11 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Altus Spine Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
ARCHER SUPER STIFF GUIDEWIRES
FDA 510(k)
FDA Class 2
·Cardiovascular
HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)
FDA 510(k)
FDA Class 2
·Hematology
RESTORE ADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 10, 2014
PENTA 60-CM LENGTH PADDLE LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 21, 2011
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 21, 2013
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL MANUFACTURING CORPORATION·Product code MVK·August 4, 2014
SPYSCOPE DS II ACCESS & DELIVERY CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 30, 2020
SPYSCOPE DS II ACCESS & DELIVERY CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 23, 2020
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015