9 results
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17ms
·
Sources: EU EUDAMED, US FDA
AUTOEXPANDABLE SPECULUM MODEL LEIBOVIC LARGE #4
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FAST1 Intraosseous Infusion System; FASTResponder Sternal Intraosseous Device
FDA 510(k)
FDA Class 2
·General Hospital
SCIENT'X TRIBECA VBR
FDA 510(k)
FDA Class 2
·Orthopedic
DIRECT DRIVE
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES CORP.·Product code FZP·October 5, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 30, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·December 19, 2012
Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. Component of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025
Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017