDA 510(k)

FDA Class 2 ·Dental

ENDOEYE HD II

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR SW VC21

FDA 510(k)

FDA Class 2 ·Radiology

EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic