56 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Illuminated Mediastinal Access Port
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486003104·MCK PEG DRILL (PATELLAR/TIBIAL)
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221044600·Unitek(TM) Molar Band General Purpose Narrow Re...
Denovo general purpose dental molar band
FDA UDI
Denovo Dental, Inc.·00810059290259·Denovo general purpose dental molar band - Maxi...
CLEANSE S+ ULTRASONIC SCALER
FDA 510(k)
FDA Class 2
·Dental
NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS
FDA 510(k)
FDA Class 2
·Dental
T:SLIM G5 SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·April 7, 2023
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 9, 2022
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 12, 2024
FLOGARD
FDA Adverse Event
Malfunction
·SHARP CORPORATION OSAKA JAPAN·Product code FRN·June 10, 2013
PARADIGM REAL -TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 19, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·July 13, 2011
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·September 3, 2025
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·September 3, 2025
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·September 3, 2025
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·September 3, 2025
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE GMBH·Product code NBW·April 27, 2020
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE GMBH·Product code NBW·April 27, 2020
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·July 18, 2025
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·September 3, 2025