10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IMS
FDA UDI
Avalign Technologies, Inc.·00190776147693·Markham Meyerding Retractor self-retaining, lef...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776147631·Markham-Meyerding Retractor- Right
AMOENA AFFINITY MODEL #802
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SCRIBBON
FDA 510(k)
FDA Class 1
·Dental
PLM A+ SPANISH DEVIC
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·June 12, 2014
SPRINT QUATTRO
FDA Adverse Event
Injury
·MPRI·Product code LWS·February 11, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·January 10, 2011
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
FDA Enforcement
Class I
·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021
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