D100 COMPUTER CARDIAC ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

THE FINGER GUARD

FDA 510(k)

FDA Class 2 ·Cardiovascular

PLURIMUS CARDIAC EVALUATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

D200 ADVANCED COMPUTER CARDIAC ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

GLOBAL PHARMA CM S.A

Manufacturer

🇵🇱 Poland·52 Basic UDI-DIs·52 Devices·TUV NORD Polska Sp. z o.o, TUV NORD Polska Sp. z o.o, TUV NORD Polska Sp. z o.o, and TUV NORD Polska Sp. z o.o

Colgate-Palmolive Industrial Ltda

Manufacturer

🇧🇷 Brazil

Catheter, Angioplasty, Peripheral, Transluminal

FDA Pre-Market Approval

FDA Class 2 ·ULTRA2 CUTTING BALLOON MONORAIL(MR)

EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001

FDA 510(k)

FDA Class 2 ·Microbiology

X-RAY GENERATOR MODEL KXO-15

FDA 510(k)

FDA Class 1 ·Radiology

AFFIRMAGEN

FDA UDI

ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750003914·0.8% Affirmagen® 3 (Pooled Cells)

Biotestcell® A1 & B

FDA UDI

Bio-Rad Medical Diagnostics GmbH·07611969952663·Reagent Red Blood Cells; Biotestcell® A1 & B; 3...

IH-Cell A1 & B

FDA UDI

Bio-Rad Medical Diagnostics GmbH·07611969952243·Reagent Red Blood Cells; 0.6 ± 0.1 %; Pooled ce...

Erytypecell® A1 & B

FDA UDI

Bio-Rad Medical Diagnostics GmbH·07611969952656·Reagent Red Blood Cells; 1.0 - 1.3%;pooled cell...

Reverse-Cyte 0.8% (A1, A2, B)

FDA UDI

Medion Grifols Diagnostics AG·07640137340322·Reagent Red Blood Cells for confirmation of ABO...

AFFIRMAGEN

FDA UDI

ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750003907·Affirmagen® (Pooled Cells)

Referencells A1 and B

FDA UDI

IMMUCOR, INC.·10888234000273·This configuration of the product contains two ...

AFFIRMAGEN

FDA UDI

ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750003877·0.8% Affirmagen® (Pooled Cells)

Reverse-Cyte 3% (A1, B)

FDA UDI

Medion Grifols Diagnostics AG·07640137340292·Reagent Red Blood Cells for confirmation of ABO...

Beckman Coulter® PK® Systems Reagent Red Blood Cells (A1 & B)

FDA UDI

DIAGAST·33661562173182·Reagent Red Blood Cells A1 and B cells formulat...

Referencells A1, A2, B and O

FDA UDI

IMMUCOR, INC.·10888234000259·This configuration of the product contains four...