8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 AND VS3
FDA 510(k)
FDA Class 2
·Cardiovascular
Tinnitus Sound Generator Module
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
EPIC PLUS VR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014
FMP HIP LINER
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code LPH·October 13, 2010
UNKNOWN DEPUY ASR FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.8010379·Product code JDI·December 19, 2012
2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Mandible Locking Plates.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·February 4, 2015
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