8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
UNIPOLAR HOOK ELECTRODE (5MM .340MM)/UNIPOLAR HOOK ELECTRODE (5MM. 420MM)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODELS 54601/54602/54603/54604 NEEDLE & BIOPSY KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY
FDA 510(k)
FDA Class 1
·Microbiology
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWP·August 30, 2012
PULSE GEN MODEL 103
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·February 15, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 29, 2014
ONE STEP BUTTON¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KGC·January 19, 2011
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