8 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MAGEC® Spinal Bracing and Distraction System
FDA 510(k)
FDA Class 2
·Orthopedic
DIMENSION VISTA SYSTEM UCFP CALIBRATOR, MODEL KC260
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR
FDA 510(k)
FDA Class 2
·Radiology
BRIGHTVIEW XCT IMAGING SYSTEM
FDA Adverse Event
PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.·Product code KPS·June 6, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·February 17, 2011
CAPSURE
FDA Adverse Event
Injury
·MPRI·Product code DTB·October 10, 2014
VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser System for Refractive Correction. Catalog Number 0000000-1345-518 Product Usage: The VisuMax Femtosecond Laser is a precision ophthalmic surgical laser designed for the creation of incisions in the cornea. The VisuMax Femtosecond Laser is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia. This device is intended for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia >=-1.00 D to <=-8.00 D, with <=-0.50 D cylinder and MRSE <=-8.25 D in the eye to be treated in patients who are 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change of <=0.50 D MRSE.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec, Inc.·December 25, 2019
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021