8 results
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19ms
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Sources: EU EUDAMED, US FDA
PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE
FDA 510(k)
FDA Class 2
·Dental
JOSEPH HOOK
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896099463·JOSEPH HOOK SHARP PRONGS ROUND HANDLE BLUE ELEC...
R-800-SF
FDA 510(k)
FDA Class 1
·Radiology
IMX TOTAL B-HCG
FDA 510(k)
FDA Class 2
·Clinical Chemistry
UNKNOWN DEPUY PRODIGY FEMORAL HIP STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code MEH·March 8, 2013
ENDEAVOR RESOLUTE RX
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NIQ·August 8, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 12, 2015
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