BEUDAMED
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    UP-GRADE FOREHEAD THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032362·Baltic Denture System BDLoad Sm6 PLSEbm6DFs A3,...

    BUSCH®, BNA®

    FDA UDI
    BUSCH & CO. GmbH & Co. KG·D8120323621·Diamond, cylinder rounded edge, COOL DIAMANT, c...

    Ophthalmic Spatula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668102626·LIEBERMAN DOUBLE ENDED MICROFINGER, RT

    MODIFICATION TO VASCULAR CLOSURE DEVICE

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

    SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ERBE

    FDA Adverse Event
    Malfunction ·LEONHARD LANG GMBH·Product code GEI·November 2, 2022

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 29, 2013

    SYNCHROMED EL

    FDA Adverse Event
    Injury ·RICE CREEK MANUFACTURING·Product code LKK·March 28, 2011

    INDURA

    FDA Adverse Event
    Injury ·MEDTRONIC INC., NEUROLOGICAL DIVISION·Product code LKK·April 22, 2008

    VOYAGER RX CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-CLONMEL·Product code LOX·December 22, 2010

    ERBE

    FDA Adverse Event
    Malfunction ·LEONHARD LANG GMBH·Product code GEI·March 8, 2023

    ERBE

    FDA Adverse Event
    Malfunction ·LEONHARD LANG GMBH·Product code GEI·February 18, 2025

    EVOLUT FX VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·August 27, 2025

    ERBE

    FDA Adverse Event
    Injury ·LEONHARD LANG GMBH·Product code GEI·July 27, 2022

    I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 31404-28, 31404-30, 31404-32, 31404-34, 31404-36, 31404-38, 31404-40, 31404-42, 31404-44, 31404-46, 31404-48, 31404-50, 31404-55, 31404-60, 31404-65, 31404-70, 31404-75, 31404-80, 31457-30, 31457-36, 31457-40, 31457-46, 31457-50, 31457-55, 31457-60, 31652-100, 31652-105, 31652-110, 31652-115, 31652-120, 31652-25, 31652-30, 31652-35, 31652-40, 31652-45, 31652-55, 31652-60, 31652-65, 31652-70, 31652-75, 31652-80, 31652-85, 31652-90, 31652-95, 31731-100, 31731-105, 31731-110, 31731-115, 31731-120, 31731-50, 31731-60, 31731-65, 31731-70, 31731-75, 31731-80, 31731-85, 31731-90, 31731-95, 31732-60, 31734-100, 31734-105, 31734-110, 31734-115, 31734-120, 31734-45, 31734-50, 31734-60, 31734-65, 31734-70, 31734-75, 31734-80, 31734-85, 31734-90, 31734-95. 2. Cortical Screw, Cannulated; Article Numbers: 31357-44, 31357-22, 31357-48, 31277-18, 31357-20, 31357-22, 31357-24, 31357-26, 31357-28, 31357-30, 31357-32, 31357-34, 31357-36, 31357-38, 31357-40, 31357-42, 31357-44, 31357-46, 31357-48, 31357-60, 31357-65, 31357-70. 3. Washer; Article Number: 36851. 4. Washer, Concave; Article Numbers: 36432, 36653, 36732. 5. Washer, Flat; Article Numbers: 36431, 36651, 36653, 36731.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

