13 results
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26ms
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Sources: EU EUDAMED, US FDA
GER 540, GER 541 MANUAL BED
FDA 510(k)
FDA Class 1
·General Hospital
Cortera
FDA UDI
Xtant Medical Holdings, Inc.·00840311233960·Tap, NAV, Open Cann, 6.0
NA
FDA UDI
aap Implantate AG·04042409452406·Double Drill Guide Ø1.0/Ø2.0
UniTip Catheter
FDA UDI
Unisensor AG·07640172972397·
UniTip Catheter
FDA UDI
Unisensor AG·07640172972403·
UniTip Catheter
FDA UDI
Unisensor AG·07640172971383·
ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L
FDA 510(k)
FDA Class 2
·Cardiovascular
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·May 7, 2014
CAPSURE SP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
ALARIS SE PUMP ADMINISTRATION SET
FDA Adverse Event
Death
·CAREFUSION CORPORATION·Product code FPA·August 18, 2010
MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code HWC·May 27, 2016
Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules intended for use in todays growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 14, 2013