18 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BR-ABVS Viewer 1.0
FDA 510(k)
FDA Class 2
·Radiology
AGC TRADITION KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304240919·
AGXO
FDA UDI
Oticon A/S·05707131284358·H110V2 TI, BTE 13 WL 85 STG AGXO
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100233·LIEBERMAN ASPIRATING SPECULUM V-WIRE
Precontoured Rod Ø5.5 mm x75 mm Package
FDA UDI
XENCO MEDICAL LLC·B064XM21510751·
ELECSYS INSULIN CALCHECK 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ENCORE REVERSE SHOULDER PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
TriVerse Femoral Trial
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215098452·
BINAXNOW¿ COVID-19 ANTIGEN SELF TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·July 13, 2021
BINAXNOW COVID-19 AG SELF TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·July 20, 2021
BINAXNOW¿ COVID-19 ANTIGEN SELF TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 19, 2021
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·October 8, 2014
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·June 6, 2013
TOTAL ASR FEM IMP SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 30, 2011
BINAXNOW COVID-19 AG SELF TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·July 15, 2021
BINAXNOW¿ COVID-19 ANTIGEN SELF TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 5, 2021
BINAXNOW COVID-19 ANTIGEN SELF TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·February 12, 2022
EZ-IO INTRAOSSEOUS INFUSION SYSTEM NEEDLE SET
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FMI·August 24, 2020