VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH

FDA 510(k)

FDA Class 2 ·Hematology

NBS CONNECTING TUBE SET

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SENTRY II NONINDWELLING BLOOD PRESSURE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)

FDA 510(k)

FDA Class 2 ·Neurology

BIO-RAD VARIANT NBS SICKLE CELL PROGRAM

FDA 510(k)

FDA Class 2 ·Hematology

QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN ANTI-LKM-1 ELISA(LGG)

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE LKM-1 ELISA

FDA 510(k)

FDA Class 2 ·Immunology

Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)

FDA classification

FDA Class 2 ·Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)

BBS REVOLUTION

FDA 510(k)

FDA Class 2 ·Radiology

PERMATHANE 865 & 867 UNIPOLAR POLYURETH

FDA 510(k)

FDA Class 2 ·Cardiovascular

DentCare Aligners

FDA 510(k)

FDA Class 2 ·Dental

INTRAUTERINE CATHETER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

STOPCOCK

FDA 510(k)

FDA Class 2 ·General Hospital

Peridot Intervertebral body fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

Peridot Spinal Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

The JASPER Spinal Fixation System II

FDA 510(k)

FDA Class 2 ·Orthopedic

Prase PEEK Anterior Cervical Interbody Spacer

FDA 510(k)

FDA Class 2 ·Orthopedic

Peridot-EX Expandable Intervertebral Body Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system

FDA 510(k)

FDA Class 2 ·Orthopedic