619 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MammaPrint
FDA 510(k)
FDA Class 2
·Immunology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772344093·PROTECT.PRO ACTION BACK SUPPORT BLACK S
Tasso+ Convenience Kit
FDA UDI
Tasso Inc.·00850038691028·
LEONE SPA
FDA UDI
LEONE SPA·08033707036616·DB BRACKETS 22 BH 2nd BIC U/R L/L
Lockheed - 18 Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588015026·Lockheed - 18 Metal
Blade Handle
FDA UDI
KATENA PRODUCTS, INC.·00841668112373·CHUCK HANDLE #3KA 7.5CM LONG
BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated
FDA Enforcement
Class II
·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·August 14, 2013
OXO
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC (LITTLETON)·Product code OWB·February 11, 2019
SURECAN SAFETY II
FDA Adverse Event
Malfunction
·B.BRAUN MEDICAL SAS·Product code PTI·February 27, 2020
HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
FDA Adverse Event
Malfunction
·HEARTWARE, INC.·Product code DSQ·June 19, 2018
HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
FDA Adverse Event
Malfunction
·HEARTWARE, INC.·Product code DSQ·June 19, 2018
HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
FDA Adverse Event
Malfunction
·HEARTWARE, INC.·Product code DSQ·December 13, 2018
OXYGENATOR WITH INTEGRATED HEAT EXCHANGER
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·February 18, 2019
HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY
FDA Adverse Event
Malfunction
·HEARTWARE, INC.·Product code DSQ·January 31, 2019
HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
FDA Adverse Event
Malfunction
·HEARTWARE, INC.·Product code DSQ·February 25, 2019
BD VACUTAINER® PST¿ GEL LITHIUM HEPARINN BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·June 21, 2018
HEARTWARE VENTRICULAR ASSIST SYSTEM- CONTROLLER 2.0
FDA Adverse Event
Malfunction
·HEARTWARE, INC.·Product code DSQ·May 31, 2018
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011