11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FiberTak DR
FDA 510(k)
FDA Class 2
·Orthopedic
OsteoMed
FDA UDI
OSTEOMED LLC·00845694036085·Tri-Lobe Driver, Solid Core, Short, 3.0/4.0mm H...
B-P TOTAL HIP SYSTEM
FDA UDI
ENDOTEC, INC.·00814193024145·B-P MODULAR EXTENSION W/ULTRACOAT - 19 MM X 75 MM
EVERCROSS 0.035 OTW PTA DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L
FDA 510(k)
FDA Class 2
·Cardiovascular
ARCHITECT C4000 ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JJE·May 5, 2017
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2013
WECK HEMOCLIP
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FZP·April 27, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008
BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·June 12, 2023
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020