87 results · 23ms · Sources: EU EUDAMED, US FDA

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Expedium Spine System, VIPER and VIPER 2 Systems

FDA 510(k)
FDA Class 2 ·Orthopedic

OCTARAY Mapping Catheter

FDA UDI
Biosense Webster Inc·10846835021233·OCTA,PERSEID,2-2-2-2-2,F-CURVE

UniTip Catheter

FDA UDI
Unisensor AG·07640172972380·

RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

CLEANER ROTATIONAL THROMBECTOMY SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

OT VERIO PRO METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

CONCERTO

FDA Adverse Event
Malfunction ·WAVELIGHT GMBH·Product code LZS·June 16, 2011

COLLEAGUE CX VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·September 17, 2008

SHIRANUI EX

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·September 11, 2022

SHIRANUI EX

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·April 14, 2026

SHIRANUI EX

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·May 24, 2021

SHIRANUI EX

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·January 11, 2022

SHIRANUI EX

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·January 29, 2026

SHIRANUI HP

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·May 18, 2020

REPROCESSED CS DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER

FDA Adverse Event
Injury ·Product code NLH·October 29, 2025

SHIRANUI EX

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·October 22, 2024

SHIRANUI EX

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·August 12, 2020

PULSESELECT PULSED FIELD ABLATION (PFA) SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code QZI·September 2, 2025

SHIRANUI HP

FDA Adverse Event
Malfunction ·KANEKA CORPORATION·Product code LIT·April 24, 2019

SHIRANUI EX

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·December 6, 2024