17 results
·
37ms
·
Sources: EU EUDAMED, US FDA
Fluent Inflation Device
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Orthopedic
ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX
FDA 510(k)
FDA Class 1
·General Hospital
SHIDEN HP
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·June 4, 2019
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 7, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 28, 2011
GE OEC 7700
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
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·January 28, 2026
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
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024