11 results
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20ms
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Sources: EU EUDAMED, US FDA
SUNBEAM ULTRASONIC DENTURE CLEANER MODEL 4220
FDA 510(k)
FDA Class 1
·Dental
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860118220·Standard Band, Tooth 15-14/24-25, Size 18/Roth 22
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860118000·Standard Band, Tooth 15-14/24-25, Size 18
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860118180·Standard Band, Tooth 15-14/24-25, Size 18/Roth 18
SSP PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
STROPP (Single Tunnel Repair of Plantar Plate)
FDA 510(k)
FDA Class 2
·Orthopedic
SECURA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 10, 2014
CATALYS PRECISION LASER SYSTEM
FDA Adverse Event
Injury
·OPTIMEDICA CORPORATION·Product code OOE·December 1, 2012
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 21, 2010
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
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