BEUDAMED
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    Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012

    FDA Enforcement
    Class II ·Ongoing·Aomori Olympus Co., Ltd.·September 13, 2023

    Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202 Lithium-ion Battery Cable, JHI-204 Extensions Cable, JHI-201 Pedestal Cable

    FDA Enforcement
    Class II ·Terminated·Jarvik Heart Inc·December 26, 2018

    Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter. The Arrow Berman(TM) Angiographic Catheter is indicated for use in right heart catheterization for cardiac angiography, and measurement of the right heart and pulmonary artery pressures. It can be sued to inject radiopaque media and measure pressures in any chamber or vessel that can be entered from the right heart. The Arrow Berman(TM) Angiographic Catheter is also indicated for use in Balloon Occlusion Femoral Angiography (BOFA) of the ipsilateral leg for adult patients. The Arrow Reverse Berman(TM) Angiographic Catheter is indicated for balloon occlusion pulmonary angiography.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·April 10, 2013

    ARTHROSCOPY SUP JOI PACK Procedure tray Catalog Number: BPAS17C

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·July 17, 2024

    Product 64 consists of all product under product code: JDI and same usage: Item no: 902605101 UNIPOLAR ENDO FEM HEAD 51MM For use in hemi hip arthroplasty

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

    Product 72 consists of all product code: JDI and same usage: Item no: 805002202 ZIMTRON HEAD 12/14 0X22 MM For use in total or hemi hip arthroplasty

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

    Product 28 consists of all product under product code: JDI and same usage: Item no: 32902605000 FEMORAL HD 28MM MEDIUM 32902604000 FEMORAL HD 28MM SHORT 32902604035 FEMORAL HD 28MM SHT+ 3.5M For use in total or hemi hip arthroplasty

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

    Product 39 consists of all product under product code: JDI and same usage: Item no: 32902605800 ION IMPLANTED FEM 22MM LO 32902604900 ION IMPLANTED FEM 26MM ME 32902603900 ION IMPLANTED FEM 26MM SH For use in total or hemi hip arthroplasty

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

    Product 69 consists of all product under product code: JDI and same usage: Item no: 785301701 VERSYS CEMENTED FEM STEM 785301521 VERSYS CEMENTED FEM STEM 15X140MM X-OFF 785301601 VERSYS CEMENTED FEM STEM 16X145MM For use in total or hemi hip arthroplasty

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

    Product 15 consists of all product code JDI , and same usage: Item no: 805002802 ASTEL FEM HEAD +0X28MM DI 805002805 ASTEL FEM HEAD +10.5X28MM 805002803 ASTEL FEM HEAD +3.5X28MM 805002804 ASTEL FEM HEAD +7X28MM DI 805002801 ASTEL FEM HEAD -3.5X28MM Usage: For use in total or hemi hip arthroplasty

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

    Product 33 consists of all product under product code: JDI and same usage: Item no: 662406515 HGP II ACETABULAR CUP BON 662406520 HGP II ACETABULAR CUP BON 662406525 HGP II ACETABULAR CUP BON 662406530 HGP II ACETABULAR CUP BON 662406535 HGP II ACETABULAR CUP BON 662406540 HGP II ACETABULAR CUP BON 662406550 HGP II ACETABULAR CUP BON 662406560 HGP II ACETABULAR CUP BON For use in total hip arthroplasty

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

    Product 57 consists of all product code: JDI and same usage: Item no: 763401000 PRESSFIT FEM ST FX 10 X 115 763401100 PRESSFIT FEM ST FX 11 X 1 763401200 PRESSFIT FEM ST FX 12 X 1 763401300 PRESSFIT FEM ST FX 13 X 1 763401400 PRESSFIT FEM ST FX 14 X 1 763401500 PRESSFIT FEM ST FX 15 X 1 For use in total or hemi hip arthroplasty

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

    Product 71 consists of all product under product code: JDI and same usage: Item no: 783401000 VERSYS PRESS FIT LD/FX ST 783401100 VERSYS PRESS FIT LD/FX SZ 783401200 VERSYS PRESS FIT LD/FX SZ 783401300 VERSYS PRESS FIT LD/FX SZ 783401400 VERSYS PRESS FIT LD/FX SZ 783401500 VERSYS PRESS FIT LD/FX SZ 783401600 VERSYS PRESS FIT LD/FX SZ 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

