KARL STORZ INTRA-HANDPIECES AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SHEA FOOTPLATE MICRODRILL

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

UNIDRIVE II PLUS DISPOSABLE TUBING SET

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

XPS 3000 SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

FISCH DRILL SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

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

Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)

FDA 510(k)

FDA Class 2 ·Neurology

Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090)

FDA 510(k)

FDA Class 2 ·Cardiovascular

DYMAXEON SPINE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Mesh, Surgical, Polymeric

FDA Pre-Market Approval

FDA Class 2 ·FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT

Mesh, Surgical, Polymeric

FDA Pre-Market Approval

FDA Class 2 ·FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT

Mesh, Surgical, Polymeric

FDA Pre-Market Approval

FDA Class 2 ·FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT

Mesh, Surgical, Polymeric

FDA Pre-Market Approval

FDA Class 2 ·FOCALSEAL-L SYNTHETIC ABLSORBABLE SEALANT

Mesh, Surgical, Polymeric

FDA Pre-Market Approval

FDA Class 2 ·FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT

Monobond Etch & Prime

FDA 510(k)

FDA Class 2 ·Dental