8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
DADE(R) IMMUNOADSORBED FACT V DEF PLASMA (HUMAN)
FDA 510(k)
FDA Class 2
·Hematology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450286586·
REPROCESSED RF ARTHROSCOPY PROBES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ON-Q PAIN PUMP
FDA Adverse Event
Injury
·I-FLOW, LLC·Product code MEB·January 8, 2013
NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
FDA Adverse Event
Injury
·HOLOGIC·Product code MNB·November 24, 2010
HYDRA JAGWIRE?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code EZB·July 3, 2014
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