9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
SURGICAL COTTON GLOVES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HTH®-Right 24mm
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199004250·
EDENTA
FDA UDI
EDENTA ETABLISSEMENT·E312K90044510001·Dowel Pin 15 mm
ISOBAR SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GUIDED LATERAL INTERBODY FUSION (GLIF) SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD .·Product code MCM·June 27, 2014
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·January 7, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 16, 2010
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