12 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ADVIA Centaur® Cleaning Solution Concentrate
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414182230·Cleaning solution - CENTAUR - CAL - 12 Bottles
31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T
FDA 510(k)
FDA Class 2
·Radiology
OLYMPUS INSTRUMENT TRAY
FDA 510(k)
FDA Class 2
·General Hospital
AFX
FDA Adverse Event
Injury
·ENDOLOGIX·Product code MIH·December 29, 2015
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
PINGHU WEIFENG MATERIAL TECHNOLOGY·Product code IKX·May 14, 2013
ASR ACETABULAR IMPLANT 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·May 19, 2011
ENDO STITCH 10MM SUTURING DEVICE
FDA Adverse Event
Malfunction
·NORTH HAVEN - USS·Product code MFJ·August 11, 2008
ZIMMER AIR DERMATOME
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code GFD·November 7, 2017
ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (For in vitro diagnostic use with the ADVIA¿ Centaur systems) Catalog Number: 112748 (Siemens Material Number (SMN): 10310041 The Cleaning Solution is a component of the ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP instruments, and therefore does not have independent Instructions for Use (IFU). Information regarding use of the Cleaning Solution is contained in the owner's manual for the instruments.
FDA Enforcement
Class III
·Terminated·Siemens Healthcare Diagnostics, Inc·November 26, 2014
ADVIA Centaur and ADVIA Centaur XP and ADVIA Centaur CP Cleaning Solution (For in vitro diagnostic use with the ADVIA Centaur systems) Catalog Number: 112748 (Siemens Material Number (SMN): 10310041 The Cleaning Solution is a component of the ADVIA Centaur and ADVIA Centaur XP and ADVIA Centaur CP instruments, and therefore does not have independent Instructions for Use (IFU). Information regarding use of the Cleaning Solution is contained in the owner's manual for the instruments.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JJE·September 12, 2014
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021