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MODIFICATION TO AURORA MRI SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

AURORA MR-GUIDED INTERVENTIONAL SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

V.A.D. ACCESS KIT

FDA 510(k)
FDA Class 2 ·General Hospital

SENSITESTER

FDA 510(k)
FDA Class 1 ·Neurology

HAYFEVER HELMET

FDA 510(k)
FDA Class 2 ·General Hospital

MR INSPIRE WITH EXTENDED KIT

FDA 510(k)
FDA Class 2 ·Radiology

HEMAPROMPT

FDA 510(k)
FDA Class 2 ·Hematology

LUBREASE FEMALE LUBRICANT

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Hepatocyte Specific Antigen (HSA)

FDA UDI
BIOCARE MEDICAL LLC·00847627011268·

hCG (Beta)

FDA UDI
BIOCARE MEDICAL LLC·00847627012135·

ANTI-BETA-HCG

FDA UDI
BIOGENEX LABORATORIES·00810119678737·

MedTest DX HCG Control Set Level B

FDA UDI
Medtest Dx, Inc.·00817439020857·HCG Control Set Level B, for In Vitro Diagnosti...

HCG SERUM CONTROL KIT

FDA UDI
SEKISUI DIAGNOSTICS, LLC·00742860100093·

Lumipulse G BHCG Calibrators

FDA UDI
FUJIREBIO INC.·04987270231111·

Dimension Vista® BHCG CAL

FDA UDI
Siemens Healthcare Diagnostics Inc.·00842768016516·Beta Human Chorionic Gonadotropin Calibrator, 2...

HEMOSURE®

FDA UDI
HEMOSURE INC.·00857338006347·Hemosure hCG Controls Set 2ml.

Elecsys HCG CalSet

FDA UDI
Roche Diagnostics GmbH·04015630919406·

MedTest DX HCG Control Set Level A

FDA UDI
Medtest Dx, Inc.·00817439020833·HCG Control Set Level A, for In Vitro Diagnosti...

MedTest DX Elevated HCG Control Vial Label - A

FDA UDI
Medtest Dx, Inc.·00817439020826·Elevated HCG Control Vial Label - A, for In Vit...