8 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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LAPAROSCOPIC CURVED TRIANGLE RETRACTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NOVA ONE BLOOD GLUCOSE MONITOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
507EL VITAL SIGNS MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
BARDIA FOLEY CATHETER SILICONE COATED K922431
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON) -1018233·Product code KOD·November 1, 2021
HICKMAN 7FR DL CVC, PEEL-APART INTRO WITH SURCE CUFF
FDA Adverse Event
Malfunction
·BARD ACCESS SYSTEMS·Product code LJS·June 3, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 18, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010
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