15 results
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26ms
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Sources: EU EUDAMED, US FDA
QWIK-CALL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Kinetic Dynamic Anterior Cervical Plate System
FDA UDI
Life Spine, Inc.·00190837004927·
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981127008·Angled Springloaded Awl, 10mm
Persona®
FDA UDI
Zimmer, Inc.·00889024552456·
Persona®
FDA UDI
Zimmer, Inc.·00889024552555·
Persona®
FDA UDI
Zimmer, Inc.·00889024552500·
GE LIGHTSPEED XTRA CT SCANNER SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CUR Model 1
FDA 510(k)
FDA Class 2
·Neurology
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 10, 2014
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS·Product code MKJ·October 31, 2012
8800
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·September 17, 2010
LAERDAL Silicone Resuscitator (LSR), Pediatric Size, containing an Intake/Reservoir Valve. Sold as Part Nos: 860050-Pediatric Basic w/o Mask in Carton; 860051-Pediatric Complete in Carton; 860052-Standard Child w/Child Mask 3-4 in Carton; 860053-Pediatric Complete in Compact Case; 860055-Pediatric Complete in Display Case; 860056-Standard Term-Baby w/Infant Mask 0-1 in Carton; 865500-Pediatric Upgrade Kit . Responsible firm on the label: Distributed in the U.S. by Laerdal Medical Corporation, Wappingers Falls, NY, Made in Norway.
FDA Recall
Terminated
·Laerdal Medical Corporation·Product code BTM·December 23, 2003
IQon Spectral CT - Model no. 728332, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018
IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 14, 2018
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012