21 results
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28ms
·
Sources: EU EUDAMED, US FDA
SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES
FDA 510(k)
FDA Class 2
·Radiology
GRADIA®
FDA UDI
Gc America Inc.·14548161292351·GRADIA® STANDARD SET 6 SHADES
GRADIA®
FDA UDI
Gc America Inc.·D0470015171·GRADIA® STANDARD SET 6 SHADES
ActivHeal
FDA UDI
ADVANCED MEDICAL SOLUTIONS LIMITED·15032749001514·SILICONE FOAM BORDER 15x15CM
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001517·artVeneer life lower anteriors, UCS, D4
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515309739·Sponge Bowl, 20oz 5" x 2 3/8"
Sonova Brand
FDA UDI
Sonova AG·07613389431698·Easy Line Remote 3.0 app
LIFE SCOPE EC, MODEL BSM-1102
FDA 510(k)
FDA Class 2
·Cardiovascular
RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC
FDA 510(k)
FDA Class 2
·General Hospital
UniTip Catheter
FDA UDI
Unisensor AG·07640172971659·
PROFEMUR(R) MODULAR FEMORAL NECK
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LWJ·November 12, 2012
DYNASTY(R) COCR LINER
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code JDL·November 12, 2012
PROFEMUR(R) RENAISSANCE(R)
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code JDL·November 12, 2012
CONSERVE(R) TOTAL A-CLASS
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code JDL·November 12, 2012
iBOT PMD with software version 01.05.24. Personal Mobility Device.
FDA Enforcement
Class II
·Ongoing·Mobius Mobility LLC·June 18, 2025
CLINITEK ATLAS
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code KQO·March 5, 2013
WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code MQR·February 25, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·February 20, 2008
Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
FDA Enforcement
Class II
·Terminated·ArthroCare Corporation·September 30, 2020
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025