BEUDAMED
    16 results · 23ms · Sources: EU EUDAMED, US FDA

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    HKT Anatomical Locking Trauma System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD BBL™ Sensi-Disc™ Clindamycin 2 µg

    FDA UDI
    BECTON, DICKINSON AND COMPANY·00382902312130·BD BBL™ Sensi-Disc™ Clindamycin 2 µg

    Certi-Gauze Pads - 4"x 4" - 25/Box

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588312132·Certi-Gauze Pads - 4"x 4" - 25/Box

    DRILL, AO, STERILE 4, 2X340 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·September 23, 2011

    AQUASENS FLUID MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·February 9, 2026

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008

    IN TOUCH ZX

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·July 18, 2011

    GYNECARE PROLIFT +M POSTERIOR PELVIC FLOOR REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·July 17, 2013

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code KMW·December 19, 2023

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020