Hand-held IPL device (JOVS Hair Removal Device)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EFH-16; S60-K; S 60-J; S 60-S

ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM

FDA 510(k)

FDA Class 2 ·Dental

ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER

FDA 510(k)

FDA Class 2 ·Orthopedic

Arthrex iBalance Partial Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MAKO SURGICAL UNICONDYLAR KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MOD-ML UNICOMPARTMENTAL KNEE PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

STELKAST UNICONDYLAR KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACE

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

GEO-TIBIAL RETAINER ROTATIONAL

FDA 510(k)

FDA Class 2 ·Orthopedic

CONCEPT UNICOMPARTMENTAL KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

EIUS UNICOMPARTMENTAL KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

PRESERVATION UNICOMPARTMENTAL KNEE

FDA 510(k)

FDA Class 2 ·Orthopedic

SYNATOMIC STANDARD TIBIAL PLATEAU

FDA 510(k)

FDA Class 2 ·Orthopedic

Materialise PKA Guide System

FDA 510(k)

FDA Class 2 ·Orthopedic

HLS UNI EVOLUTION & U-KNEETEC

FDA 510(k)

FDA Class 2 ·Orthopedic

ZIMMER UNICOMPARTMENTAL KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic