55 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AIRGUARD VALVED INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
SlimLine®
FDA UDI
ZIMMER SPINE, INC.·00889024404151·
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710420420360·Anterio Lateral Closing Wedge Osteotomy Guide, ...
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710410420360·Anterior Closing Wedge Osteotomy Guide, 42mm x ...
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710400420360·Anterior Dome Osteotomy Guide, 42mm x 36mm
OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD
FDA 510(k)
FDA Class 2
·Cardiovascular
SIEMENS VIRTUAL SIMULATION (VSIM)
FDA 510(k)
FDA Class 2
·Radiology
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
RED DCI-DC3 SENSOR
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·September 15, 2015
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
RD SET GE - 12
FDA Adverse Event
Malfunction
·Product code DQA·August 13, 2021
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
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
FDA Adverse Event
Death
·THORATEC CORP.·Product code DSQ·April 4, 2013