17 results · 37ms · Sources: EU EUDAMED, US FDA

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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