11 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533
FDA 510(k)
FDA Class 1
·Dental
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032756·Baltic Denture System BDLoad Sw7 PLSEbm6DFs A1 ...
NIPRO BIO-FLEX CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
EASE-A-CULT
FDA 510(k)
FDA Class 2
·Hematology
MOSAIC
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code DYE·December 11, 2025
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·April 3, 2013
MPS DELIVERY SET
FDA Adverse Event
Malfunction
·QUEST MEDICAL·Product code DTR·February 23, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·April 22, 2008
TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01
FDA Enforcement
Class II
·Terminated·ArthroCare Corporation·April 13, 2016
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018