15 results
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24ms
·
Sources: EU EUDAMED, US FDA
FO92 SEATING MASSAGER
FDA 510(k)
FDA Class 1
·Physical Medicine
ACS CHOLESTEROL/TRIGLYCERIDE LIQUID CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LYPHOCHEK BENZO/TCA CONTROL SERUM, LEVELS 1 AND 2
FDA 510(k)
FDA Class 1
·Clinical Toxicology
PINNACLE SECTOR II CUP 54MM
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·August 26, 2013
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·8010379 DEPUY INTL., LTD.·Product code JDI·August 26, 2013
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·8010379 DEPUY INTL., LTD.·Product code KWA·August 26, 2013
KEEPSAFE DELUXE
FDA Adverse Event
Malfunction
·J. T. POSEY CO.·Product code KMI·December 7, 2012
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·December 4, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 4, 2014
SUMMIT POR TAPER SZ7 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·April 3, 2013
PINNACLE 100 ACET CUP 58MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·April 3, 2013
PINNACLE MTL INS NEUT36IDX58OD
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code KWA·October 27, 2012
PINNACLE MTL INS NEUT36IDX56OD
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code KWA·October 27, 2012
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code JDI·October 27, 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