8 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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AIRCAST VENAFLOW SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS
FDA 510(k)
FDA Class 2
·Cardiovascular
TI COLLAR WITH GROOVES
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code MNI·July 24, 2017
ALTRX +4 NEUT 40IDX58OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·January 29, 2013
PUMP MMT-722LNAP PRDGM INS PL EN ML
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·December 14, 2010
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 14, 2014
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