24 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
STAT PROFILE PHOX PLUS L ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040008492·Zirlux 16+ D4 89x17x16
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450267448·
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0120500·Screwdriver, Assembled Screws SNI1
InSePtion MIS Fixation System
FDA UDI
Kalitec Direct LLC·B07314K0120500·Inserter, All-In-One
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033369708·
IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK
FDA 510(k)
FDA Class 2
·Radiology
VECTORSURGE 5, MODEL VS-500
FDA 510(k)
FDA Class 2
·Physical Medicine
CONTOUR®
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 19, 2025
CONTOUR TEST STRIPS
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·May 31, 2012
BREEZE2
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·February 18, 2015
CONTOUR NEXT
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·June 13, 2014
CONTOUR
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 5, 2019
CONTOUR® TS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·August 21, 2025
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 14, 2007
ACCU-CHEK SPIRIT CARTRIDGE
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE AG·Product code LZG·March 20, 2013
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·February 28, 2011
CONTOUR® TS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·August 21, 2025
CONTOUR® TS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 15, 2025
CONTOUR®
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 13, 2025