12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING
FDA 510(k)
FDA Class 2
·General Hospital
Medline Industries, Inc.
FDA UDI
MEDLINE INDUSTRIES, INC.·10888277903142·IV START KIT
EQUINOX CO2 LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRABECULAR METAL KNEE SYSTEM AUGMENTS
FDA 510(k)
FDA Class 2
·Orthopedic
AEQ REVERSED II GLENOID SPHERE D.42MM CENTER D 25MMBASEPLATE
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code PHX·October 2, 2024
X-SUIT NIR COVERED BILIARY METALLIC STENT
FDA Adverse Event
Malfunction
·MEDINOL LTD.·Product code FGE·December 27, 2017
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 3, 2014
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·May 31, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 27, 2011
BD VIPER¿ LT SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code OOI·August 14, 2023
AEQ REV II GLENOID BASEPLATE DIA 25MM LONG POST
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·January 7, 2025
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019