10 results
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68ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Yadu Medical Face Mask (Level 1)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NA
FDA UDI
Synthes GmbH·10886982152626·3.5MM CONICAL SCREW SLF-TPNG FULLY THREADED 90MM
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523101245·R CR Cemented Femoral Component Sz 3N
KOWA VX-20
FDA 510(k)
FDA Class 2
·Ophthalmic
SIMPLICITY EURO QD INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
SD/PD MEDIUM CURVED
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·October 30, 2014
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·August 15, 2011
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 9, 2013
EQUINOXE REVERSE SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·April 16, 2024
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
FDA Enforcement
Class II
·Ongoing·Abbott Medical·January 1, 2025