BEUDAMED
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    TDS PRECISION DENTAL BAR

    FDA 510(k)
    FDA Class 2 ·Dental

    Bur PM2-70 80K Steel Ø2.3 St

    FDA UDI
    Bien-Air Surgery SA·17630055503227·

    Bur PM2-70 80K steel Ø2.3mm sterile

    FDA UDI
    Bien-Air Surgery SA·J00711003560011·

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613084837·K-Wire, Double Ended, Trocar Point, Diameter 0....

    MEDTRONIC TRANSCATHETER VALVE

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 9, 2025

    MEDTRONIC TRANSCATHETER VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 9, 2025

    CONFIDA BRECKER CURVE GUIDEWIRE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DQX·April 9, 2025

    Tether™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981035624·Plate - 3 Level - 56mm

    C.T.M. MOBILITY SCOOTER, MODEL H2-686, HS-740, HS-580

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    LATEX EXAMINATION GLOVES-POWDER FREE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    microTargeting™ Drive

    FDA UDI
    FHC, INC.·00873263003565·microTargeting(TM) Manual Drive with mount for ...

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 8, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 18, 2014

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·May 13, 2011

    Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.

    FDA Enforcement
    Class II ·Ongoing·Fisher Diagnostics·April 9, 2025

    Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·May 13, 2020

    Brilliance iCT Computed Tomography X-ray system, Model 728306

    FDA Enforcement
    Class III ·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016

    SOMATOM Confidence -Computed tomography systems Model 10590100

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022

    Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs.

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·August 29, 2012

    SOMATOM Confidence with software syngo.CT VB20 Model #10590100

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021