BEUDAMED
    17 results · 29ms · Sources: EU EUDAMED, US FDA

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    Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AGXO

    FDA UDI
    Sbo Hearing A/S·05714464053377·AGXO F100 MINIRITE R C091

    ORTHOFIX

    FDA UDI
    ORTHOFIX SRL·18059015375312·REVISION LOCKING SCREW L22.5MM D4.0MM

    Vilex Power Accessory

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731122308·KWire .078 x 9"(2.0x225mm))

    Vilex Power Accessory

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731122315·KWire .094 x 9" (2.4x225mm)

    Adler Instrument Company

    FDA UDI
    Adler, Inc.·00810123209491·Mixter Artery Forceps Full Curved, TW 2.4mm OL ...

    ORTHOFIX

    FDA UDI
    ORTHOFIX SRL·18059015374810·REVISION LOCKING SCREW L22.5MM D4.0MM STERILE

    BD VACUTAINER 9NC 0.129M PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·January 5, 2021

    ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO

    FDA 510(k)
    FDA Class 2 ·Immunology

    OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 10MM

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code DZE·August 14, 2019

    FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 24, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    MICRO SAGITTAL SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBE·July 22, 2013

    MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 00850024195141 MP2015A - MOLLI OncoPen UDI (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.

    FDA Enforcement
    Class II ·Ongoing·Stryker Corporation·February 25, 2026

    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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013