7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RPR TEST FOR SYPHILIS IN SERUM OR PLASMA
FDA 510(k)
FDA Class 2
·Microbiology
Straumann PURE Ceramic Implant System
FDA 510(k)
FDA Class 2
·Dental
PHYSIOLOGICAL PRESSURE TRANSDUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
SINGLE DELUXE BREASTPUMP
FDA Adverse Event
Other
·MEDELA, INC.·Product code HGX·October 13, 2010
ATLAS PLUS HF CRT-D
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code NIK·January 13, 2014
VITROS CHEMISTRY PRODUCTS PHBR SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code DLZ·December 19, 2012
Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025