8 results
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19ms
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Sources: EU EUDAMED, US FDA
COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE
FDA 510(k)
FDA Class 1
·Physical Medicine
VARIAX DISTAL FIBULA PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
RABBIT ANTIBODY TO HUMAN T3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·October 6, 2010
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 17, 2012
ETHILON NYLON SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAR·June 18, 2014
The Bigger Better-Bladder, Catalog Number BBB38 (with 3/8 inch ID tubing), Sterile, Single use only --- Manufactured for: Circulatory Technology Inc., 21 Singworth Street, Oyster Bay, 11771 (516) 624-2424 --- 510 (k) 981284.
FDA Recall
Terminated
·Circulatory Technology Inc·Product code DTN·June 3, 2009
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