7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
OPERATING MICROSCOPE AA OM 10
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
BD SHIELDED CATHETER, INSYTE AUTOGUARD 20 GA 1.16 IN 1.1 X 30 MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code FOZ·January 29, 2013
EXODUS BILIARY CATHETER 10 FR
FDA Adverse Event
Injury
·NAVILYST MEDICAL·Product code FGE·December 21, 2010
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code FSA·July 17, 2014
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