14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sydney IVF Gamete Buffer
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ECG Module(AHA)
FDA UDI
SAMSUNG MEDISON CO., LTD.·08806167712532·
ENDOSSEOUS DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
SINGLE USE BILIARY DRAINAGE STENT V
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ELLIPSE VR, DF-4 CONNECTOR
FDA Adverse Event
Death
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·October 8, 2014
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DXY·June 8, 2013
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·June 21, 2011
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code KRD·November 6, 2020
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code KRD·November 6, 2020
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code KRD·November 6, 2020
NESTER PLATINUM EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·June 14, 2020
NESTER PLATINUM EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·February 19, 2020
2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·November 14, 2019
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023