8 results
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29ms
·
Sources: EU EUDAMED, US FDA
CITRACE HOSPITAL GERMICIDAL DEODORIZER
FDA 510(k)
FDA Class 1
·General Hospital
STERLING INTERFERENC SCREW HT
FDA 510(k)
FDA Class 2
·Orthopedic
IBL 5000 Tanning Booth
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CAREVO
FDA Adverse Event
Injury
·ARJOHUNTLEIGH POLSKA SP. Z O.O.·Product code FNG·June 18, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code NVY·February 9, 2013
CENTRA BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·January 3, 2011
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025; b) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N030; c) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N035; d) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N040
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 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