13 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OMNI PLANE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DRAGER PEEP SYSTEM D
FDA 510(k)
FDA Class 2
·Anesthesiology
uCentum™ comprehensive posterior system
FDA UDI
Ulrich GmbH & Co. KG·04052536082957·Screw, pre-fixation, Ø 8.5 mm, length 50 mm, no...
uCentum™ comprehensive posterior system
FDA UDI
Ulrich GmbH & Co. KG·04052536082971·Screw, pre-fixation, Ø 8.5 mm, length 60 mm, no...
uCentum™ comprehensive posterior system
FDA UDI
Ulrich GmbH & Co. KG·04052536082964·Screw, pre-fixation, Ø 8.5 mm, length 55 mm, no...
uCentum™ comprehensive posterior system
FDA UDI
Ulrich GmbH & Co. KG·04052536082940·Screw, pre-fixation, Ø 8.5 mm, length 45 mm, no...
uCentum™ comprehensive posterior system
FDA UDI
Ulrich GmbH & Co. KG·04052536082933·Screw, pre-fixation, Ø 8.5 mm, length 40 mm, no...
uCentum™ comprehensive posterior system
FDA UDI
Ulrich GmbH & Co. KG·04052536082926·Screw, pre-fixation, Ø 8.5 mm, length 35 mm, no...
EON IPG
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, NEUROMODULATION DIVISION·Product code LGW·October 21, 2010
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·December 21, 2012
SUR-FIT NATURA 2 PC DURAHESIVE MOLDABLE WAFER
FDA Adverse Event
Injury
·CONVATEC INC.·Product code EXE·June 9, 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