13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NeuroBlate System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MONTERIS MEDICAL NEUROBLATE SYSTEM
FDA Adverse Event
Malfunction
·MONTERIS MEDICAL CORPORATION·Product code GEX·April 22, 2015
HUMERAL NAIL
FDA UDI
Biomet Orthopedics, LLC·00887868004858·
IOS EXTERNAL FIXATOR, MODEL 2-0-0
FDA 510(k)
FDA Class 2
·Orthopedic
OSSEOTITE II MODEL XIFOSSXXX
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 17, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 2, 2025
CUSA EXCEL 23KHZ TUBING SET
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES(IRELAND)·Product code LFL·October 5, 2018
ECHELON*FLEX45
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 14, 2013
BIRD
FDA Adverse Event
Malfunction
·CAREFUSION·Product code BZR·June 22, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code NIQ·September 15, 2008
F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top frame, arm supports,
FDA Enforcement
Class II
·Terminated·Allen Medical Systems·April 4, 2018
AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022