ALEUTIAN SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CHESAPEAKE (CERVICAL COMPONENTS)

FDA 510(k)

FDA Class 2 ·Orthopedic

EVEREST Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

RANGE/DENALI/MESA Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

CAYMAN BUTTRESS PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Nile Alternative Fixation

FDA 510(k)

FDA Class 2 ·Orthopedic

RANGE SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CAPRI Corpectomy Cage System

FDA 510(k)

FDA Class 2 ·Orthopedic

ALEUTIAN SPACER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Cascadia Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

PYRENEES CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·M-VU ALGORITHM ENGINE

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS HOME UTERINE ACTIVITY MONITORING SYSTEM (HUAM)

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.

DISPOSABLE SURGICAL GOWNS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SLT 220 WASHER FOR MICROITITERPLATES

FDA 510(k)

FDA Class 2 ·Microbiology