BEUDAMED
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    HIGH TIBIAL OSTEOTOMY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EBERLE

    FDA UDI
    Eberle GmbH & Co. KG·04050052021221·Aggressive Meniscus Cutter 4,8

    WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE

    FDA 510(k)
    FDA Class 2 ·Radiology

    SENTEC DIGITAL MONITOR MODEL #SDM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ILET BIONIC PANCREAS

    FDA Adverse Event
    Malfunction ·BETA BIONICS, INC.·Product code QFG·April 23, 2026

    LAMITRODE 88

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 24, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014

    CHEMSTRIP® 10 UA

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JIL·June 27, 2011

    ROD, FIXATION, INTRAMEDULLARY

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·May 4, 2016

    ROD, FIXATION, INTRAMEDULLARY

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·May 4, 2016

    ROD, FIXATION, INTRAMEDULLARY

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·May 4, 2016

    INTELLIGENT PUMP ADDITIVE SET WITH FILTER

    FDA Adverse Event
    MCGAW, INC.·Product code FPA·December 4, 1995

    TFNA FEM NAIL Ø11 R 130° L360 TIMO15

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HSB·February 23, 2023

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·April 5, 2018

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014