    Product 12 consists of all product under product code JDI , and same usage: Item no: 902602935 6 DEGREE COCR FEM HEAD 28 902602835 6 DEGREE COCR FEM HEAD 28 902603235 6 DEGREE COCR FEM HEAD 32 902603335 6 DEGREE COCR FEM HEAD 32 902603600 6 DEGREE COCR FEM HEAD 36 902603610 6 DEGREE COCR FEM HEAD 36 902603614 6 DEGREE COCR FEM HEAD 36 Product Usage: For use in total or hemi hip arthroplasty

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

    Product 70 consists of all product under product code: JDI and same usage: Item no: 785701000 VERSYS HERITAGE FEM STEM 785701100 VERSYS HERITAGE FEM STEM 785701200 VERSYS HERITAGE FEM STEM 785701300 VERSYS HERITAGE FEM STEM 785701320 VERSYS HERITAGE FEM STEM 785701400 VERSYS HERITAGE FEM STEM 785701420 VERSYS HERITAGE FEM STEM 785701500 VERSYS HERITAGE FEM STEM 785701520 VERSYS HERITAGE FEM STEM 785701600 VERSYS HERITAGE FEM STEM 785701700 VERSYS HERITAGE FEM STEM For use in total or hemi hip arthroplasty

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

    Product 11 consists of all product under product code JDI , and same usage: Item no: 902602500 6 DEGREE COCR FEM HEAD 26 902602600 6 DEGREE COCR FEM HEAD 26 902602700 6 DEGREE COCR FEM HEAD 26 902602800 6 DEGREE COCR FEM HEAD 28 902602900 6 DEGREE COCR FEM HEAD 28 902603000 6 DEGREE COCR FEM HEAD 28 902603300 6 DEGREE COCR FEM HEAD 32 902603200 6 DEGREE COCR FEM HEAD 32 Product Usage: For use in total or hemi hip arthroplasty

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

    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 66 consists of all product under product code: JDI and same usage: Item no: 785001100 VERSYS ADVOCATE CEMENTED 785001200 VERSYS ADVOCATE CEMENTED 785001220 VERSYS ADVOCATE CEMENTED 785001300 VERSYS ADVOCATE CEMENTED 785001320 VERSYS ADVOCATE CEMENTED 785001400 VERSYS ADVOCATE CEMENTED 785001420 VERSYS ADVOCATE CEMENTED 785001500 VERSYS ADVOCATE CEMENTED 785001520 VERSYS ADVOCATE CEMENTED 785001600 VERSYS ADVOCATE CEMENTED 785001620 VERSYS ADVOCATE CEMENTED 785001700 VERSYS ADVOCATE CEMENTED 785001305 VERSYS ADVOCATE V-LIGN CE 785001325 VERSYS ADVOCATE V-LIGN CE 785001405 VERSYS ADVOCATE V-LIGN CE 785001505 VERSYS ADVOCATE V-LIGN CE 785001525 VERSYS ADVOCATE V-LIGN CE For use in total or hemi hip arthroplasty

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

    Product 67 consists of all product under product code: JDI and same usage: Item no: 785001100 VERSYS ADVOCATE CEMENTED 785001200 VERSYS ADVOCATE CEMENTED 785001220 VERSYS ADVOCATE CEMENTED 785001300 VERSYS ADVOCATE CEMENTED 785001320 VERSYS ADVOCATE CEMENTED 785001400 VERSYS ADVOCATE CEMENTED 785001420 VERSYS ADVOCATE CEMENTED 785001500 VERSYS ADVOCATE CEMENTED 785001520 VERSYS ADVOCATE CEMENTED 785001600 VERSYS ADVOCATE CEMENTED 785001620 VERSYS ADVOCATE CEMENTED 785001700 VERSYS ADVOCATE CEMENTED 785001305 VERSYS ADVOCATE V-LIGN CE 785001325 VERSYS ADVOCATE V-LIGN CE 785001405 VERSYS ADVOCATE V-LIGN CE 785001505 VERSYS ADVOCATE V-LIGN CE 785001525 VERSYS ADVOCATE V-LIGN CE For use in total or hemi hip arthroplasty

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