KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TREACE DRILL SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DEFIBRILLATOR ANALYZER - DA-2006P

FDA 510(k)

FDA Class 2 ·Cardiovascular

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI APOLLO RELY SP OVER-THE-WIRE BALLOON DILATATION CATHETER WITH HYDRO/PEL COATING AND MINIQUET DEVICE

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R)TELESCOPE(TM) SINGLE OPERATOR BALLOON

UVATAN INDUS. UVATAN 900C, 900B/800 & 600C

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO STAXX FX SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

TRYPTIK2C-plate Anterior Cervical Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

ROMEO 2 PAD POSTERIOR AXIAL DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

JULIET OL

FDA 510(k)

FDA Class 2 ·Orthopedic

JULIET LL

FDA 510(k)

FDA Class 2 ·Orthopedic

Perla Posterior Cervico-Thoracic Fixation system

FDA 510(k)

FDA Class 2 ·Orthopedic

Romeo posterior osteosynthesis system

FDA 510(k)

FDA Class 2 ·Orthopedic

JULIET PO

FDA 510(k)

FDA Class 2 ·Orthopedic

SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION

FDA 510(k)

FDA Class 2 ·Orthopedic

Juliet® Ti

FDA 510(k)

FDA Class 2 ·Orthopedic

JULIET® LL Lateral Lumbar Cage

FDA 510(k)

FDA Class 2 ·Orthopedic

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R)PROCROSS(TM) OVER THE WIRE BALLON DILATATION CATHETERT WITH RELY TM BALLOON MATERIAL AND HYDRO/PEL