ANTISERUM TO HUMAN IGM

FDA 510(k)

FDA Class 2 ·Immunology

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

Ebony PTA 0.035 Peripheral Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

SUNGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

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

M.U. 12 Taurus

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Mesa Ideas SRL·1 device

M.U. 10 Taurus

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Mesa Ideas SRL·5 devices

M.U. 13 Taurus

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Mesa Ideas SRL·1 device

MAU FIA Kit

Basic UDI-DI

EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·1 device

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Implantable Pulse Generators (IPG) Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG; Azu