    FEM IM NAIL 14MMDX30CM LEFT, FEM IM NAIL 14MMDX30CM RIGHT FEM IM NAIL 13MMDX32CM LEFT FEM IM NAIL 14MMDX32CM LEFT FEM IM NAIL 13MMDX32CM RIGHT FEM IM NAIL 14MMDX32CM RIGHT FEM IM NAIL 11MMDX34CM LEFT FEM IM NAIL 13MMDX34CM LEFT FEM IM NAIL 14MMDX34CM LEFT FEM IM NAIL 11MMDX34CM RIGHT FEM IM NAIL 13MMDX34CM RIGHT FEM IM NAIL 14MMDX34CM RIGHT FEM IM NAIL 11MMDX36CM LEFT FEM IM NAIL 12MMDX36CM LEFT FEM IM NAIL 13MMDX36CM LEFT FEM IM NAIL 14MMDX36CM LEFT FEM IM NAIL 11MMDX36CM RIGHT FEM IM NAIL 12MMDX36CM RIGHT FEM IM NAIL 13MMDX36CM RIGHT FEM IM NAIL 14MMDX36CM RIGHT FEM IM NAIL 10MMDX38CM LEFT FEM IM NAIL 11MMDX38CM LEFT FEM IM NAIL 12MMDX38CM LEFT FEM IM NAIL 13MMDX38CM LEFT FEM IM NAIL 14MMDX38CM LEFT FEM IM NAIL 10MMDX38CM RIGHT FEM IM NAIL 11MMDX38CM RIGHT FEM IM NAIL 12MMDX38CM RIGHT FEM IM NAIL 13MMDX38CM RIGHT FEM IM NAIL 14MMDX38CM RIGHT FEM IM NAIL 10MMDX40CM LEFT FEM IM NAIL 11MMDX40CM LEFT FEM IM NAIL 12MMDX40CM LEFT FEM IM NAIL 13MMDX40CM LEFT FEM IM NAIL 14MMDX40CM LEFT FEM IM NAIL 10MMDX40CM RIGHT FEM IM NAIL 11MMDX40CM RIGHT FEM IM NAIL 12MMDX40CM RIGHT FEM IM NAIL 13MMDX40CM RIGHT FEM IM NAIL 14MMDX40CM RIGHT FEM IM NAIL 10MMDX42CM LEFT FEM IM NAIL 11MMDX42CM LEFT FEM IM NAIL 12MMDX42CM LEFT FEM IM NAIL 13MMDX42CM LEFT FEM IM NAIL 14MMDX42CM LEFT FEM IM NAIL 10MMDX42CM RIGHT FEM IM NAIL 11MMDX42CM RIGHT FEM IM NAIL 12MMDX42CM RIGHT FEM IM NAIL 13MMDX42CM RIGHT FEM IM NAIL 14MMDX42CM RIGHT FEM IM NAIL 10MMDX44CM LEFT FEM IM NAIL 11MMDX44CM LEFT FEM IM NAIL 12MMDX44CM LEFT FEM IM NAIL 13MMDX44CM LEFT FEM IM NAIL 14MMDX44CM LEFT FEM IM NAIL 10MMDX44CM RIGHT FEM IM NAIL 11MMDX44CM RIGHT FEM IM NAIL 12MMDX44CM RIGHT FEM IM NAIL 13MMDX44CM RIGHT FEM IM NAIL 14MMDX44CM RIGHT FEM IM NAIL 10MMDX46CM LEFT FEM IM NAIL 11MMDX46CM LEFT FEM IM NAIL 12MMDX46CM LEFT FEM IM NAIL 13MMDX46CM LEFT FEM IM NAIL 14MMDX46CM LEFT FEM IM NAIL 10MMDX46CM RIGHT FEM IM NAIL 11MMDX46CM RIGHT FEM IM NAIL 12MMDX46CM RIGHT FEM IM NAIL 13MMDX46CM RIGHT FEM IM NAIL 14MMDX46CM RIGHT FEM IM NAIL 10MMDX48CM LEFT FEM IM NAIL 11MMDX48CM LEFT FEM IM NAIL 12MMDX48CM LEFT FEM IM NAIL 13MMDX48CM LEFT FEM IM NAIL 10MMDX48CM RIGHT FEM IM NAIL 11MMDX48CM RIGHT FEM IM NAIL 12MMDX48CM RIGHT FEM IM NAIL 13MMDX48CM RIGHT FEM IM NAIL 10MMDX50CM LEFT FEM IM NAIL 11MMDX50CM LEFT FEM IM NAIL 12MMDX50CM LEFT FEM IM NAIL 13MMDX50CM LEFT FEM IM NAIL 10MMDX50CM RIGHT FEM IM NAIL 11MMDX50CM RIGHT FEM IM NAIL 12MMDX50CM RIGHT FEM IM NAIL 13MMDX50CM RIGHT

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024