21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AngioDynamics Mariner Angiographic Catheters
FDA 510(k)
FDA Class 2
·Cardiovascular
Endo-Model Knee System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575298259·Knee femur prosthesis trial - General Instrument
Endo-Model Knee System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575297443·Knee femur prosthesis trial - General Instrument
Endo-Model Knee System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575297016·Knee femur prosthesis trial - General Instrument
Endo-Model Knee System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575298013·Knee femur prosthesis trial - General Instrument
LinkSymphoKnee - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575239917·Orthopaedic prosthesis implantation instrument,...
MaxFuse,VBR, 12 (D) x 14 (W) x 18 (H)
FDA UDI
Pioneer Surgical Technology, Inc.·00846468055981·VBR, 12 (D) x 14 (W) x 18 (H)
LinkSymphoKnee - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575240432·Orthopaedic prosthesis implantation instrument,...
STRAUMANN TIBRUSH
FDA 510(k)
FDA Class 2
·Dental
ACUMEN IMAGE GUIDED SURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
PASSEO-18 5/200/90
FDA Adverse Event
Malfunction
·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021
PASSEO-18 6/200/90
FDA Adverse Event
Malfunction
·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021
PASSEO-18 2.5/170/130
FDA Adverse Event
Malfunction
·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·January 20, 2021
CONTOUR® NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code JJX·September 4, 2025
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 6, 2011
SECURA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 7, 2013
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
AERO LL FIXATION ANCHOR, 50MM
FDA Adverse Event
Malfunction
·STRYKER SPINE-US·Product code OVD·March 25, 2019
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code JJX·February 20, 2025
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013