34 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5
FDA 510(k)
FDA Class 2
·Cardiovascular
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450448236·
WATCH-PAT 100
FDA 510(k)
FDA Class 2
·Anesthesiology
EVANTGARDE/ENDEAVOR POWERED WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
MAMMARY IMPLANT
FDA Adverse Event
Injury
·MCGHAN MEDICAL CORP.·Product code FTR·September 26, 1995
DUO-VENT CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·September 29, 2022
CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·October 31, 2022
CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·November 1, 2022
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 5, 2023
IMMERSION HYDROBATH
FDA Adverse Event
Malfunction
·INVACARE CLEVELAND STREET·Product code ILJ·May 8, 2013
IBGSTAR BGMS
FDA Adverse Event
Injury
·AGAMATRIX·Product code NBW·September 12, 2014
MICRUS MICROCOIL SYSTEM
FDA Adverse Event
Injury
·MICRUS ENDOVASCULAR CORPORATION·Product code MJN·May 18, 2011
CLEARLINK SOLUTION ADMINISTRATION SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·April 27, 2022
DUO-VENT CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·July 5, 2022
CLEARLINK SOLUTION ADMINISTRATION SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·April 27, 2022
CONTINU-FLO CLEARLINK SYSTEM SOLUTION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·December 29, 2022
FORTRESS INTRODUCER SHEATH SYSTEM - 6FR, 45CM
FDA Adverse Event
Malfunction
·CONTRACT MEDICAL INTERNATIONAL GMBH·Product code DYB·November 30, 2015
Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018
Brilliance iCT - Model 728306 Computed Tomography X-ray systems
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·January 31, 2018
IVEA Product Part Number 16100 Model 500A
FDA Enforcement
Class II
·Terminated·Firefly Medical, Inc.·October 11, 2017