18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP
FDA 510(k)
FDA Class 2
·General Hospital
Safco Royal 4-ply bibs
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310201473·Safco Royal bib 13x18 4ply lvdr 500cs
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·10843717101489·Burs FG 6, Pkg/10
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450157671·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450157657·
NA
FDA UDI
STRYKER CORPORATION·04546540756152·12.0MM TUNNEL DILATOR
CTC DVT-1 CALF GARMENT, MODEL DVT-1
FDA 510(k)
FDA Class 2
·Cardiovascular
FOCUS
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 23, 2024
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code LFR·May 25, 2007
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
GENTEEL HOMECARE PRODUCTS·Product code ITJ·March 25, 2013
NI
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·March 7, 2011
SUPER POLIGRIP EXTRA CARE (ZINC FREE FORMULA)
FDA Adverse Event
Injury
·GLAXOSMITHKLINE DUNGARVAN LTD·Product code KOT·February 28, 2020
SUPER POLIGRIP EXTRA CARE (ZINC FREE FORMULA)
FDA Adverse Event
Injury
·GLAXOSMITHKLINE DUNGARVAN LTD·Product code KOT·January 28, 2020
SUPER POLIGRIP EXTRA CARE (ZINC FREE FORMULA)
FDA Adverse Event
Injury
·GLAXOSMITHKLINE DUNGARVAN LTD·Product code KOT·March 25, 2020
Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·November 2, 2016