9 results
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25ms
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Sources: EU EUDAMED, US FDA
MENTOR MODIFIED MALLEABLE PENILE PROSTHESES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Well at Walgreens
FDA UDI
WALGREEN CO.·00311917207018·WAG Deluxe Wrist GEN5
Hygiene bag FL for Imaging Plate Systems SIZE 1 200PCS
FDA UDI
PaloDEx Group Oy·06430035873173·
SPY INTRA-OPERATIVE IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
ENDURANT
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·June 27, 2014
ADVIA CENTAUR CP TROPONIN ULTRA ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·January 7, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 26, 2010
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