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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Rejoyn

    FDA 510(k)
    FDA Class 2 ·Neurology

    Certi-Gauze Pads - 2"x 2" - 25/Box

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588312095·Certi-Gauze Pads - 2"x 2" - 25/Box

    GE 1.5T 8 CHANNEL TORSO COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    TERASON USMART3200T ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    COCHLEAR OSIA OSI300 IMPLANT

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code PFO·March 8, 2026

    COCHLEAR OSIA OSI300 IMPLANT

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code PFO·January 15, 2024

    COCHLEAR OSIA OSI300 IMPLANT

    FDA Adverse Event
    Injury ·COCHLEAR LIMITED·Product code PFO·January 15, 2024

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

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

    SECURE II MED/SURG BED

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

    UNKNOWN DEPUY FEMORAL HEAD

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JDI·July 17, 2013

    STARDRIVE SCREWDRIVER SHAFT T8 105MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code KWQ·November 6, 2017

    CARTO 3

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·September 16, 2024

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·May 21, 2024

    CARTO 3

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·October 28, 2025

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·April 17, 2024

    CARTO 3

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·October 15, 2025

    Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number: 86566621 Intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF) radiopharmaceuticals and commonly used flushing solutions to patients during molecular imaging (PET Positron Emission Tomography - nuclear medicine) diagnostic procedures.

    FDA Enforcement
    Class II ·Ongoing·Bayer Medical Care, Inc.·January 18, 2023

    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217.

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

    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

    Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 178575 178576 178577 178578 178579 178580 178730 178731 178732 178733 178734 178735 178354S 178754 178755 178756 178757 178758 178759 Product Usage: 1) Correction of revision of unsuccessful osteotomy, arthrodesis or previous joint replacement 2) Tumor resections 3) Revision of previously failed total joint arthroplasty 4) Trauma The ComPreSs Distal Femoral Replacement System is intended for uncemented use.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019