26 results · 26ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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