9 results
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19ms
·
Sources: EU EUDAMED, US FDA
IUD HOOKS
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
USCI SUPER 9 PTCA GUIDING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
BODY-MATE MASSAGER
FDA 510(k)
FDA Class 1
·Physical Medicine
GENTLEMAX
FDA Adverse Event
Malfunction
·CANDELA CORP.·Product code GEX·January 17, 2013
ATTAIN OTW
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 14, 2010
ACCUTRAC (TM) SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code GEX·July 10, 2014
CONTOUR ACETABULAR RECONSTRUCTION RING
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDJ·June 6, 2025
MESH, SURGICAL, ACETABULAR, HIP, PROSTHESIS
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDJ·January 23, 2026
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