INTERBODY INNOVATIONS CEMENT RESTRICTOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GIQuant

FDA 510(k)

FDA Class 2 ·Radiology

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

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

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

Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Surgical Gown

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator

FDA 510(k)

FDA Class 2 ·General Hospital