26 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VORTEK URETERAL DOUBLE LOOP STENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Sleeve, Centric
FDA UDI
I.T.S. GmbH·09120047300411·Sleeve, Centric, Proximal Humeral Plate
Aura:fit 5.7
FDA UDI
Sonova AG·07613389736281·
IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
FDA 510(k)
FDA Class 1
·General Hospital
SOF-FLEX MULTI-LENGTH URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·October 24, 2024
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 20, 2013
FREESTYLE FREEDOM LITE
FDA Adverse Event
Malfunction
·Product code NBW·July 27, 2011
PUMP MMT-712NAB PRDGM INSULIN BL EN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·September 26, 2008
SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·September 30, 2024
SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·October 7, 2024
SOF-FLEX MULTI-LENGTH URETERAL STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·October 21, 2024
SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·April 19, 2021
SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·April 19, 2021
SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·June 28, 2022
SOF-FLEX MULTI-LENGTH URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·October 21, 2024
HEARTMATE 3 SYSTEM CONTROLLER
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·July 8, 2022
Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·June 15, 2022
ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 3, 2021
Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·July 13, 2022