10 results
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26ms
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Sources: EU EUDAMED, US FDA
HOLLOW ALLIGATOR GRASPING FORCEP (MODEL 18/12)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GC Initial™
FDA UDI
Gc America Inc.·J0228740031·GC Initial™ Ti Powder Opaque OA3, 20g
GC Initial™
FDA UDI
Gc America Inc.·15400556704599·GC Initial™ IQ/ Layering-over-Zircon Body A, 50g
ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH
FDA 510(k)
FDA Class 2
·Cardiovascular
MOTILITY INDOLE ORNITHINE-MEDIUM
FDA 510(k)
FDA Class 1
·Microbiology
Span-America
FDA UDI
SPAN-AMERICA MEDICAL SYSTEMS, INC.·H93300387400300·ZIMMER SKIN TRAC ADULT 300/CS
RHEAD RECON RADIAL HEAD IMPLANT
FDA Adverse Event
Injury
·SMALL BONE INNOVATIONS, INC.·Product code KWI·June 5, 2014
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 19, 2010
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·December 14, 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