9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
VISITEC IRRIGATION CONTROL SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
FDA 510(k)
FDA Class 2
·Microbiology
Fehling-Punches
FDA 510(k)
FDA Class 2
·Neurology
HEARTSTART MRX-EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·March 18, 2009
DISPOSABLE ENDOSCOPIC CLEANING BRUSH
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code MNL·April 4, 2014
SYNVISC (HYLAN G-F 20) INJECTION
FDA Adverse Event
Other
·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·September 30, 2010
Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866
FDA Enforcement
Class II
·Terminated·Cook Inc.·February 12, 2020
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015