25 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
Integrity-SI Fusion System
FDA UDI
Lincotek Medical LLC·B57112521010081D0·10 x 80 mm SI Implant with HA Coating
Ocata Anterior Cervical System
FDA UDI
Kalitec Direct LLC·B07308K0100010·Caddie, Plates
TiWAVE C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07320K0100110·Handle, Universal Slim with Depth Stops
MATIRA ANTERIOR CERVICAL SYSTEM
FDA UDI
Kalitec Direct LLC·B07307K0100010·Caddie, Common Plates and Screws
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K0100010·Tamp, Modular Tip, InTess C
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 11, 2025
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100210·SNII Awl Tap, 5.50mm
Matira
FDA UDI
Kalitec Direct LLC·B07307K0100210·Assembly, Caddie, Plates and Screws, Hinged
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100180·SNII Tap, 6.50mm
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0100210·Caddie Lid, Rods, 5.5mm
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 17, 2025
MANUAL AND REMOTE CONTROLLED APPLICATOR SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810
FDA 510(k)
FDA Class 2
·Cardiovascular
SYRINGE 1ML LS SP120
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·August 19, 2021
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 12, 2025
SYRINGE 1ML LS SP120
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·August 19, 2021
SYRINGE 1ML LS SP120
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·August 26, 2021
RELIANCE OSTEOTOME CURVED
FDA Adverse Event
Malfunction
·STRYKER SPINE-FRANCE·Product code LXH·October 10, 2013
AXSYM DIGOXIN III
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·May 11, 2007