10 results
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24ms
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Sources: EU EUDAMED, US FDA
C-TERMINAL PTH RIA TEST KIT, DSL-1000
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Preat
FDA UDI
Preat Corporation·00842092133613·Sphero Block Abutment Camlog 3.3 x 3mm (2.5mm B...
Perfect Fit
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377021572·Perfect Fit™ 3D REUSABLE-Disposable Kit include...
SONY LMD-2451MT LCD MONITOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·August 7, 2023
TERUMO PERFUSION SYSTEM 8000
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DTQ·March 26, 2014
ATTAIN ABILITY
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·October 31, 2012
ALARIS SE PUMP ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORP.·Product code FPA·August 19, 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