22 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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SNAP WOUND CARE SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PINNACLE®
FDA UDI
B. BRAUN MEDICAL INC.·04046964200229·PINNACLE® 6-Lead Vented Transfer Set
Truline
FDA UDI
Arbill Industries, Inc.·00850052602246·Made in Malaysia. Blue disposable Nitrile. Siz...
Truline
FDA UDI
Arbill Industries, Inc.·10850052602007·
TRANSLUX ENERGY
FDA 510(k)
FDA Class 2
·Dental
VIPI BLOCK
FDA 510(k)
FDA Class 2
·Dental
SYSTEM 5 SAGITTAL SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code KIJ·May 14, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 23, 2014
CONTOUR TEST STRIPS
FDA Adverse Event
Injury
·BAYER HEALTHCARE, LLC·Product code NBW·May 27, 2011
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·November 9, 2023
GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MAF·July 27, 2022
XIENCE PROS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR·Product code NIQ·March 26, 2024
PERCLOSE PROGLIDE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·June 24, 2024
PERCLOSE PROGLIDE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·June 24, 2024
PERCLOSE PROGLIDE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·June 24, 2024
PERCLOSE PROGLIDE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·June 24, 2024
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·March 15, 2023
DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.
FDA Enforcement
Class II
·Terminated·Medrad Inc·February 27, 2013
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023