11 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SnapHammer Hammertoe Correction System
FDA 510(k)
FDA Class 2
·Orthopedic
MYSPINE UNILATERAL LEFT GUIDE S01
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PQC·August 22, 2024
TERUMO SURGUARD 2 SAFETY NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
Fortilink Cages with TiPlus Technology
FDA 510(k)
FDA Class 2
·Orthopedic
TUBE, GASTROINTESTINAL (AND ACCESS)
FDA Adverse Event
Injury
·C.R. BARD, INC. (BASD)·Product code KNT·November 19, 2009
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008
TALENT CAPTIVA STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·August 12, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·July 17, 2013
Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.
FDA Enforcement
Class I
·Terminated·Hospira Inc.·May 7, 2014
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·December 13, 2017
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022