11 results · 20ms · Sources: EU EUDAMED, US FDA

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CRYOTHERM

FDA 510(k)
FDA Class 2 ·Physical Medicine

INNOFLUOR PRIMIDONE

FDA 510(k)
FDA Class 1 ·Microbiology

NEMECTRODYN MODEL 2 & ENDOVAC 2

FDA 510(k)
FDA Class 2 ·Neurology

STARDRIVE SCREWDRIVER SHAFT T8 CYLINDRICAL WITH GROOVE

FDA Adverse Event
Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HXX·October 23, 2019

SECURA DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 10, 2014

DEXTRUS 4136

FDA Adverse Event
Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·October 5, 2010

MINICAP TRANSFER SET

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·December 10, 2012

SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB

FDA Recall
Open, Classified ·LumiraDx·Product code KXG·April 25, 2023

LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control

FDA Recall
Terminated ·LumiraDx·Product code QKO·June 24, 2022

LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users with assurance that the device is performing within specification

FDA Recall
Terminated ·LumiraDx·Product code QKP·September 23, 2022

LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip

FDA Recall
Terminated ·LumiraDx·Product code QKO·June 24, 2022