10 results
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20ms
·
Sources: EU EUDAMED, US FDA
EIKEN KIZAI ARTIFICIAL KIDNEY BLOOD CIR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNKNOWN DEPUY POLY LINER
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code JDI·November 8, 2012
POSEY BED
FDA Adverse Event
Malfunction
·J. T. POSEY CO.·Product code OYS·February 20, 2014
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SPINE LLC.·Product code NDN·August 26, 2010
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012