14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Consensus Knee System Modular Tibial Baseplate
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814282·GENUMEDI PT SILVER R V
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613061012·Wiener Antrum Rasp, Trocar Tip, 4mm Diameter, C...
Temporary Abutment
FDA UDI
BICON, LLC·00813110028730·4.0 x 2.5mm Scannable Temporary Abutment - 2.0m...
VIRTUOST
FDA 510(k)
FDA Class 2
·Radiology
FASTPACK CONTROL KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·UNKNOWN·Product code FSA·June 3, 2013
SECURE ACUTE CARE BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·June 3, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 6, 2014
5.0MM TI SIDE-OPENING SCREW 40MM
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MNI·June 5, 2012
5.0MM TI SIDE-OPENING SCREW 40MM
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MNI·June 5, 2012
TI NUT 11MM WIDTH ACROSS FLATS
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MNI·June 5, 2012
TI NUT 11MM WIDTH ACROSS FLATS
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MNI·June 5, 2012
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·December 9, 2015