23 results · 28ms · Sources: EU EUDAMED, US FDA

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Disposable Surgical Gowns

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

TISSUELINK BIPOLAR FLOATING BALL DEVICE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING

FDA 510(k)
FDA Class 2 ·Cardiovascular

NAMIC KIT SYRINGE 2025-32-200662043

FDA Adverse Event
Malfunction ·MEDLINE INDUSTRIES, LP - NAMIC·Product code OEZ·April 17, 2025

M SERIES

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·October 8, 2008

UNICEL DCX 600I SYNCHRON ACCESS CLINICAL SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code MMI·August 5, 2011

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 2, 2013

UNKNOWN EMPRINT GENERATOR

FDA Adverse Event
Injury ·COVIDIEN LP - SUPERDIMENSION INC·Product code NEY·December 17, 2025

UNKNOWN EMPRINT GENERATOR

FDA Adverse Event
Injury ·COVIDIEN MEDICAL PRODUCTS·Product code NEY·December 17, 2025

UNKNOWN ENDO GIA SULU

FDA Adverse Event
Injury ·COVIDIEN SURGICAL·Product code GDW·October 16, 2025

SELECTSECURE MRI SURESCAN

FDA Adverse Event
Malfunction ·MEDTRONIC, INC.·Product code NVN·September 3, 2025

REZUM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·August 12, 2025

GREENLIGHT HPS LASER SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code GEX·August 12, 2025

SELECTSECURE MRI SURESCAN

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code NVN·September 3, 2025

ABRE VENOUS SELF-EXPANDING STENT SYSTEM

FDA Adverse Event
Injury ·COVIDIEN·Product code QAN·April 3, 2026

ABRE VENOUS SELF-EXPANDING STENT SYSTEM

FDA Adverse Event
Death ·COVIDIEN·Product code QAN·April 3, 2026

ABRE VENOUS SELF-EXPANDING STENT SYSTEM

FDA Adverse Event
Injury ·COVIDIEN·Product code QAN·April 3, 2026

ARCHITECT ESTRADIOL REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CHP·May 1, 2025

ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·February 18, 2026

ALINITY I PROCESSING MODULE

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JJE·July 2, 2025