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

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    THE Graft Collagen

    FDA 510(k)
    FDA Class 2 ·Dental

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517630353·CoRoent Ant TLIF Ti, 13x10x30mm 15°

    HHM

    FDA UDI
    Sbo Hearing A/S·05714464029792·HHM F400 MINIRITE T C044

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780382829·Integra® Jarit® Ruskin-Liston Bone Cutting Forc...

    Cyto-Chex BCT

    FDA UDI
    STRECK, INC.·20844509002202·A direct-draw blood collection tube for the pre...

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120700·Steinmann Pin 3.5x230mm (9/64 x 9")

    NPseal

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

    LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    3ML LL WITH CO-PACKED NEEDLE 26GX3/8'

    FDA Adverse Event
    Malfunction ·EXELINT INTERNATIONAL, CO.·Product code FMF·August 15, 2025

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    Malfunction ·INVACARE REHABILITATION EQUIP·Product code FSA·November 6, 2014

    BECKMAN COULTER¿ COULTER® LH 750 HEMATOLOGY

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·September 1, 2011

    SYNCHROMED

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code LKK·July 16, 2013

    R-LISTON CUTT FCPS 7-1/4 STR

    FDA Adverse Event
    Injury ·INTEGRA YORK, PA INC.·Product code HTZ·July 11, 2018

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.

    FDA Enforcement
    Class II ·Ongoing·Staar Surgical Company·December 13, 2023

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021

    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