BEUDAMED
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    ATAL-8

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526799431·MANUMED ACTIVE WRIST RIGHT SAND S

    Carbide burs

    FDA UDI
    DFS - DIAMON GmbH·04057176150639·Carbide Paro IV CA XL 1,2 mm

    7450 RV2 MASK

    FDA UDI
    HANS RUDOLPH, INC.·00874750005451·7450 V2 LG MASK W/HG/FLEX MA

    CapSure® Spine System

    FDA UDI
    Spine Wave, Inc.·10840642105285·PS3 Screw 8.5mm x 120mm

    MDT Diamond Coated Dental Burs

    FDA UDI
    M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·57291046204851·FG Rotary diamond instrument for dental applica...

    MDT Diamond Coated Dental Burs

    FDA UDI
    M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·57291046249883·FG Rotary diamond instrument for dental applica...

    MDT Diamond Coated Dental Burs

    FDA UDI
    M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·57291046318169·Rotary diamond instrument for dental application

    MITRA-LIFT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPIROLAB II, MODEL 29

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X300MM X 12

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·November 7, 2012

    MONGOOSE ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO.LTD.·Product code DQO·December 15, 2017

    TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code JEY·May 31, 2019

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·May 15, 2013

    GEMSTAR 7 THERAPY FR

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·September 17, 2014

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·May 13, 2011

    WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code LZD·August 29, 2017

    BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HWC·June 3, 2016

    LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.

    FDA Enforcement
    Class I ·Terminated·DePuy Orthopaedics, Inc.·February 27, 2013

    Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)

    FDA Enforcement
    Class II ·Ongoing·Isopure Corp·July 20, 2022