12 results
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20ms
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Sources: EU EUDAMED, US FDA
SHILEY DISP. CANNULA CUFFLESS TRACEOSTOMY TUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
Archon
FDA UDI
Nuvasive, Inc.·00887517304940·Archon Screw, 4.5x14mm S.T. Var Recon
PICO Single Use Negative Pressure Wound Therapy System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DR VISION NEO, DR VISION DOU
FDA 510(k)
FDA Class 2
·Radiology
CELL-DYN 3700 SL ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·February 22, 2019
MINI-CAP, DISCONNECT W/PVP-1SOLUTION
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·October 22, 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
EQ REV LOCKING SCREW
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code MEH·January 13, 2026
EQUINOXE REVERSE SHOULDER COMPONENT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code PHX·January 13, 2026
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
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