CEDIA DAU LSD ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AmCAD-UV

FDA 510(k)

FDA Class 2 ·Radiology

AmCAD-US

FDA 510(k)

FDA Class 2 ·Radiology

EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EQUATE(TM) AQR APO AL/B DUO CONTROL

FDA 510(k)

FDA Class 2 ·Immunology

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·TANDEM(R) E CEA IMMUNORADIOMETRIC ASSAY

GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle

FDA 510(k)

FDA Class 2 ·Orthopedic

PEEP VALVE

FDA 510(k)

FDA Class 2 ·Anesthesiology

MAXVIEW DIAGNOSTIC WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)

FDA 510(k)

FDA Class 2 ·Physical Medicine

SURGICAL FACE MASK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MILLS COLUMELLA PROSTHESIS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ENDOLYMPHATIC SAC TO MASTOID T-SHUNT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DILKES LASER/SUCTION CANNULAE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SINGH SPEECH SYSTEM (SERIES 'SSS')

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat