51 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Aveta Waste Bag with Tissue Catch
FDA UDI
MEDITRINA, INC.·00850006759736·Aveta Waste Bag with Tissue Catch for use with ...
LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS
FDA 510(k)
FDA Class 2
·Dental
HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009
FDA 510(k)
FDA Class 2
·Anesthesiology
GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·July 30, 2014
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
QUIK-COMBO PACING/DEFIBRILLATION/ECG
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL CORP·Product code LDD·March 31, 1998
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·April 11, 2013
AUTOCAT2 WAVE
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·March 2, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS CORP.·Product code LFR·May 21, 2008
RECAP SHELL COCR PC DIA56/50MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·September 1, 2016