System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·HER2 FISH PHARMDX KIT

Sage AirTAP LC

FDA UDI

SAGE PRODUCTS, LLC·00618029720856·Sage AirTAP LC 10 Pack Configuration

Medfusion

FDA UDI

SMITHS MEDICAL MD, INC.·10610586041259·

Purple NeoFeed Pump

FDA UDI

CME AMERICA LLC·B101100110PSLA0·Pump, Wall Charger, Operator's Manual

Alaris

FDA UDI

CAREFUSION 303, INC.·10885403811012·Alaris Syringe Module

Alaris

FDA UDI

CAREFUSION 303, INC.·10885403517945·Alaris PCA Module (REM V12.3+)

NA

FDA UDI

B. BRAUN MEDICAL INC.·04046964958212·EXTERNAL BOLUS BUTTON ASSET

Perfusor®

FDA UDI

B. BRAUN MEDICAL INC.·04046963915308·Perfusor® PCA Syringe Pump

Medfusion

FDA UDI

Smiths Medical ASD, Inc.·10610586043307·

Alaris

FDA UDI

CAREFUSION 303, INC.·10885403516030·Alaris PCA Module (R V12.3+)

T34L Syringe Pump System

FDA UDI

CME AMERICA LLC·B101100100PSLA0·Pump, wall charger, operations manual

Medfusion

FDA UDI

SMITHS MEDICAL MD, INC.·10610586032318·

Novum IQ

FDA UDI

BAXTER HEALTHCARE CORPORATION·05413765852428·The Novum IQ Syringe Pump is software controll...

Medfusion

FDA UDI

SMITHS MEDICAL MD, INC.·10610586041242·

T34 Syringe Pump

FDA UDI

CME AMERICA LLC·B101100100SA0·

MEDFUSION

FDA UDI

Smiths Medical ASD, Inc.·15019517154313·

Perfusor®

FDA UDI

B. BRAUN MEDICAL INC.·04046963716745·Perfusor® Space® Infusion Pump System

T-34L Purple NeoFeed Enteral Pump

FDA UDI

CME AMERICA LLC·B101100110SLA0·

Alaris

FDA UDI

CAREFUSION 303, INC.·10885403515316·Alaris PCA Module R

Alaris

FDA UDI

CAREFUSION 303, INC.·10885403515323·Alaris Syringe Module R