BEUDAMED
    25 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    Product 68 consists of all product under product code: JDI and same usage: Item no: 787101360 VERSYS CEM/REV/CALCAR 13X 787101361 VERSYS CEM/REV/CALCAR 13X 787101362 VERSYS CEM/REV/CALCAR 13X 787101363 VERSYS CEM/REV/CALCAR 13X 787101560 VERSYS CEM/REV/CALCAR 15X 787101561 VERSYS CEM/REV/CALCAR 15X 787101562 VERSYS CEM/REV/CALCAR 15X 787101563 VERSYS CEM/REV/CALCAR 15X 787101760 VERSYS CEM/REV/CALCAR 17X 787101761 VERSYS CEM/REV/CALCAR 17X 787101761 VERSYS CEM/REV/CALCAR 17X For use in total or hemi hip arthroplasty

    FDA Enforcement
    Class II ·Terminated·Zimmer Manufacturing B.V.·March 23, 2016

    Product 19 consists of all product code: JDI and same usage: Item no: 765301101 CEM FEM ST 11X120 NOCOAT 765301201 CEM FEM ST 12X125 NOCOAT 765301301 CEM FEM ST 13X130 NOCOAT 765301401 CEM FEM ST 14X135 NOCOAT 765301501 CEM FEM ST 15X140 NOCOAT 765301601 CEM FEM ST 16X145 NOCOAT 763301300 CEM FEM ST FX 13 X 130 763301600 CEM FEM ST FX 16 X 145 For use in total or hemi hip arthroplasty

    FDA Enforcement
    Class II ·Terminated·Zimmer Manufacturing B.V.·March 23, 2016

    12/14 UNIPOLAR FEMORAL HE VERSYS CEM LD/FX SZ 11X12 VERSYS CEM LD/FX SZ 12X12 VERSYS CEM LD/FX SZ 14X13 VERSYS CEM LD/FX SZ 16X14 VERSYS CEM LD/FX ST 18X15 VERSYS PRESS FIT LD/FX ST VERSYS PRESS FIT LD/FX SZ VERSYS ADVOCATE CEMENTED VERSYS ADVOCATE V-LIGN CE VERSYS CEMENTED FEM STEM VERSYS CT FEM STEM 11X120 VERSYS CT FEM STEM 12X125 VERSYS CT FEM STEM 13X130 VERSYS CT FEM STEM 14X135 VERSYS CT FEM STEM 15X140 VERSYS CT FEM STEM 16X145 VERSYS CT FEM STEM 17X150 VERSYS CEM/REV/CALCAR 13X VERSYS CEM/REV/CALCAR 15X VERSYS CEM/REV/CALCAR 17X VERSYS CEM/REV/CALCAR 19X

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·February 26, 2014

    TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC: THUNDERBEAT 5 mm, 35 em, Inline Grip TB-0520IC: THUNDERBEAT 5 mm, 20 em, In line Grip TB-051 OIC: THUNDERBEAT 5 mm, I 0 em, In line Grip TB-545FC: THUNDERBEAT 5 mm, 45 em, Front Actuated Grip TB-0535FC: THUNDERBEAT 5 mm, 35 em, Front Actuated Grip The Olympus Thunderbeat Surgical Tissue Management System ("Thunderbeat") is intended to be used for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.

    FDA Enforcement
    Class II ·Terminated·Olympus America Inc.·December 11, 2013

    Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·February 26, 2014

    Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·August 25, 2021

    AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators. The device is model FC03XX series. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators.

    FDA Enforcement
    Class II ·Terminated·Encision, Inc.·July 18, 2012

    Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator. Used in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·March 20, 2013

    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.

    FDA Enforcement
    Class II ·Ongoing·DEPUY (IRELAND)·May 6, 2026

    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207.

    FDA Enforcement
    Class II ·Ongoing·DEPUY (IRELAND)·May 6, 2026

    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.

    FDA Enforcement
    Class II ·Ongoing·DEPUY (IRELAND)·May 6, 2026

    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.

    FDA Enforcement
    Class II ·Ongoing·DEPUY (IRELAND)·May 6, 2026

    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.

    FDA Enforcement
    Class II ·Ongoing·DEPUY (IRELAND)·May 6, 2026

    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.

    FDA Enforcement
    Class II ·Ongoing·DEPUY (IRELAND)·May 6, 2026

    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.

    FDA Enforcement
    Class II ·Ongoing·DEPUY (IRELAND)·May 6, 2026

    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.

    FDA Enforcement
    Class II ·Ongoing·DEPUY (IRELAND)·May 6, 2026

    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.

    FDA Enforcement
    Class II ·Ongoing·DEPUY (IRELAND)·May 6, 2026

    SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models specific intended uses are to control difficult bleeds in the inguinal area and to immobilize a pelvic fracture.

    FDA Enforcement
    Class II ·Terminated·Sam Medical Products·November 5, 2014

    SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09

    FDA Enforcement
    Class II ·Terminated·Sam Medical Products·March 23, 2022

    SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood

    FDA Enforcement
    Class II ·Terminated·BBI SOLUTIONS OEM LTD·November 2, 2016