12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PROTEMP II
FDA 510(k)
FDA Class 2
·Dental
3M™ Unitek™
FDA UDI
3M COMPANY·30605861028739·3M™ Unitek™ Stainless Steel Second Permanent Mo...
Imaging Plates
FDA UDI
PaloDEx Group Oy·06430035874996·STD IP-SET 0X6 DT-1
EDENTA
FDA UDI
EDENTA ETABLISSEMENT·E312K90044610001·Dowel Pin 12 mm
Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746135743·DB BKT MASTER LR CUSP 018 T-6 A+3 R2D
TCP
FDA UDI
WRIGHT MEDICAL TECHNOLOGY, INC.·00840420118837·
BELLEGLASS HP TRANSLUCENT DENTIN
FDA 510(k)
FDA Class 2
·Dental
AIRWAYEASE MAS
FDA 510(k)
FDA Class 2
·Dental
PULSE GEN MODEL 102R
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·June 27, 2014
SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Injury
·DEXCOM INC.·Product code MDS·January 7, 2013
TERUMO TCM II COOLING AND HEATING SYSTEM
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DWC·October 28, 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