20 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XN CHECK
FDA 510(k)
FDA Class 2
·Hematology
INTRABEAM NEEDLE APPLICATOR
FDA 510(k)
FDA Class 2
·Radiology
EDGE CO2 LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 10, 2013
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·July 6, 2011
SARNS CENTRIFUGAL PUMP
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code KFM·September 11, 2008
INDY OTW VASCULAR RETRIEVER
FDA Adverse Event
Injury
·COOK INC·Product code MMX·December 23, 2016
INDY OTW VASCULAR RETRIEVER
FDA Adverse Event
Injury
·COOK INC·Product code MMX·March 23, 2017
INDY OTW VASCULAR RETRIEVER
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·October 24, 2016
THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS)
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·October 20, 2025
INDY OTW VASCULAR RETRIEVER
FDA Adverse Event
Injury
·COOK INC·Product code MMX·February 20, 2019
INDY OTW VASCULAR RETRIEVER
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·October 29, 2018
INDY OTW VASCULAR RETRIEVER
FDA Adverse Event
Injury
·COOK INC·Product code MMX·August 3, 2018
INDY OTW VASCULAR RETRIEVER
FDA Adverse Event
Injury
·COOK INC·Product code MMX·September 7, 2016
INDY OTW VASCULAR RETRIEVER
FDA Adverse Event
Injury
·COOK INC·Product code MMX·April 30, 2018
INDY OTW VASCULAR RETRIEVER
FDA Adverse Event
Injury
·COOK INC·Product code MMX·April 14, 2017
INDY OTW VASCULAR RETRIEVER
FDA Adverse Event
Injury
·COOK INC·Product code MMX·June 14, 2018
INDY OTW VASCULAR RETRIEVER
FDA Adverse Event
Injury
·COOK INC·Product code MMX·April 20, 2017
GMK-PRIMARY FEMUR CEMENTED PS SIZE 4NARROW / RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 20, 2017
various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·April 26, 2017