61 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HAPTOGLOBIN NEPHELOMETRIC ASSAY
FDA 510(k)
FDA Class 2
·Immunology
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551201879·Retractor 60 mm x 30 mm
ACUMED
FDA UDI
Acumed LLC·10806378049255·3.2mm x 300mm Ball Tip Guide Wire
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209134427·
EK/P. AERUGINOSA PNA FISH
FDA 510(k)
FDA Class 1
·Microbiology
CNS-9300 SERIES CENTRAL STATION
FDA 510(k)
FDA Class 2
·Cardiovascular
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 8, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 23, 2012
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 28, 2015
Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Recall
Terminated
·Atrium Medical Corporation·Product code DSY·August 25, 2021
Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBZ·June 19, 2015
Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S. only) Atrium Advanta V12 Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85355 (Marketed OUTSIDE U.S. only) The iCAST Covered Stent is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.
FDA Recall
Terminated
·Atrium Medical Corporation·Product code JCT·May 25, 2017
Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Recall
Terminated
·Atrium Medical Corporation·Product code DSY·July 12, 2013
Advanta SST Bifurcated Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Recall
Terminated
·Atrium Medical Corporation·Product code DSY·July 12, 2013
Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Recall
Terminated
·Atrium Medical Corporation·Product code DYF·July 12, 2013
Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Recall
Terminated
·Atrium Medical Corporation·Product code DSY·July 12, 2013
Advanta VS Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Recall
Terminated
·Atrium Medical Corporation·Product code DSY·July 12, 2013
Advanta VS Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Recall
Terminated
·Atrium Medical Corporation·Product code DYF·July 12, 2013
Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Recall
Terminated
·Atrium Medical Corporation·Product code DSY·July 12, 2013
Advanta SuperSoft Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Recall
Terminated
·Atrium Medical Corporation·Product code DSY·July 12, 2013