RI-MED

FDA 510(k)

FDA Class 2 ·Cardiovascular

GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating

FDA 510(k)

FDA Class 2 ·Orthopedic

VITA ENAMIC Implant Solutions (IS)

FDA 510(k)

FDA Class 2 ·Dental

Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories

FDA 510(k)

FDA Class 2 ·Neurology

AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

Power Wheelchair

FDA 510(k)

FDA Class 2 ·Physical Medicine

Universal Mesh - Sterile

FDA 510(k)

FDA Class 2 ·Neurology

BiMobile Instruments (for BiMobile Dual Mobility System)

FDA 510(k)

FDA Class 2 ·Orthopedic

OSTEOPAL

FDA 510(k)

FDA Class 2 ·Orthopedic

INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, MP80, MP90

FDA 510(k)

FDA Class 2 ·Cardiovascular

ASTHMA MONITOR AM2

FDA 510(k)

FDA Class 2 ·Anesthesiology

PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15)

FDA 510(k)

FDA Class 2 ·Dental

ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PHILIPS INTELLIVUE TCG10

FDA 510(k)

FDA Class 2 ·Anesthesiology

ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

LIPOSAT BASIC (INFILTRATION PUMP), MODEL 92-007 688

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PALABOND

FDA 510(k)

FDA Class 2 ·Orthopedic

PHILIPS AVALON FETAL MONITORS FM20 AND FM30

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface

FDA 510(k)

FDA Class 2 ·Orthopedic