11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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