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

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    MiiS Horus Scope DPT 100

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Regatta Lateral System

    FDA UDI
    Seaspine Orthopedics Corporation·10889981158422·Lateral Implant, 18mm x 12mm x 60mm, 10 Deg

    Regatta Lateral System

    FDA UDI
    Seaspine Orthopedics Corporation·10889981158439·Lateral Implant, 18mm x 12mm x 60mm, 15 Deg

    Regatta

    FDA UDI
    Seaspine Orthopedics Corporation·10889981158415·Lateral Implant, 18mm x 12mm x 60mm, 0 Deg

    KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    A/C ENZYMATIC VITAMIN B6 ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·November 11, 2019

    SERVO-I BASE UNIT

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·December 30, 2024

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 25, 2024

    OMNIPOD 5 CONTROLLER

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code QFG·March 28, 2024

    1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER - INTERNATIONAL KIT

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code GCJ·September 13, 2024

    GYNECARE PROLIFT PELVIC FLOOR REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·June 21, 2013

    THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-M-TE4BE1EB

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL, IRVINE·Product code OAD·July 8, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014

    Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Left, Part No. LJU210T

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·April 24, 2019

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·LABSTYLE INNOVATIONS LTD.·Product code NBW·September 28, 2023

    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

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018