9 results
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26ms
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Sources: EU EUDAMED, US FDA
GRASPING TRIPOD FORCEP (MODEL 23/25)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GC Initial™
FDA UDI
Gc America Inc.·J0228740061·GC Initial™ Ti Powder Opaque OB1, 20g
GC Initial™
FDA UDI
Gc America Inc.·15400556704629·GC Initial™ IQ/ Layering-over-Zircon Body D, 50g
BRUCELLA MEDIA
FDA 510(k)
FDA Class 1
·Microbiology
PLASTELAST AND/OR ELASTOPLASTE
FDA 510(k)
FDA Class 1
·General Hospital
PUMP MMT-722NAB PRDGM INS V2.2 BL EN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·October 15, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 21, 2014
6.0MM TI PANGEA(TM) POLYAXIAL SCR DUAL CORE/45MM THRD LENGTH
FDA Adverse Event
Injury
·SYNTHES USA·Product code MNI·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