25 results · 21ms · Sources: EU EUDAMED, 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