44 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QUANTRA
FDA 510(k)
FDA Class 2
·Radiology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694043830·2.0mm 7 Hole Curved Locking Plate, 2.0mm thick
AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
M2A MAGNUM SYSTEM
FDA 510(k)
FDA Class 3
·Orthopedic
36MM COCR BIOMET FEM HD STD NK
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·June 13, 2016
UNKNOWN EXCEED HIP
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·August 5, 2016
UNKNOWN RECAP 48MM HEAD
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·September 16, 2016
36MM 12/14 TPR FEM HEAD -4 NK
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·June 28, 2016
EXCEED ABT M2A-36 MOD HEAD
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·June 28, 2016
EXCEED ABT RINGLOC-X SHELL
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·July 20, 2017
M2A MOD HD COCR DIA28/+3MM T1
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·December 23, 2015
32MM COCR BIOMET FEM HD STD NK
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·February 16, 2016
RECAP/MAGNUM ACETABULAR SHELL
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·February 15, 2017
EXCEED ABT M2A-36 MOD HEAD -3MM T1
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·June 1, 2016
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
AU2700 CLINICAL CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER MISHIMAK.K.·Product code JJE·June 28, 2011
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 4, 2014
RECAP SHELL COCR PC DIA56/50MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·September 1, 2016
36MM COCR BIOMET FEM HD +6 NK
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·September 7, 2018
EXCEED ABT STD SHELL PC DIA50M M
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·July 16, 2016