18 results · 21ms · Sources: EU EUDAMED, US FDA

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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