Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC CAPSURE SP NOVUS MODELS 4092 AND 4592 AND VITATRON EXCELLENCE PS & MODELS IMK49B AND IMK 49JB

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Paradigm Real-Time Revel System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM; DEXCON G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME INSULIN PUMP

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G system, MiniMed 770G system and MiniMed 780G system

FDA Pre-Market Approval

BRACAnalysis CDx

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

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...

DRIVEMEDICAL

FDA UDI

Drive Devilbiss Healthcare·00822383126401·Patient RoomMayo stands Product Description: In...

SubQ It!

FDA UDI

OPUS KSD, INC.·00867469000213·SubQ It! Bioabsorbable Skin Closure SF10 is a s...