IceCap product line

FDA 510(k)

FDA Class 2 ·Neurology

SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

TRYPTIK2C-plate Anterior Cervical Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

ROMEO 2 PAD POSTERIOR AXIAL DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

JULIET OL

FDA 510(k)

FDA Class 2 ·Orthopedic

JULIET LL

FDA 510(k)

FDA Class 2 ·Orthopedic

Embosphere Microspheres

FDA 510(k)

FDA Class 2 ·Cardiovascular

Perla Posterior Cervico-Thoracic Fixation system

FDA 510(k)

FDA Class 2 ·Orthopedic

Romeo posterior osteosynthesis system

FDA 510(k)

FDA Class 2 ·Orthopedic

JULIET PO

FDA 510(k)

FDA Class 2 ·Orthopedic

SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION

FDA 510(k)

FDA Class 2 ·Orthopedic

Juliet® Ti

FDA 510(k)

FDA Class 2 ·Orthopedic

Ceramic Brackets Orthometric

FDA 510(k)

FDA Class 2 ·Dental

JULIET® LL Lateral Lumbar Cage

FDA 510(k)

FDA Class 2 ·Orthopedic

MONOHAEM (FECAL OCCULT BLOOD TEST)

FDA 510(k)

FDA Class 2 ·Hematology

PHENOBARBITAL FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FILMSAVER, NT VERSION 5.03

FDA 510(k)

FDA Class 2 ·Radiology

CARDIOVASCULAR ARRAY

FDA 510(k)

FDA Class 2 ·Radiology