PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT

FDA 510(k)

FDA Class 2 ·Immunology

mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DIGITAL TEMPERATURE MONITOR; MODEL KY-01

FDA 510(k)

FDA Class 2 ·General Hospital

BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INFUSION SYRINGE SET

FDA 510(k)

FDA Class 2 ·General Hospital

KAPPA & LAMBDA BENCE JONES CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

ANTISERA TO HUMAN FREE LAMBDA LIGHT CH.

FDA 510(k)

FDA Class 2 ·Immunology

Sheath Introducer

FDA 510(k)

FDA Class 2 ·Cardiovascular

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS TX 2000 VP CORONARY DILATATION CATHETER CAHTETERS

EpiFaith Syringe

FDA 510(k)

FDA Class 2 ·General Hospital

BIOTEQ Drainage Catheter Set (One Step Type)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BIOTEQ Drainage Catheter BT-PDS-series

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·DTU-ONE ULTRASOUND SCANNER

RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA

FDA 510(k)

FDA Class 2 ·Hematology

EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)

FDA 510(k)

FDA Class 2 ·General Hospital

GUIDEWIRES

FDA 510(k)

FDA Class 2 ·Cardiovascular