21 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
STRYKER PLATING SYSTEM BASIC FRAGMENT SET
FDA 510(k)
FDA Class 2
·Orthopedic
ASIA MED
FDA UDI
asia-med GmbH·04251282509378·asia-med Kinesiology Tape - Royal Blue: made o...
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040009130·Zirlux 16+ 0M3 89x17x25
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033369876·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033369869·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033369852·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033369838·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033369845·
IV SET AN122 W/O PUMP T-TYPE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·April 13, 2021
EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
0009613348-2024-012162
FDA Adverse Event
Injury
·INSTITUT STRAUMANN AG·Product code DZE·September 12, 2024
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code LFR·May 16, 2007
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 13, 2013
LANDMARX EVOLUTION PLUS
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION·Product code HAW·February 1, 2011
BD DISCARDIT II 2 ML SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·April 9, 2021
COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·August 29, 2017
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·July 10, 2017
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; 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