14 results
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34ms
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Sources: EU EUDAMED, US FDA
AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144
FDA 510(k)
FDA Class 1
·Clinical Chemistry
UniTip Catheter
FDA UDI
Unisensor AG·07640172973721·
UniTip Catheter
FDA UDI
Unisensor AG·07640172971826·
uCentum™ comprehensive posterior system
FDA UDI
Ulrich GmbH & Co. KG·04052536083015·Screw, pre-fixation, Ø 10.0 mm, length 60 mm, n...
uCentum™ comprehensive posterior system
FDA UDI
Ulrich GmbH & Co. KG·04052536082988·Screw, pre-fixation, Ø 10.0 mm, length 45 mm, n...
uCentum™ comprehensive posterior system
FDA UDI
Ulrich GmbH & Co. KG·04052536082995·Screw, pre-fixation, Ø 10.0 mm, length 50 mm, n...
uCentum™ comprehensive posterior system
FDA UDI
Ulrich GmbH & Co. KG·04052536083008·Screw, pre-fixation, Ø 10.0 mm, length 55 mm, n...
PRE-CALIBRATED PIPETTES
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CANMED 101
FDA 510(k)
FDA Class 2
·Cardiovascular
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197076111·frame fixed 300 x 240 mm
oval s...
OCTRODE PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·October 21, 2010
PK DISSECTING FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·December 21, 2012
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 19, 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