7 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BRASS NICK IMPRES TRAY/AMALGAM CAR/SYRIN CART/ARTI
FDA 510(k)
FDA Class 2
·Dental
SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
SECHRIST IV-100B SAVI SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
UNKNOWN DEPUY FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWY·January 23, 2013
ATTAIN OTW
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 14, 2010
PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 58MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·July 10, 2014
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025