BEUDAMED
    22 results · 23ms · Sources: EU EUDAMED, US FDA

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    INTEGRA(TM) CUSA NXT(TM) BONE TIPS

    FDA 510(k)
    FDA Unclassified ·Unknown

    MAXCUT CARBIDE BUR (10/pk) FGSU # 701

    FDA UDI
    SCOTT'S DENTAL SUPPLY L.L.C.·D77811117411·MAXCUT CARBIDE BUR (10/pk) Shape: Round; Size: ...

    DIATRON PICTUS 400

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CRIT-LINE MONITOR III TQA (CLM TQA)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    JRNY BCS PAT RESRF RD 35 MM STD

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·August 30, 2017

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 8, 2025

    PLMA DVC V11.51 1 N

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD·Product code FRN·May 7, 2013

    ENDOPATH** XCEL* DILATING TIP TROCAR

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·June 2, 2011

    OPTEASE VENA CAVA FILTER

    FDA Adverse Event
    Injury ·CORDIS EUROPA, N.V.·Product code DTK·August 12, 2008

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·June 18, 2010

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·June 18, 2010

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·June 18, 2010

    JOURNEY POLY TIBIAL INSERT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·June 12, 2017

    EVOLUT R TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·December 19, 2019

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·December 19, 2019

    COREVALVE TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·December 19, 2019

    PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·October 15, 2025

    StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.

    FDA Enforcement
    Class II ·Terminated·Abbott Vascular·February 22, 2017

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018