10 results
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26ms
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Sources: EU EUDAMED, US FDA
ELECTROPHORESIS WORK CENTER (EWC)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Bard® Foley Tray with Hydrophilic-Coated Foley Catheter
FDA UDI
C. R. Bard, Inc.·00801741024757·Bard® Foley Tray with Hydrophilic-Coated Foley ...
EXPEDITIONARY DELPLOYABLE OXYGEN CONCENTRATION SYSTEM (EDOCS), MODELS 120B AND 30;MOBILE OXYGEN STORAGE TANK (MOST), MOD
FDA 510(k)
FDA Class 2
·Anesthesiology
Anatomic Total Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
MALLORY/HEAD - PF ACETABULAR COMPONENT
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·March 8, 2017
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 13, 2014
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)·Product code DQK·December 7, 2012
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 22, 2015
ANATOMIC
FDA Adverse Event
Malfunction
·AMPLITUDE·Product code JWH·December 11, 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