13 results · 27ms · Sources: EU EUDAMED, US FDA

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Powder Free Nitrile (Black) Examination Gloves

FDA 510(k)
FDA Class 1 ·General Hospital

ProLift Trial

FDA UDI
Life Spine, Inc.·00190837088583·

3M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAM

FDA 510(k)
FDA Class 2 ·General Hospital

MEVIS LIVERANALYSER/LIVERVIEWER SOFTWARE

FDA 510(k)
FDA Class 2 ·Radiology

BIT, DRILL

FDA Adverse Event
Malfunction ·SYNTHES, USA·Product code HTW·October 14, 2016

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

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code OTN·June 7, 2013

OVATIO

FDA Adverse Event
Malfunction ·SORIN CRM·Product code MRM·June 24, 2011

CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

FDA Adverse Event
Other ·EDWARDS LIFESCIENCES·Product code LWR·September 5, 2008

AMIA AUTOMATED PD CYCLER SET

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·February 15, 2024

SHAFT FOR 90° SCREWDRIVER

FDA Adverse Event
Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code DZI·November 27, 2018

Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·April 9, 2014