19 results
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21ms
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Sources: EU EUDAMED, US FDA
ORAL NEUTRALIZER
FDA 510(k)
FDA Unclassified
·Unknown
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496071617·STRIPE GAME CASSIOPEA, SIZE S, NERO, GRADUATED ...
LIFEJET PRINTER 400
FDA 510(k)
FDA Class 2
·Radiology
C.T.M. POWER CHAIR, MODEL HS-2800
FDA 510(k)
FDA Class 2
·Physical Medicine
VERCISE GEVIA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·March 4, 2021
UNK - SCREW
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code KWQ·July 26, 2011
UNK - SCREW
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code KWQ·July 26, 2011
UNK - SCREW
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code KWA·July 26, 2011
UNK - SCREW
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code KWQ·July 26, 2011
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·April 22, 2013
DORNIER HOLMIUM FIBER
FDA Adverse Event
Malfunction
·DORNIER MEDTECH AMERICA, INC.·Product code GEX·August 12, 2014
POSEY ENCLOSURE BED
FDA Adverse Event
Injury
·JT POSEY CO.·Product code FMQ·July 8, 2008
IRIDEX IQ577 LASER SYSTEM
FDA Adverse Event
Injury
·IRIDEX CORP.·Product code GEX·November 4, 2013
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·October 7, 2020
Zeiss brand IOLMaster 500, Model 500, 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
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for 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.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·December 9, 2015
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022