18 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Andersen EOGas 4 SteriTest
FDA 510(k)
FDA Class 2
·General Hospital
BONE SCREW, CORTICAL
FDA UDI
Biomet Orthopedics, LLC·00887868004797·
ProLift Trial
FDA UDI
Life Spine, Inc.·00190837089092·
F-400 SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
K-Y BRAND LONG LASTING VAGINAL MOISTURIZER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
AMIA AUTOMATED PD CYCLER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·December 15, 2020
AMIA AUTOMATED PD CYCLER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·January 12, 2023
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 8, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·June 7, 2013
SCREW
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·June 29, 2011
AMIA AUTOMATED PD CYCLER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·February 15, 2024
HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·August 23, 2019
NI
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·December 20, 2023
NI
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·December 20, 2023
Precise Digital Accelerator Delivery of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 26, 2012
Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 20, 2013
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 12, 2014