POWERTREK INSTRUMENTS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TREACE MAGNUM OTO-TOOL SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

KARTUSH TM PATCHER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Galen ES Cooperative Surgical Assistant Platform, Galen ES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

LAURIMED POLYPVAC MICRODEBRIDER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CERAVITAL CERAMIC EAR CANAL WALL PROSTH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Biodesign Otologic Repair Graft

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EDI-BUR MICRODRILL SYSTEMS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BLACKSTAR(TM) STAR SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

HUMMER IV MICRODEBRIDER SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

KARL STORZ INTRA-HANDPIECES AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat