9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HOLLISTER VERTICAL DRAIN/TUBE ATTACHMENT DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Edge™ Diamond TS012-8SC Tapered Shoulder
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172003551·Diamond dental bur, reusable
HEARTWAY POWER MOBILITY SCOOTER
FDA 510(k)
FDA Class 2
·Physical Medicine
STRYKER SPINE MAPS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ADVIA CENTAUR TOTAL HCG (THCG) AND PROGESTERONE
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JHI·March 5, 2010
CORAL REEF GAIT BELT LONG
FDA Adverse Event
Malfunction
·J. T. POSEY CO.·Product code IKX·March 11, 2014
CONSULTA
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NIK·December 20, 2010
EYE SURGERY STRETCHER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·December 28, 2012
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