2,522 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ASPEN ULTRASOUND SYSTEM W/OBSTETRIC CALCULATIONS
FDA Adverse Event
Malfunction
·ACUSON CORP.·Product code IYO·June 27, 1997
PROSOUND F37
FDA Adverse Event
Injury
·HITACHI LTD, HEALTHCARE TOKYO WORKS·Product code IYO·March 31, 2017
NXSTAGE SYSTEM ONE
FDA Adverse Event
Malfunction
·NXSTAGE MEDICAL, INC.·Product code KDI·March 15, 2017
PROSOUND F37
FDA Adverse Event
Malfunction
·HITACHI MEDICAL CORPORATION·Product code IYN·April 9, 2019
NXSTAGE SYSTEM ONE
FDA Adverse Event
Malfunction
·NXSTAGE MEDICAL, INC.·Product code KDI·August 21, 2017
NXSTAGE SYSTEM ONE
FDA Adverse Event
Malfunction
·NXSTAGE MEDICAL, INC.·Product code KDI·April 4, 2018
GUM CRAYLA POWERED TOOTHBRUSH
FDA Adverse Event
Malfunction
·SUNSTAR AMERICAS INC.·Product code JEQ·August 12, 2022
NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED LPS-FLEX ARTICUL
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HSA·August 14, 2008
LOGIQ 5 system models 2331752, 2331753, 2332750, 2353313 and 2355477.
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code IYN·September 2, 2004
LOCIQ Book System models: 2399921, 2399923, 2349933, 2349934 and 2349935
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code IYN·September 2, 2004
VOLUSON E8
FDA Adverse Event
Death
·GE HEALTHCARE·Product code IYO·June 21, 2011
Philips Diagnostic Ultrasound System, Model HD3. Product labeled HD3 Ultrasound System, Distributed by Philips Ultrasound, 22100 Bothell-Everett Highway, Bothell, WA 98021. Pulse Doppler Imaging Systems used for diagnostic ultrasound imaging or fluid analysis of human body.
FDA Recall
Terminated
·Philips Medical Systems·Product code IYN·August 12, 2008
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·November 7, 2023
GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
FDA Enforcement
Class II
·Ongoing·GE Medical Systems China Co., Ltd.·July 2, 2025
Philips Diagnostic Ultrasound System, Model HDI4000. Product labeled HDI4000 Ultrasound System, Distributed by Philips Ultrasound, 22100 Bothell-Everett Highway, Bothell, WA 98021. Product also marketed as Philips 4000 New Standard, Philips 4000 System and Multibeam System. According to the firm, these units have the same user manual as the HDI4000 system. The different names are used internally as a description for the different configurations of model HDI 4000. Over the product lifecycle, the product configuration changed as follows: MULTIBEAM SYSTEM : This was the original HDI 4000 system branded with the former company name 'ATL' and labeled, "Distributed by ATL Ultrasound Bothell, WA. USA 98041"; PHILIPS 4000 SYSTEM :This configuration changed the legacy 'ATL' brand / colors to the 'Philips' brand / colors; PHILIPS 4000 NEW STANDARD: This Philips brand configuration eliminated hardware that supported the 'CV'. The CV option was initially standard, but later became optional depending on customer preference. The product ID label is the same for both PHILIPS 4000 SYSTEM and PHILIPS 4000 NEW STANDARD. Pulse Doppler Imaging Systems used for diagnostic ultrasound imaging or fluid analysis of human body.
FDA Recall
Terminated
·Philips Medical Systems·Product code IYN·August 12, 2008
GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
FDA Recall
Open, Classified
·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code IYN·May 16, 2025
ORBIT BRILLIANT WHITE
FDA Adverse Event
RANIR LLC·Product code EFW·December 19, 2016
COLGATE KIDS DORA THE EXPLORER MANUAL TOOTHBRUSH
FDA Adverse Event
Malfunction
·COLGATE SANXIAO CO., LTD·Product code EFW·November 16, 2016
TOOTHBRUSH, MANUAL
FDA Adverse Event
Malfunction
·RANIR LLC·Product code EFW·October 19, 2016
CHILDRENS SPARKLE TOOTHBRUSH - IMPRINT (144 CT), PS - ALG
FDA Adverse Event
Malfunction
·YOUNG INNOVATIONS LLC DBA PLAK SMACKER·Product code EFW·December 7, 2016