BEUDAMED
    14 results · 28ms · Sources: EU EUDAMED, US FDA

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    JECT-AID

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Endodontic Hand Instruments

    FDA UDI
    TULSA DENTAL PRODUCTS LLC·D71668530311·HEDSTROM READY STEEL 31MM 030

    ReadySteal Hedstrom File

    FDA UDI
    TULSA DENTAL PRODUCTS LLC·D71668530312·Ready Steal Hedstrom File Size 6853031 Length

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707031116·WEB 1ST MOL BANDS W/G8325-03 UL 31

    Legacy™ Straight Contoured Abutment

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307111948·

    Pagoda

    FDA UDI
    Ortho Development Corporation·00822409029532·Diameter 8.5 mm x 30 mm Monoaxial Screw

    Custom Legacy Titanium Abutment

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307116875·

    Legacy™ Custom Titanium Abutment

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307133728·

    RANGE/DENALI/MESA Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EXTENDSURE HBFASC CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    OT VERIO TEST STRIPS

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2014

    OMNILINK ELITE PERIPHERAL STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIO·November 30, 2012

    STRETCHER

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIV·Product code FPO·September 21, 2010

    Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30") Appx 3.2 ml, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Purple Cap, Bag Hanger, REF: 011-CH3185; 46 cm (18") Appx 7.4 ml, Trifuse Add-On Set w/2 Spiros w/Purple Caps, Bag Spike, 3 Clamps (Blue, 2 Red), Dry Spike Adapter, REF: 011-CH3266; 76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Purple Cap, 20 Drop In-Line Drip Chamber, Bag Hanger, REF: 011-CH3446; 61 cm (24") Appx 8.2 ml, Bifuse Add-On Set w/Bag Spike, Spiros w/Purple Cap, 3 Clamps (1 Blue, 2 White), Check Valve, Dry Spike Adapter, REF: 011-CH3729; 25 UNITS of Spiros CLOSED MALE LUER, REF: 011-H2457; Appx 1.0 ml, Adattatore per Pompa con Spiros, REF: 011-H2629; 179 cm (70") Appx 11.5 ml, PUR Ambr. Deflussore con Spiros, Camera, BCV, Y-Clave e LL Gir., REF: 011-H2776; 180 cm (71IN)APPX 11.5ml,PUR AMBR,Spiros,CAMERA,REG.FLUSSO,BCV,Y-Clave, REF: 011-H2864-HSR; 181cm(71 IN)APPX11.6ml,PUR DEFLUSSORE,Spiros,20 DROP IN LINE,BCV,Clave, REF: 011-H2904; 38 cm (15 IN) APPX 2.9 ml, TRIFUSE EXT SET, 3 MicroClave, Spiros, PURPLE CAP, REF: 011-H3449; 42cm(16.5 IN)APPX 2.6ml,PUR TRANSFER SET,Clave ADDITIVE PORT,BCV,Spiros, REF: 011-H3597; 41cm(16 IN)APPX 2.9ml,PUR SET PERFORATORE,Clave,VALVOLA,Spiros, REF: 011-H3628; 41cm(16 IN)APPX 3.1ml,SET AMBRATO,PERFORATORE,Clave,VALVOLA,Spiros, REF: 011-H3629; 42cm(16.5 IN)APPX 5.6ml,SET,PERFORATORE,Clave,FILTRO,VALVOLA,Spiros, REF: 011-H3630; 109 cm(43 IN) APPX 7.2 ml,KIT,EXT SET W/Spiros,STOPCOCK,5 Clave,4-GANG STOPCOCK, REF: 011-MC330632; 2 Ext Sets w/5-Gang Stopcock, 9 Clave, Spiros, Stopcock, REF: 011-MC33242; Kit for multiple transfers, REF: 011-N1000; Kit per il riempimento pompe elastomeriche con SPIROS / Kit for elastomeric pump priming with SPIROS, REF: 011-N1000-P2; APPX 2.3ml, ZYTO-VERBINDUNGSLEITUNG (ZYTO-CONNECTING LINE), REF: 011-N1664SP; Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros, REF: 034-H2629; Spinning Spiros Closed Male Luer, Red Cap (No Flange), REF: CH2000S-NR; 15" (38 cm) Appx 5.2 ml, Bifuse Add-On Set w/Bag Spike, Spiros, 3 Clamps (Blue, 2 White), Dry Spike Adapter, REF: CH3187; 14" (36 cm) Appx 8.0 ml, Quinfuse Add-On Set w/4 Spiros, Bag Spike, 5 Clamps (Blue, 4 Red), Dry Spike Adapter, REF: CH3225; 20" (51 cm) Appx 9.5 ml, Quadfuse Add-On Set w/3 Spiros, Bag Spike, 4 Clamps (Blue, 3 Red), Dry Spike Adapter, REF: CH3226; 16" (41 cm) Appx 6.3 ml, Trifuse Add-On Set w/2 Spiros, Bag Spike, 3 Clamps (Blue, 2 Red), Dry Spike Adapter, REF: CH3227; 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 Micron Filter, Spiros, REF: CH3235; 28" (71 cm) Appx 5.1 ml, Add On Set w/Clave Spike, Spiros, Clamp, REF: CH3354; 16cm(6 IN)APPX 2.4ml,SET,MicroClave Clear,STOPCOCK,DROP-IN ADD-ON,Spiros, REF CH3411: APPX 1.9 ml,13 cm (5 IN),BAG SPIKE,Spiros,ACCESS DEVICE w/Clave, REF: CH3502; 60 (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Low Protein Binding Filter, Spiros w/Red Cap, Clamp, REF: CH3603; Spinning Spiros Closed Male Luer, REF: K7040-001; APPX 0.76ml, 4-WAY STOPCOCK w/2 Clave, VIAL ADAPTER, 3 Spiros, REF: K7052-001; ZYTOmed Verab.-Set Onko II lichtschutz, REF: SN1205AG; ZYTOmed - Verabreichungs-Set Onko III lichtgesch¿tzt, REF: SN1206A; Conector macho cerrado Spinning Spiros, tapon purpura, REF: 034-CH2000S-PC

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·December 30, 2020