eUnity

FDA 510(k)

FDA Class 2 ·Radiology

Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS

FDA 510(k)

FDA Class 2 ·Radiology

SYNTRON QUIKSTRIP/E.Z. STRIP PREGNANCY HOME TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX

FDA 510(k)

FDA Class 2 ·Cardiovascular

RIGHT ATRIAL CATHETER CATALOG NO. RAC - XXX SERIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOTOMY RESERVOIR BRS-XXX & HOLDER BRS-HXX

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOTOMY RESERVOIR BRS-XXX SERIES &

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEMOLASER HEMOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VENOUS RESERVOIR VRS-XXX SERIES; HOLDER VRS-HXX

FDA 510(k)

FDA Class 2 ·Cardiovascular

Exam Vue DR

FDA 510(k)

FDA Class 2 ·Radiology

Catheter, Angioplasty, Peripheral, Transluminal

FDA Pre-Market Approval

FDA Class 2 ·ULTRA2 CUTTING BALLOON MONORAIL(MR)

EBI OMEGA21 SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SOLITAIRE-C CERVICAL SPACER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

EBI ESL SPINE SPACER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

EBI ACUMEN SURGICAL NAVIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

MODIFICATION TO EBI SPINELINK SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic