Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENSRINS(R) STERILE PRESERVED SALINE SOLN

OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DIEGO ELITE DRILL

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

XPS 3000 SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Celeris, Disposable Sinus Debrider

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SODEM HIGH SPEED SYSTEM (PNEUMATIC)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

APEX UNIVERSAL DRIVE SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

INTRAARC DRIVE SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SEPRAGEL ENT BIORESORBABLE PACKING/STENT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TISSUE INTEGRATED PROSTHESIS DRILL

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

OCM-G1 Attachment

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

GELITA-SPON ABSORBABLE GELATIN SPONGE, USP

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PNEUMATIC CUTTER SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

XPS STRAIGHTSHOT MICRORESECTOR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

hekaDrill

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat