12 results
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26ms
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Sources: EU EUDAMED, US FDA
PDA SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SOLE MEDIAL COLUMN FUSION PLATE
FDA UDI
ORTHOFIX SRL·18053340348232·SS NON-LOCKING SCREW L22MM D5MM
LEONE SPA
FDA UDI
LEONE SPA·08033707064992·TUBE MIM CONV 22/51 OCC T-10 R+8 UR
SOLE MEDIAL COLUMN FUSION PLATE
FDA UDI
ORTHOFIX SRL·18053340347075·SS NON-LOCKING SCREW L22MM D5MM STERILE
JAUNDICE METER, MODEL JM 103
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Second Opinion CC
FDA 510(k)
FDA Class 2
·Radiology
UNKNOWN_KIE_PRODUCT
FDA Adverse Event
Injury
·STRYKER TRAUMA KIEL·Product code HSB·June 2, 2014
CONTOUR NEXT
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·November 21, 2012
MINNTECH
FDA Adverse Event
Other
·MINNTECH CORP·Product code FEB·September 20, 2010
XVWEB
FDA Adverse Event
Injury
·PLANET DDS·Product code LLZ·March 13, 2025
SECOND OPINION
FDA Adverse Event
Injury
·PEARL INC.·Product code MYN·March 13, 2025
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