11 results
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18ms
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Sources: EU EUDAMED, US FDA
ANESTHESIA BREATHING CIRCUITS
FDA 510(k)
FDA Class 1
·Anesthesiology
TCP
FDA UDI
WRIGHT MEDICAL TECHNOLOGY, INC.·00840420118073·
ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC
FDA 510(k)
FDA Class 2
·Cardiovascular
DIXI 2
FDA 510(k)
FDA Class 2
·Dental
PRIMEADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 27, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 7, 2013
PENUMBRA SYSTEM REPERFUSION CATHETER 032
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·October 26, 2010
SMR CEMENTLESS FINNED STEM
FDA Adverse Event
Injury
·LIMACORPORATE SPA·Product code HSD·September 15, 2021
SMR GLENOID PEG TT SMALL-R #L
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWS·March 18, 2022
Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code JJE·November 19, 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