20 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TERUMO GAS FILTER
FDA 510(k)
FDA Class 2
·Anesthesiology
Safco FG Diamonds
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310210203·FG Diamond 801-012 ball regular ss 5/pack
ROLLO 210X30X19I.MM
FDA UDI
AB MEDICA GROUP, S.A.·08428763005711·
Humeris Shoulder
FDA UDI
FX SOLUTIONS·03701037304563·TRIAL HUMERIS STEM T20
Caplugs/Evergreen
FDA UDI
CAPlugs·00810044200683·Cups for BBL Fibrometer
DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
8100 VITAL SIGNS MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·February 8, 2021
BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·February 16, 2021
SOLETRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·April 23, 2010
Materialise Personalized Solutions
FDA UDI
Materialise NV·05420060343391·Upper Extremity Guide and Model
Materialise Personalized Solutions
FDA UDI
Materialise NV·05420060343407·Lower extremity Guide and Model
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·December 16, 2016
PICC KIT: 4 FR X 21-1/2IN (55 CM)
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code LJT·March 20, 2013
SPRINT FIDELIS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 16, 2011
CYPHER CLINICAL 2.50 X 23MM
FDA Adverse Event
Injury
·CORDIS EUROPA, N.V.·Product code NIQ·March 26, 2008
13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastroparesis.
FDA Enforcement
Class II
·Terminated·Cairn Diagnostics·February 24, 2021
SYRINGE 3ML LL 200 S/C
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·April 1, 2020
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014