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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TSRH SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890107200·Zirlux 30 Degree Multi-Unit Abutment 4.5 mmH co...
ZIMMER MEDIZINSYSTEME GMBH
FDA registration
ZIMMER MEDIZINSYSTEME GMBH·15 products·🇩🇪 Germany
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450207345·
InSePtion MIS Fixation System
FDA UDI
Kalitec Direct LLC·B07314K0100200·Caddie, Implant
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100200·SNII Screwdriver, Poly Std Assembly
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0100200·Caddie Lid, All Sizes
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0100200·Caddie, Rods, 5.5mm Assembly
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345027244·Inserter, 11-16MM, Lumbar Straight
INSET
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 12, 2025
AUTOSOFT XC
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 29, 2025
AUTOSOFT XC
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 29, 2025
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 18, 2025
SYNTHES SACRAL BAR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS REUSABLE CONNECTOR CABLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
JDEVOLUTION PLUS
FDA Adverse Event
Injury
·J DENTAL CARE SRL·Product code DZE·August 6, 2025
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 9, 2025
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·September 9, 2010
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·March 19, 2013
NC MERLIN PTCA CATHETER (OTW)
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·March 8, 2011