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

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    Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42

    FDA 510(k)
    FDA Class 2 ·Radiology

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180169593·Laparoscopic 10mm Clip Appliers 10MM, 33CM, LAP...

    Avalign

    FDA UDI
    Avalign Technologies, Inc.·00190776022846·Accessory Box w/hardware

    SCANLAN® V.I.P™ Instrument Sterilization Trays

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159024548·Metal Sterilization Tray

    OSLEOBRIDGE IDSF SPACER CONECTOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CLEANTEXX POWDERFREE SYNTHETIC LATEX EXAMINATION GLOVE MADE WITH BARRIER-PRO BUTADIENE CO-POLMER

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code LFR·October 27, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

    AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - POSTERIOR

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON)·Product code FTL·July 8, 2013

    CustMbite, Model Number CBT-SRS-UL

    FDA Enforcement
    Class II ·Ongoing·Dental Choice Holding Llc·August 10, 2022

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017