27 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVIA CENTAUR CKMB AND TROPONIN ULTRA ASSAY
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JHX·July 29, 2010
REF H10
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·August 9, 2016
ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·December 10, 2020
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00530201·
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809845051·FOR MEN 20-30 MM HG KNEE HIGH OPEN TOE SMALL BR...
MicroAire®
FDA UDI
Microaire Surgical Instruments LLC·00847399005120·SST TWIST DRILL, JACOBS, 2mm DIA. X 27mm
Shannon Recta X-Large, quick coupling
FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613293041·
FJ2000 System
FDA UDI
Paragon 28, Inc.·00889795133106·Shannon-style Corta Bone Burr, 3.0 x 20 x 100, ...
CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE
FDA 510(k)
FDA Class 2
·Radiology
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·November 15, 2013
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code KWP·November 15, 2013
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·April 11, 2013
FOUNDATION SHOULDER SYSTEM
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWS·May 27, 2008
FINELINE II
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·April 13, 2011