20 results · 20ms · Sources: EU EUDAMED, 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