28 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL
FDA 510(k)
FDA Class 2
·Microbiology
Sklar®
FDA UDI
SKLAR CORPORATION·10649111084294·LISTER BAND SCISS 7.25"
Drill bit
FDA UDI
Jeil Medical Corporation·08809282815683·
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213015555·microSelectron Transfer Tube for 4F Flexibles (1)
Summa Orthopaedics System Surgical Instrument
FDA UDI
Jeil Medical Corporation·08806390865265·
TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE
FDA 510(k)
FDA Class 2
·Orthopedic
GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT BIFOCAL CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·April 8, 2018
Trabecular Metal®
FDA UDI
Zimmer, Inc.·00889024130180·
Widex
FDA UDI
Widex A/S·05706069620412·Widex UNIQUE U-FA 110 DEMO (Winter silver ) Tel...
Trabecular Metal®
FDA UDI
Zimmer, Inc.·00889024130166·
Widex
FDA UDI
Widex A/S·05706069657616·Widex UNIQUE U-FP 110 DEMO (Winter silver ) Tel...
Trabecular Metal®
FDA UDI
Zimmer, Inc.·00889024130197·
Widex
FDA UDI
Widex A/S·05706069657951·Widex BEYOND B-F2 110 DEMO (Winter silver ) Tel...
Widex
FDA UDI
Widex A/S·05706069620597·Widex UNIQUE U-FS 110 DEMO (Winter silver ) Tel...
Trabecular Metal®
FDA UDI
Zimmer, Inc.·00889024130173·
BD POSIFLUSH NORMAL SALINE SYRINGE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code NGT·August 5, 2021
10 ML BD POSIFLUSH NORMAL SALINE SYRINGE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code NGT·September 20, 2021
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MHY·May 14, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 23, 2014