BEUDAMED
    24 results · 24ms · Sources: EU EUDAMED, US FDA

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    Patient Monitor (RespArray)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517578860·CoRoent Ant TLIF Ti, 14x10x32mm 0°

    ESR-Vacuum tubes

    FDA UDI
    STRECK, INC.·00844509000068·2.0ml tri-sodium citrate blood collection tubes...

    OMNI Knee

    FDA UDI
    Omni Life Science, Inc.·00841690101949·All Poly 3 Peg Patella 32 mm x 10 mm

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690199328·Patella Trial 32mm x 10mm

    TriplePlay

    FDA UDI
    DYMEDIX DIAGNOSTICS, INC.·00817377022739·iFM - Universal

    Meridian

    FDA UDI
    Seaspine Orthopedics Corporation·10889981215828·No-Profile Interbody, 3-Hole Faceplate 20mm

    Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SINON POWER WHEELCHAIR, SN-P401

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·November 25, 2020

    ACCU-CHEK ULTRAFLEX INFUSION SET

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS·Product code FPA·June 15, 2009

    RELION CONFIRM BLOOD GLUCOSE TEST SYSTEM

    FDA Adverse Event
    Injury ·ARKRAY, INC.·Product code NBW·January 23, 2018

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 29, 2014

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·September 9, 2011

    LCP-SCR Ø4 F/SYNFIX-LR L25 TAN

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code MAX·July 22, 2013

    BD CONVENTIONAL NEEDLES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·October 30, 2024

    BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 178575 178576 178577 178578 178579 178580 178730 178731 178732 178733 178734 178735 178354S 178754 178755 178756 178757 178758 178759 Product Usage: 1) Correction of revision of unsuccessful osteotomy, arthrodesis or previous joint replacement 2) Tumor resections 3) Revision of previously failed total joint arthroplasty 4) Trauma The ComPreSs Distal Femoral Replacement System is intended for uncemented use.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020