619 results · 23ms · Sources: EU EUDAMED, 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