16 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Electric Scooter
FDA 510(k)
FDA Class 2
·Physical Medicine
NuVasive
FDA UDI
Nuvasive, Inc.·00195377105165·NTS Slot Tube, 20x90mm Beveled
Ti-Fix OLIF Spacer
FDA UDI
Tyber Medical, LLC·M695P32120900·Ti-Fix OLIF Spacer 32 x 12 x 9 (mm) x 0 °
HONOUR™ Spacer System
FDA UDI
NEXXT SPINE, LLC·00889929002872·Cervical PEEK, 6°, 12mm W x 12mm D x 9mm H
HONOUR™ Spacer System
FDA UDI
NEXXT SPINE, LLC·00889929002889·Cervical PEEK, 0°, 12mm W x 12mm D x 9.0mm H
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BAHADIR STERILIZATION TRAYS
FDA 510(k)
FDA Class 2
·General Hospital
INSYTE AUTOG BC WING PNK 20GA X1.16IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·May 20, 2020
EVAC 70 XTRA COBLATOR II
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC.·Product code GEI·August 30, 2018
ENDO GIA ROTICULATOR 60-3.5 SULU
FDA Adverse Event
Injury
·NORTH HAVEN - USS·Product code GDW·October 23, 2008
LIGASURE ATLAS HANDSWITCHING 37CM
FDA Adverse Event
Malfunction
·COVIDIEN LLC (SHANGHAI)·Product code GEI·July 8, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 8, 2013
FISCHER CONE BIOP EX LG S
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code HGI·June 3, 2019
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025