8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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METHODS FOR THE DIMENSION CLINICAL CHEM. SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
EasyTouch
FDA UDI
MHC MEDICAL PRODUCTS, LLC·MHC18629551·
Multi-Modality Tumor Tracking (MMTT) application
FDA 510(k)
FDA Class 2
·Radiology
POWDER FREE LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
FDA 510(k)
FDA Class 1
·General Hospital
ENRHYTHM DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code DXY·October 9, 2010
GEMSTAR PAIN MGE SNG
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 20, 2014
WHEELCHAIR ACCESSORY
FDA Adverse Event
NEW PROKIN·Product code INE·December 10, 2012
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
FDA Enforcement
Class II
·Terminated·Isopure Corp·September 21, 2022