9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ELMED LBC 50-P
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668101278·AK STEP KNIFE DOUBLE FOOTPLATE
AVITENE DISPENSER SYRINGE
FDA 510(k)
FDA Class 1
·General Hospital
MINOR LACERATION TRAY W/ INSTRUMENT, STERILE, DISP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AUTOSOFTÂ XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 31, 2024
STELLARIS 25G VIT CUTTER 6/BX
FDA Adverse Event
Malfunction
·BAUSCH & LOMB, INC.·Product code HQC·January 17, 2013
CAPSUREFIX
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 14, 2010
RESTORE
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 10, 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