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