10 results
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20ms
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Sources: EU EUDAMED, US FDA
KING DIAGNOSTICS URIC ACID TEST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
K2-HF SHOULDER, SH-8 OP powder, 20g.
FDA UDI
Yeti Dentalprodukte GmbH·EYET38622080·
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981144517·Modular Trial 16x14x8mm, 10 Deg Lordosis, w/ De...
DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent
FDA 510(k)
FDA Class 2
·Immunology
LEUKOCYTE VOL. ANALYSIS APPARATUS
FDA 510(k)
FDA Class 2
·Hematology
EVERA S DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 10, 2014
ARCHITECT IVANCOMYCIN
FDA Adverse Event
Malfunction
·ABBOTT GERMANY·Product code LEH·October 8, 2010
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·December 7, 2012
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020
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