7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIMENSION AHDL CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MSI-CAL 16
FDA 510(k)
FDA Class 2
·Hematology
EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS
FDA 510(k)
FDA Class 2
·Immunology
QUICKFLEX XL LV LEAD
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·February 28, 2013
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·February 10, 2011
6.5CM ADULT CRANI ATTACHMT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·December 18, 2013
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019