29 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SAFI-GEL DAILY DISPOSABLE (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, SAFI-GEL DAILY DISPOSABLE TORIC ( METHAFILCON
FDA 510(k)
FDA Class 2
·Ophthalmic
LEONE SPA
FDA UDI
LEONE SPA·08033707065708·INTRAORAL ELASTICS 4,5 oz 1/4" red
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450214206·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450213650·
Medline
FDA UDI
MEDLINE INDUSTRIES, INC.·10884389028018·FENESTRATED DRAPE, 24 X 36
ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Immunology
KARL STORZ HYSTEROMAT II
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MEDACTA KNEE IMPLANTS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 28, 2016
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·March 9, 2023
GEMSTAR SPLT SET Y-EXT W/ BACKCHK 282CM
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·April 15, 2013
UNK
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·February 23, 2011
HIRES 90K
FDA Adverse Event
Injury
·ADVANCED BIONICS LLC·Product code MCM·May 10, 2011
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
Malfunction
·UNKNOWN·Product code IKX·May 2, 2013
AFX SYSTEM
FDA Adverse Event
Injury
·ENDOLOGIX, INC.·Product code MIH·September 15, 2014
COBAS® SARS-COV-2 & INFLUENZA A/B
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QLT·May 26, 2022
COBAS® SARS-COV-2 & INFLUENZA A/B
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QLT·May 19, 2022
COBAS TAQSCREEN MPX TEST V2
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·October 13, 2021
COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QJR·July 14, 2021
COBAS® SARS-COV-2 & INFLUENZA A/B
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QLT·May 26, 2022
COBAS® SARS-COV-2 ¿ 480T
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QJR·August 18, 2022