14 results · 19ms · Sources: EU EUDAMED, US FDA

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LIVESURE METHADONE SCREEN TESTS

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

DESIGN OPTICS

FDA UDI
FGX INTERNATIONAL INC.·00193033544747·

AIA-PACK BRCA, ST AIA PACK BRCA

FDA 510(k)
FDA Class 2 ·Immunology

ADVIA 120 HEMATOLOGY

FDA 510(k)
FDA Class 2 ·Hematology

MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

FDA Adverse Event
Malfunction ·C.T.M. SHANGHAI·Product code INI·March 20, 2013

NA

FDA Adverse Event
Malfunction ·ARROW INTL., INC.·Product code FOZ·February 4, 2011

EASY LOAD INSERTER

FDA Adverse Event
Injury ·BAUSCH & LOMB·Product code MSS·March 14, 2008

BD SYRINGE 3ML LL TIP BULK CONVENIENCE PAK

FDA Adverse Event
Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·September 9, 2025

BD SYRINGE 3ML LL TIP BULK CONVENIENCE PAK

FDA Adverse Event
Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·September 9, 2025

BD SYRINGE 3ML LL TIP BULK CONVENIENCE PAK

FDA Adverse Event
Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·September 9, 2025

UNKNOWN

FDA Adverse Event
Malfunction ·COOK INC·Product code BWC·September 4, 2019

bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

FDA Enforcement
Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022