11 results
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21ms
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Sources: EU EUDAMED, US FDA
MEM-4204-4-8, MEB-4204 &4208 EVOKE POTENT MEAS SYS
FDA 510(k)
FDA Class 2
·Neurology
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909126852·REVELATION DIAMOND 852-012F - 5 PACK
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668110904·TIP GUARDS VENTED ORANGE PACK OF 100
KONICAMINOLTA DI-X1
FDA 510(k)
FDA Class 2
·Radiology
REPROCESSED ENDOSCOPIC ELECTRODES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYNFIX® EVOLUTION AWL/WITHOUT SLEEVE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWJ·September 16, 2016
TECNIS MULTIFOCAL
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code MFK·December 2, 2010
ON-Q PAIN PUMP
FDA Adverse Event
Injury
·I-FLOW, LLC·Product code MEB·January 8, 2013
PINNACLE MTL INS NEUT36IDX56OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·July 3, 2014
SEE H10
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDG·June 4, 2018
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