9 results
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34ms
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Sources: EU EUDAMED, US FDA
EASYSTAT SODIUM/POTASSIUM ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704286274·
ODONTIT OSSEOINTEGRATED IMPLANTS SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ACCENT DG BALLOON URETERAL DILATOR SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KAPPA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code DXY·February 11, 2013
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·January 10, 2011
NEURON 6F 070 DELIVERY CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DQY·July 24, 2014
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
FDA Enforcement
Class I
·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021
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