20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SILICONE TRACHEAL T-TUBES
FDA 510(k)
FDA Class 2
·Anesthesiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04047872673136·LEVAMED STABILI-TRI ANK SUP BLU L I
OneLIF™
FDA UDI
Novapproach Spine LLC·G07001332110000·Retention Plate, Oblique-Only, Large, 10 mm
OneLIF™
FDA UDI
Novapproach Spine LLC·G07001332111220·Retention Plate, Oblique-Only, Large, 11 mm - 2...
OneLIF™
FDA UDI
Novapproach Spine LLC·G07001332112220·Retention Plate, Oblique-Only, Large, 12 mm - 2...
MODULAR FOOT SYSTEM - 2.7 MM MODULE
FDA 510(k)
FDA Class 2
·Orthopedic
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR
FDA 510(k)
FDA Class 1
·General Hospital
XPS® BUR GUARD - VISAO®
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code ERL·April 22, 2016
PENUMBRA SMART COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·August 7, 2017
EXPRESS® LD ILIAC / BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIO·March 20, 2013
RENEGADE HI-FLO MICROCATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KRA·March 10, 2011
ONYX, AVM
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code MFE·March 12, 2008
XPS® BUR
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code EQJ·March 13, 2017
BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·July 31, 2019
Q-SYTE CLOSED LUER ACCESS DEVICE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·November 13, 2020
BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·July 8, 2022
BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·March 7, 2018
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
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
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018