35 results · 24ms · Sources: EU EUDAMED, US FDA

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SmoothCool HR System

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

TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH

FDA 510(k)
FDA Class 2 ·Cardiovascular

SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON A)SOFT (HYDROPHILIC) CONTACT LENS

FDA 510(k)
FDA Class 2 ·Ophthalmic

GLP TRACK END

FDA Adverse Event
Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·May 18, 2026

DEFIBRILLATOR/PACEMAKER

FDA Adverse Event
Death ·ZOLL MEDICAL CORP·Product code LDD·October 29, 2008

ULTRAFLEX¿ TRACHEOBRONCHIAL

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - GALWAY·Product code JCT·August 16, 2011

URETEX SUP URETHRAL SUPPORT SYSTEM

FDA Adverse Event
Injury ·SOFRADIM PRODUCTION·Product code OTN·April 9, 2013

ENSITE CLASSIC SYSTEM

FDA Adverse Event
Injury ·ST. JUDE MEDICAL·Product code DQK·February 9, 2010

SNAPLOC WIRE GUIDE LOCKING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·December 18, 2024

SNAPLOC WIRE GUIDE LOCKING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·December 16, 2024

SNAPLOC WIRE GUIDE LOCKING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·May 20, 2024

SNAPLOC WIRE GUIDE LOCKING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·June 10, 2024

GLP CENTRIFUGE MODULE

FDA Adverse Event
Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·July 10, 2025

SNAPLOC WIRE GUIDE LOCKING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·December 13, 2024

GLP CENTRIFUGE MODULE

FDA Adverse Event
Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·December 27, 2024

SNAPLOC WIRE GUIDE LOCKING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·November 11, 2024

SNAPLOC WIRE GUIDE LOCKING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·November 11, 2024

GLP CENTRIFUGE MODULE

FDA Adverse Event
Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·April 28, 2025

GLP ALIQUOT MODULE

FDA Adverse Event
Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·August 1, 2025

GLP TRACK END

FDA Adverse Event
Malfunction ·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·April 1, 2026