13 results
·
19ms
·
Sources: EU EUDAMED, US FDA
RANEY CLIPS
FDA 510(k)
FDA Class 2
·Neurology
TLX
FDA UDI
Nuvasive, Inc.·00887517730404·TLX Implant, 8x11x27mm 15°
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575534524·Knee tibia prosthesis trial - LinkSymphoKnee
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575534517·Knee tibia prosthesis trial - LinkSymphoKnee
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575534494·Knee tibia prosthesis trial - LinkSymphoKnee
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575534500·Knee tibia prosthesis trial - LinkSymphoKnee
THAI NIPPON MALE LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
WHITE BLOOD CELL COUNT CONTROL LEVELS
FDA 510(k)
FDA Class 2
·Hematology
AO HANDLE TORQ LIMITING 3.0NM
FDA Adverse Event
Malfunction
·DEPUY SPINE INC·Product code LXH·February 9, 2021
V60 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code MNT·June 18, 2014
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·October 6, 2010
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON INC·Product code FTL·December 20, 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