EBI ESL PEEK-OPTIMA SPINE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO EBI XFIX DFS SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

EBI OSTEOSTIM GRANULES-RESORBABLE BONE GRAFT SUBSTITUTE

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO EBI OMEGA 21 SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

EBI XFIX DFS OPTIROM ELBOW FIXATOR

FDA 510(k)

FDA Class 2 ·Orthopedic

ACUMEN IMAGE GUIDED SURGICAL SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

EBI X FIX DYNAFIX SYSTEM (DFS)

FDA 510(k)

FDA Class 2 ·Orthopedic

EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

EBI DFS JOINT FIXATOR, MODEL 02800

FDA 510(k)

FDA Class 2 ·Orthopedic

Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ORTHOMET LHMC FEMORAL STEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS ANTI-HCV

EBI SMALL EXTERNAL FIXATOR (S/E/F/)

FDA 510(k)

FDA Class 2 ·Orthopedic

EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

Electric Breast Pump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Proture Double Electric Breast Pump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OMEGA 21 SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I.

FDA 510(k)

FDA Class 2 ·Cardiovascular