23 results · 23ms · Sources: EU EUDAMED, 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