23 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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