BEUDAMED
    22 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    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

    Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.

    FDA Enforcement
    Class II ·Ongoing·LeMaitre Vascular, Inc.·May 21, 2025

    Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)

    FDA Enforcement
    Class II ·Ongoing·International Life Sciences·March 18, 2026

    LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .

    FDA Enforcement
    Class II ·Ongoing·Zest Anchors LLC·July 1, 2020

    Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23

    FDA Enforcement
    Class II ·Ongoing·Applied Medical Resources Corp·January 14, 2026

    Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430.

    FDA Enforcement
    Class II ·Ongoing·Wright Medical Technology Inc·December 29, 2021

    UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool

    FDA Enforcement
    Class II ·Ongoing·Neotract Inc·August 10, 2022

    remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use

    FDA Enforcement
    Class II ·Ongoing·Remel, Inc·February 26, 2025

    remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use

    FDA Enforcement
    Class II ·Ongoing·Remel, Inc·February 26, 2025

    Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.

    FDA Enforcement
    Class II ·Ongoing·Stradis Healthcare·January 18, 2023

    LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.

    FDA Enforcement
    Class II ·Ongoing·Fresenius Kabi USA, LLC·August 6, 2025

    Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.

    FDA Enforcement
    Class II ·Ongoing·Stradis Healthcare·January 18, 2023

    REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292

    FDA Enforcement
    Class II ·Ongoing·Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.·January 31, 2024

    REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile

    FDA Enforcement
    Class II ·Ongoing·Osteomed, LLC·July 19, 2023

    LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.

    FDA Enforcement
    Class II ·Ongoing·Fresenius Kabi USA, LLC·August 6, 2025

    LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.

    FDA Enforcement
    Class II ·Ongoing·Fresenius Kabi USA, LLC·August 6, 2025

    LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.

    FDA Enforcement
    Class II ·Ongoing·Fresenius Kabi USA, LLC·August 6, 2025

    Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also far fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, Lp·November 15, 2017

    Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also far fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, Lp·November 15, 2017

    Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also far fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, Lp·November 15, 2017