29 results
·
25ms
·
Sources: EU EUDAMED, US FDA
ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814589·GENUMEDI SAND SIZE VII
VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY
FDA 510(k)
FDA Class 2
·General Hospital
SA6000II DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 30, 2022
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NKB·May 1, 2014
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 2, 2012
SHIDEN HP
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·June 4, 2019
HARMONIC SYNERGY* CURVED BLADE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 9, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 19, 2014
OSVII CATH.5CM, AVEC ANT
FDA Adverse Event
Malfunction
·INTEGRA, BIOT·Product code JXG·May 4, 2011
SHIDEN HP
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·March 1, 2024
SHIDEN
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·July 10, 2020
DIVA
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·July 7, 2020
DIVA
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·July 7, 2020
SHIDEN HP
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·April 18, 2022
SHIDEN
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·September 2, 2021
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·May 25, 2016
SHIDEN
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·January 6, 2022
The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·March 10, 2021