23 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KAVO QUATTROCARE
FDA 510(k)
FDA Class 1
·Dental
Zirlux
FDA UDI
HENRY SCHEIN, INC.·00304040056097·Zirlux Multi Anterior A1,98.5X12
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776201425·Bimanual Irr Unit g Cann Tip
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345024038·Paddle Shaver, 8mm
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0103080·Shaver, Closed, 8mm
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 9, 2026
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132080·Trial, TLIF, 27L OB CRV 7Deg, 8mm
Cosmolock
FDA UDI
Kalitec Direct LLC·B07310K0123000·Recovery Tube, MIS
OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MULTISTIM
FDA 510(k)
FDA Class 2
·Anesthesiology
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 12, 2025
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 17, 2025
SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·November 12, 2019
D131 KIDS INFANT ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTM·May 20, 2026
ARTICULEZE M HEAD 36MM +12
FDA Adverse Event
Injury
·8010379 DEPUY INTL., LTD.·Product code JDI·March 20, 2013
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 15, 2014
PRSVN ALLPOLY TIB LMRL S2 7MM
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.·Product code HRY·February 11, 2008
D131 KIDS INFANT ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL.·Product code DTM·September 26, 2024
D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTM·June 18, 2019
D131 DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE
FDA Adverse Event
SORIN GROUP ITALIA·Product code DTM·February 3, 2016