Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft

FDA 510(k)

FDA Class 2 ·Orthopedic

ADVIA Centaur Total IgE (tIgE)

FDA 510(k)

FDA Class 2 ·Immunology

NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MID-500

FDA 510(k)

FDA Class 2 ·General Hospital

METOXIT CAM-BLANKS

FDA 510(k)

FDA Class 2 ·Dental

STERILIZATION WRAP-STERISHEET

FDA 510(k)

FDA Class 2 ·General Hospital

Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SMDIE DEVICE INTERFACING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

PAROS CRP

FDA 510(k)

FDA Class 2 ·Immunology

Intrauterine Access Balloon Catheter, Selective Salpingography Catheter

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT)

FDA 510(k)

FDA Class 2 ·Microbiology

Angel Align System

FDA 510(k)

FDA Class 2 ·Dental

MULE

FDA 510(k)

FDA Class 2 ·Physical Medicine

MONICA AN24

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VERIFUSE AMBULATORY PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

BlueStar CGM insulin dose calculator

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CINtec Histology (50 tests), CINtec Histology (250 tests)

FDA 510(k)

FDA Class 2 ·Pathology

CINtec Histology

FDA 510(k)

FDA Class 2 ·Pathology

REP ALP-15, 8, & 4 KITS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry