16 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RANGE SPINAL SYSTEM, SMALL STATURE
FDA 510(k)
FDA Class 2
·Orthopedic
Simpliciti™
FDA UDI
TORNIER, INC.·00846832061273·
Tornier Simpliciti® Shoulder System
FDA UDI
TORNIER, INC.·00846832092055·
COMEN MULTI-PARAMETER PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
OBSERVER ULTRASOUND REPORTING AND IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·May 21, 2013
PARADIGM REAL-TIM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 18, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 14, 2011
14 SHIDEN HP
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·September 26, 2024
MGIT SERIES 960 AST SIRE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code MJA·July 21, 2025
MGIT SERIES 960 AST SIRE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code MJA·December 21, 2023
14 SHIDEN HP
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·February 4, 2025
14 SHIDEN HP
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·February 13, 2025
14 SHIDEN HP
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·June 20, 2025
Brilliance 64 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 8, 2016
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024