MODIFICATION TO ACS CORONARY GUIDING

FDA 510(k)

FDA Class 2 ·Immunology

ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM

FDA 510(k)

FDA Class 2 ·Immunology

SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M

FDA 510(k)

FDA Class 2 ·Immunology

SPIFE URINE IFE

FDA 510(k)

FDA Class 2 ·Immunology

BOEHRINGER MANNHEIM IGM ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

K3PRO SURGICAL TRAY

FDA 510(k)

FDA Class 2 ·General Hospital

K3Pro Konus New Abutments and Implants

FDA 510(k)

FDA Class 2 ·Dental

K3PRO Konus Additional Abutments and Implants

FDA 510(k)

FDA Class 2 ·Dental

Altech® Exhalation Valve (Single Limb and Dual Limb)

FDA 510(k)

FDA Class 2 ·Anesthesiology

Ebony PTA 0.035 Peripheral Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ebony HP PTA OTW 0.035 Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Amethyst HP PTA OTW 0.035 Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ebony PTA .014 RX Pheripheral Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Tamarin Blue PTCA RX Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ebony PTA 0.014 RX Peripheral Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System

FDA 510(k)

FDA Class 2 ·Orthopedic

ADVANCE HA COATED SPIKED TIBIAL BASE AND ADVANCE HA COATED MODULAR KEEL

FDA 510(k)

FDA Class 2 ·Orthopedic

PONTO BONE ANCHORED HEARING SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat