8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RAICHEM AMYLASE REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NA
FDA UDI
Philips Medical Systems Hsg·00884838003361·External Paddles with PCI
XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES
FDA 510(k)
FDA Class 2
·Neurology
CELTRA Press
FDA 510(k)
FDA Class 2
·Dental
ENPULSE DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·June 10, 2014
PDS II (POLYDIOXANONE) SUTURE
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code NEW·October 1, 2010
FLOOR MOUNT FASTENER SNGL PLT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·November 2, 2012
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