18 results · 22ms · Sources: EU EUDAMED, US FDA

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Express SD Biliary Monorail Premounted Stent System

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

EXPRESS SD RENAL/BILIARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 22, 2025

EXPRESS SD RENAL/BILIARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 22, 2025

EXPRESS SD RENAL/BILIARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·September 3, 2025

EXPRESS SD RENAL/BILIARY

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 27, 2025

EXPRESS SD RENAL/BILIARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 12, 2025

EXPRESS SD RENAL/BILIARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·May 13, 2026

EXPRESS SD RENAL/BILIARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 11, 2025

CoRoent

FDA UDI
Nuvasive, Inc.·00887517575760·CoRoent Ant TLIF Ti, 16x12x40mm 4°

ECHO HIP SYSTEM INSTRUMENTATION

FDA UDI
Biomet Orthopedics, LLC·00880304463486·

Echo® Hip System Instrumentation

FDA UDI
Biomet Orthopedics, LLC·00887868474545·

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613088989·Obwegeser Periosteal Elev 11mm

TRANSEAR BONE CONDUCTION HEARING AID

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)

FDA 510(k)
FDA Class 2 ·Dental

ULTRACISION HARMONIC ACE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 14, 2011

PLM A+ SPANISH DEVIC

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·June 6, 2013

ONE TOUCH ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code NBW·September 9, 2008

C-FLEX MULTI-LENGTH URETERAL STENT SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FAD·January 24, 2020