17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SONILASE BLUE, SONILASE BLUE-CLEAN, SONILASE BLUE-UV CLEAN PLUS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VITROS CA 19-9
FDA 510(k)
FDA Class 2
·Immunology
HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON
FDA 510(k)
FDA Class 2
·Radiology
SHIDEN HP
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·June 4, 2019
CAPSURE SENSE
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 8, 2013
CONMED GOLDLINE 'A' ROCKER SWITCH PENCIL
FDA Adverse Event
Malfunction
·CONMED ELECTROSURGERY·Product code GEI·June 28, 2011
GE OEC 9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 10, 2008
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
SHIDEN
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·January 6, 2022
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
FDA Enforcement
Class I
·Ongoing·Ventec Life Systems, Inc.·May 13, 2026
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
FDA Enforcement
Class II
·Terminated·Cardiovascular Systems Inc·May 31, 2017
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023