SELISA ANTI-N DNA ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5)

FDA 510(k)

FDA Class 2 ·Radiology

AUTOZYME SCREEN

FDA 510(k)

FDA Class 2 ·Immunology

CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES

FDA 510(k)

FDA Class 2 ·Cardiovascular

HammerTechTM Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo® Transforaminal Lumbar Interbody Fusion device (TLIF); aprevo® Anterior Lumbar Interbody Fusion device with Interfixation (ALIF-X)

FDA 510(k)

FDA Class 2 ·Orthopedic

LAKE WOUND CARE/TREATMENT KIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SeaSpine Reef TH System

FDA 510(k)

FDA Class 2 ·Orthopedic

LAKE MALE EXTERNAL CATHETERIZATION KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OPERAID SURGICAL DRAIN

FDA 510(k)

FDA Class 2 ·Ophthalmic

RAPIDTEG TEG-ACT TEST

FDA 510(k)

FDA Class 2 ·Hematology

Imperative Care Radial 088 Access System

FDA 510(k)

FDA Class 2 ·Cardiovascular

MIKRO-CATH, MODEL 825-0101

FDA 510(k)

FDA Class 2 ·Cardiovascular

TAMA BEMS device

FDA 510(k)

FDA Class 2 ·Neurology

AZURE ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

PolyLock Small Bone Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

STAGE ZERO AIR FLOTATION BED

FDA 510(k)

FDA Class 2 ·Physical Medicine

LAKE DISPOSABLE PROBE COVER

FDA 510(k)

FDA Class 2 ·General Hospital

OPTIMA NM/CT 640

FDA 510(k)

FDA Class 2 ·Radiology