BEUDAMED
    84 results · 15ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    LPS POROUS FEM IMPLANT SZ G-L LPS PRECOAT FEM IMPLANT SZ G-L This device is indicated for patients with severe knee pain and disability

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Tornier, Inc·August 5, 2015

    LPS-FLEX GSF OPT SZ C-L¿ LPS-FLEX GSF OPT SZ C-R¿ LPS-FLEX GSF OPT SZ D-L¿ LPS-FLEX GSF OPT SZ D-R¿ LPS-FLEX GSF OPT SZ E-L¿ LPS-FLEX GSF OPT SZ E-R¿ LPS-FLEX GSK OPT SZ F-L¿ LPS-FLEX GSF OPT SZ F-R¿ LPS-FLEX GSF OPT SZ G-L¿ LPS-FLEX GSF OPT SZ G-R¿

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·November 19, 2014

    Palmero Healthcare, LLC DisCide Ultra Surface Disinfectant Cleaner Quaternary Based Manual Pour Liquid 1 gal. Jug Herbal Scent NonSterile Model Number: 3565G

    FDA Enforcement
    Class II ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022

    Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc.·February 12, 2014

    LPS FEM COMP SZ B-L LPS FEM COMP SZ B-R LPS FEM COMP SZ C-L LPS FEM COMP SZ C-R LPS FEM COMP SZ D-L LPS FEM COMP SZ D-R LPS FEM COMP SZ E-L LPS FEM COMP SZ E-R LPS FEM COMP SZ F-L LPS FEM COMP SZ F-R LPS FEM COMP SZ G-L LPS FEM COMP SZ G-R This device is indicated for patients with severe knee pain and disability

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone Device Common Name: Drill Guide DNP 3.3mm Labeling: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT NB0311 QTY 1 DePuy P.O Box 988 Warsaw IN 46581

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·August 20, 2014

    Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)

    FDA Enforcement
    Class II ·Terminated·Conformis, Inc.·September 2, 2020

    CR-FLEX GSF PRECOAT SZ C-L¿ CR-FLEX GSF PRECOAT SZ C-R¿ CR-FLEX GSF PRECOAT SZ D-L¿ CR-FLEX GSF PRECOAT SZ D-R¿ CR-FLEX GSF PRECOAT SZ E-L¿ CR-FLEX GSF PRECOAT SZ E-R¿ CR-FLEX GSF PRECOAT SZ F-L¿ CR-FLEX GSF PRECOAT SZ F-R¿ CR-FLEX GSF PRECOAT SZ G-L¿ CR-FLEX GSK PRECOAT SZ G-R¿ " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·February 7, 2018

    Affixus Hip Fracture Nail, 130 DEG 11MM X 180MM

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·February 7, 2018

    Affixus Hip Fracture Nail, 130 DEG 9MM X 180MM

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·February 7, 2018

    Affixus Hip Fracture Nail, RH 130 DEG 11MM X 400MM

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·February 7, 2018

    Affixus Hip Fracture Nail, LH 125 DEG 9MM X 440MM

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·February 7, 2018

    Affixus Hip Fracture Nail, RH 125 DEG 9MM X 460MM

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·February 7, 2018

    Affixus Hip Fracture Nail, RH 125 DEG 11MM X 440MM

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·February 7, 2018

    Affixus Hip Fracture Nail, LH 125 DEG 9MM X 260MM

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·February 7, 2018

    Affixus Hip Fracture Nail, LH 125 DEG 11MM X 440MM

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·February 7, 2018

    Affixus Hip Fracture Nail, RH 130 DEG 11MM X 380MM

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·February 7, 2018