11 results
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17ms
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Sources: EU EUDAMED, US FDA
GAP-IGG
FDA 510(k)
FDA Class 1
·Microbiology
3M™ Unitek™
FDA UDI
3M COMPANY·30605861028531·3M™ Unitek™ Stainless Steel First Permanent Mol...
Ortho Specialties
FDA UDI
Young Innovations, Inc.·00843471163221·Comfort Hook™ First Molar Weldable Convertible ...
Denovo Stainless Steel Permanent Molar Crown
FDA UDI
Denovo Dental, Inc.·00810059294103·Denovo Stainless Steel Permanent Molar Crown - ...
NAC Y-ADP
FDA 510(k)
FDA Class 2
·General Hospital
SENTINEL SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HIP END EFFECTOR, VARIABLE ANGLE
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·October 30, 2015
ESSURE
FDA Adverse Event
Injury
·BAYER·Product code HHS·June 27, 2014
ARDIS
FDA Adverse Event
Malfunction
·ZIMMER SPINE·Product code MAX·October 26, 2010
GALAXY INTRAVASCULAR ULTRASOUND SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code IYO·January 7, 2013
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