24 results
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35ms
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Sources: EU EUDAMED, US FDA
ARCTIC BLAST INTRAVENOUS FLUID CHILLER
FDA 510(k)
FDA Class 2
·Cardiovascular
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014608167·STERIS SURGI-GRAPHIC 6000 4.25" SOFTCARE PLUS
PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D
FDA 510(k)
FDA Class 2
·Anesthesiology
C-REACTIVE PROTEIN (CRP)
FDA 510(k)
FDA Class 2
·Immunology
SYRINGE 30ML LL S/C 56
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·July 8, 2024
PARAPAC 'MEDIC' (K020899)
FDA Adverse Event
Death
·SMITHS MEDICAL INTERNATIONAL·Product code BTL·August 6, 2004
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·December 23, 2011
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTL.·Product code MNI·September 16, 2011
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTL.·Product code MNI·October 14, 2011
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·November 11, 2011
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·April 5, 2012
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·April 24, 2013
UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER.
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·May 6, 2011
+4 ENDURON LN 28IDX62 OR 74OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code HRY·July 22, 2008
MEDFUSION® 3500 SYRINGE PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·November 28, 2017
PASS LP
FDA Adverse Event
Injury
·MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013
PASS LP
FDA Adverse Event
Injury
·MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013
PASS LP
FDA Adverse Event
Injury
·MEDICREA·Product code MNI·April 17, 2013
BD SYRINGE 30ML LL S/C 56
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY·Product code FMF·July 8, 2024
Zeiss brand IOLMaster 500, Model 500, 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