24 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OASIS MRI System
FDA 510(k)
FDA Class 2
·Radiology
Luna
FDA UDI
ULTRADENT PRODUCTS, INC.·00883205003430·Luna Opal R Mini .018 Kit 5x5 U
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551113362·HALO, 1203-5 VEST XX-LARGE, LAMBSWOOL LINER, 12...
BLACKHAWK Cervical Spacer System
FDA UDI
Choice Spine, LP·00840996164429·BLACKHAWK,STERILE,LORDOTIC,14X12X6
BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDOTRACHEAL TUBE WITHOUT CUFF (ORAL/NASAL)
FDA 510(k)
FDA Class 2
·Anesthesiology
SPINAL MESH SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2025
PYRAMESH C TITANIUM MESH
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code EZX·August 12, 2011
PYRAMESH
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code EZX·September 29, 2015
ASTERX EXPANDABLE CORPECTOMY SYSTEM
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code MQP·March 4, 2019
ASTERX EXPANDABLE CORPECTOMY SYSTEM
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code MQP·March 4, 2019
PYRAMESH C TITANIUM MESH
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code EZX·October 26, 2019
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 29, 2014
ETS - ENDOSCOPIC LINEAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 15, 2011
PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·July 8, 2013
PYRAMESH C TITANIUM MESH
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code EZX·June 27, 2020
PYRAMESH C TITANIUM MESH
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code EZX·April 22, 2019
SPACELABS XHIBIT CENTRAL STATION
FDA Adverse Event
Malfunction
·SPACELABS HEALTHCARE INC.·Product code MHX·November 24, 2021
ZEVO ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·December 19, 2018
PYRAMESH® C TITANIUM MESH
FDA Adverse Event
Malfunction
·MEDTRONIC MEDICAL COSTA RICA S.R.L.·Product code EZX·May 26, 2025