95 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS
FDA 510(k)
FDA Class 2
·Orthopedic
LEONE SPA
FDA UDI
LEONE SPA·08033707010814·CALIBRA 1ST MOLAR BANDS n.UL 33
MAYO-HEGAR NEEDLE HOLDER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896021822·MAYO-HEGAR NEEDLE HOLDER SERRATED JAW
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450720905·
VISTA ENDOSCOPE,89 CM, 56CM , SCOUT BLUNT-TIPPED GUIDE- 106 CM, 86 CM, 53 CM, MODELS FG0027, FG0031, FG0029, FG 0028,
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INDIGO SYSTEM ASPIRATION CATHETER 5
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·November 21, 2016
INDIGO SYSTEM ASPIRATION CATHETER D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·February 12, 2019
INDIGO SYSTEM CATD ASPIRATION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·May 29, 2019
INDIGO SYSTEM CATD ASPIRATION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·January 17, 2020
INDIGO SYSTEM ASPIRATION CATHETER D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·December 7, 2018
INDIGO SYSTEM ASPIRATION CATHETER D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·January 29, 2021
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 24, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·September 30, 2014
CARELINK
FDA Adverse Event
Malfunction
·PLEXUS MANUFACTURING SDN. BHD.·Product code NVZ·June 16, 2011
INDIGO SYSTEM ASPIRATION CATHETER D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·December 10, 2020
PENUMBRA SYSTEM JETD REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·June 5, 2019
INDIGO SYSTEM CATD ASPIRATION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·January 25, 2019
INDIGO SYSTEM CATD ASPIRATION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·January 25, 2019
INDIGO SYSTEM CATD ASPIRATION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·July 28, 2020