16 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANNE Limb
FDA 510(k)
FDA Class 2
·Cardiovascular
CoRoent
FDA UDI
Nuvasive, Inc.·00887517631077·CoRoent Ant TLIF Ti, 14x10x30mm 15°
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017972·K-Wire, Single Ended, Trocar Point, Diameter Si...
TriplePlay
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377021770·FM4 - Embla-N7000 Bedside Unit
VITREA2 VERSION 3.5
FDA 510(k)
FDA Class 2
·Radiology
CAYA CONTOURED DIAPHRAGM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 20, 2023
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 24, 2008
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011
HEARTSTART XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 8, 2013
BD CONVENTIONAL NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·February 26, 2025
BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019