12 results
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27ms
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Sources: EU EUDAMED, US FDA
BIOTROL CK MONOEACTIF
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575534562·Knee tibia prosthesis trial - LinkSymphoKnee
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575534555·Knee tibia prosthesis trial - LinkSymphoKnee
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575534548·Knee tibia prosthesis trial - LinkSymphoKnee
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575534531·Knee tibia prosthesis trial - LinkSymphoKnee
LONG NAIL KIT R2.0, TI, LEFT GAMMA3 11 X 360MM X 12
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·June 6, 2012
RED BLOOD CELL COUNT & HEMATOCRIT CNTL
FDA 510(k)
FDA Class 2
·Hematology
HYGEIA-5 OXYGEN CONCENTRATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·February 18, 2014
X8000 LIGHTSOURCE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·October 18, 2010
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·November 14, 2012
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