12 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL
FDA 510(k)
FDA Class 2
·General Hospital
SYNERGY HA COATED POROUS FEMORAL STEMS
FDA 510(k)
FDA Class 2
·Orthopedic
TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND
FDA 510(k)
FDA Class 1
·Dental
0009613348-2023-020996
FDA Adverse Event
Injury
·INSTITUT STRAUMANN AG·Product code DZE·March 3, 2023
OCTRODE LEAD KIT, 90CM LENGTH
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LGW·August 31, 2023
OCTRODE LEAD KIT, 90CM LENGTH
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LGW·June 26, 2025
WECKSTAT STAPLE REMOVER
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code MDM·March 20, 2013
ATTAIN OTW
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 16, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·March 26, 2008
Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·March 12, 2025
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014