10 results
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26ms
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Sources: EU EUDAMED, US FDA
MODIFIED SOFTWARE TO THE SONOS 100 ULTRASOUND
FDA 510(k)
FDA Class 2
·Cardiovascular
XLR
FDA UDI
Nuvasive, Inc.·00887517388629·XLR Trial, 20x38x28 8° Detachable
VICTORY XL 130 FOUR WHEEL SCOOTER, MODEL SC713
FDA 510(k)
FDA Class 2
·Physical Medicine
SHAVER ABLATOR
FDA 510(k)
FDA Class 2
·Orthopedic
SYMBIQ SINGLE CHANNE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 2, 2014
PINNACLE SECTOR II CUP 50MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·November 10, 2010
SCREW
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 8, 2013
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the 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. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013