27 results · 37ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL

FDA 510(k)
FDA Class 2 ·Dental

ORTHOFIX

FDA UDI
ORTHOFIX SRL·18059015374360·STANDARD LOCKING SCREW L35.0MM D4.0MM

Thermoflect

FDA UDI
Encompass Group, L.L.C.·30612899514356·THERMOFLECT JACKET, M, 25EA ...

Fuji Cervical Plate System

FDA UDI
Altus Spine, LLC·B41711403501·50mm Level 3 Cervical Plate System - Fuji

ORTHOFIX

FDA UDI
ORTHOFIX SRL·18059015373868·STANDARD LOCKING SCREW L35.0MM D4.0MM STERILE

Mariner Outrigger

FDA UDI
Seaspine Orthopedics Corporation·10889981161552·Z-Rod, Dia. 6.0mm, Co-Cr, 350mm

Kalitec Universal Instruments

FDA UDI
Kalitec Direct LLC·B07301K1103500·Tray, Base, 3.5", Arcamed

RANDOX AMPHETAMINE CLASS ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

HOVEROUND TEKNIQUE GT POWER WHEELCHAIR, MODEL# TEKNIQUE GT

FDA 510(k)
FDA Class 2 ·Physical Medicine

T:SLIM X2 INSULIN PUMP

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code LZG·March 15, 2018

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 5, 2022

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 29, 2023

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 29, 2022

UNSPECIFIED BD ECLIPSE¿ NEEDLE

FDA Adverse Event
Injury ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·February 14, 2017

25 G X 1 IN. BD ECLIPSE¿ NEEDLE

FDA Adverse Event
Injury ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·February 1, 2017

BREEZE2

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·December 18, 2009

GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/10 MM RIGHT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 22, 2017

TENDRIL SDX

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code DTB·January 13, 2014

PROLENE POLYPROPYLENE MESH

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·May 31, 2013

CENTRA BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·June 16, 2011