18 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACTICOAT 7 DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
TruForm
FDA UDI
Rmo, Inc.·00885797099716·MD MLR BDS R/L SE ASIA ASST100
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001519·artVeneer life lower anteriors, UBL, D4
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756131889·Custom Anesthesia Circuit
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515008847·Sponge Bowl, 38oz 6.25" x 2.75"
Sonova Brand
FDA UDI
Sonova AG·07613389431704·Easy Line Remote 3.0 app
TI500 GLOBE-TROTTER TRANSPORT SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
GLUCANPRO
FDA 510(k)
FDA Unclassified
·Unknown
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·March 26, 2014
FREESTYLE
FDA Adverse Event
Injury
·Product code NBW·October 26, 2010
iBOT PMD with software version 01.05.24. Personal Mobility Device.
FDA Enforcement
Class II
·Ongoing·Mobius Mobility LLC·June 18, 2025
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·November 10, 2016
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 5, 2013
LUPINE DRILL BIT
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code HTW·January 26, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·February 20, 2008
TECNIS SIMPLICITY
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code POE·May 28, 2025
Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
FDA Enforcement
Class II
·Terminated·ArthroCare Corporation·September 30, 2020
CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·April 17, 2019