9 results · 18ms · Sources: EU EUDAMED, US FDA

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TICARCILLIN 75MCG. SENSI-DISC

FDA 510(k)
FDA Class 2 ·Microbiology

MOBICATH TRANSSEPTAL NEEDLE

FDA 510(k)
FDA Class 2 ·Cardiovascular

Sentimag System

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

PLUM A+ DRIVER NEW

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·February 7, 2014

LOCKING SCREW

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·November 7, 2012

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2015

MEDTRONIC TRANSCATHETER VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·January 5, 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

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