11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CareView 1800Cw X-ray Flat Panel Detectors
FDA 510(k)
FDA Class 2
·Radiology
UniTip Catheter
FDA UDI
Unisensor AG·07640172971376·
END CAP T2 HUMERUS 6MM, 5MM HEIGHT
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·December 18, 2012
PM-60 PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OCTRODE LEAD, 60CM LENGTH
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 20, 2011
ETS FLEX ARTICNG LNR CUTR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 17, 2013
TALENT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC CARDIOVASCULAR·Product code MIH·September 19, 2008
ACCOLADE PLUS TMZF HIP STEM #4
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·August 5, 2019
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
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