9 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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THORA-CATH
FDA 510(k)
FDA Class 2
·General Hospital
Brigade
FDA UDI
Nuvasive, Inc.·00887517327970·Brigade, 12x34x32 8°
APTUS ULNA SHORTENING 2.5
FDA 510(k)
FDA Class 2
·Orthopedic
GETTIG UNIVERSAL VIAL ACCESS PIN
FDA 510(k)
FDA Class 2
·General Hospital
PLUM A+ UK WITH 3PIN
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·January 18, 2013
DUPLO-CATH MIS
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - VIENNA·Product code FMF·December 29, 2010
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·July 17, 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
Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)
FDA Enforcement
Class II
·Terminated·Philips North America Llc·November 17, 2021