16 results
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23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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F3
FDA 510(k)
FDA Class 2
·Physical Medicine
MAXIM® VI KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00887868225949·
MAXIM VI KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304205871·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197045841·Bonney Tissue Forceps
1x2 te...
PANEL PHOENIX NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·December 5, 2023
FALCON SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
STRYKER SPINE TRIO PS
FDA 510(k)
FDA Class 2
·Orthopedic
ABBOTT "LIFESHIELD"
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code FPA·October 6, 2003
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 8, 2023
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·November 10, 2020
OT ULTRA2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE GMBH·Product code NBW·April 18, 2019
VICTORY XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CRMD·Product code DXY·January 13, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 3, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 28, 2011
SOLARICE RX
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO·Product code LOX·August 26, 2019
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020