10 results
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19ms
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Sources: EU EUDAMED, US FDA
BIOTIS BISMUTH SULFITE AGAR
FDA 510(k)
FDA Class 1
·Microbiology
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490482479·INSTRUMENT 6860402 PLATE BENDER
Stainless Steel Wire
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746049675·WIRE SS POSTED 018 26MM FORM I 10/PK
UniTip Catheter
FDA UDI
Unisensor AG·07640172971833·
GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR)
FDA 510(k)
FDA Class 1
·General Hospital
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·November 5, 2012
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·June 10, 2014
INFANT NASAL CPAP CANNULA, SIZE 3
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BZD·September 27, 2010
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