13 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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